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kzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
Evaluation of onset of effect in patients with severe Chronic Obstructive Pulmonary Disease (COPD) treated with Symbicort® compared to Seretide® - SPEED
Study identifier:D5892C00016
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A double-blind, randomised, cross-over, multi-centre study, to evaluate onset of effect in the morning in patients with severe Chronic Obstructive Pulmonary Disease (COPD) treated with Symbicort®Turbuhaler® 320/9 μg, compared with Seretide® Diskus® 50/500 μg, both given as one inhalation twice daily for one week each.
Medical condition
Chronic obstructive pulmonary disease (COPD)
Phase
Phase 4
Healthy volunteers
No
Study drug
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg, Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Sex
All
Actual Enrollment
442
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Sept 2007
Primary Completion Date: 01 Aug 2008
Study Completion Date: 01 Aug 2008
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Location
Research Site
MONTE GRANDE, Buenos Aires, Argentina
Location
Research Site
QUILMES, Buenos Aires, Argentina
Location
Research Site
San Miguel de Tucuman, Tucuman, Argentina
Location
Research Site
CIUDAD AUTONOMA DE BS. AS., Argentina
Location
Research Site
CIUDAD DE BUENOS AIRES, Argentina
Location
Research Site
CONCORD, NSW, Australia
Location
Research Site
ADELAIDE, SA, Australia
Location
Research Site
DAW PARK, SA, Australia
| Arms | Assigned Interventions |
|---|---|
| Experimental: Symbicort Turbuhaler First, then Seretide Diskus Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg | - |
| Experimental: Seretide Diskus First, then Symbicort Turbuhaler Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg | - |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 706 subjects were enrolled; 264 were not randomised: 190 with eligibility not fulfilled, 11 with adverse events, 4 with discontinuation criteria, 40 voluntary discontinuations, 2 lost to follow-ups, 6 non-compliance, 1 for safety reasons, 10 with other reasons not specified. 442 subjects were randomised |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler First, then Seretide Diskus | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
| Seretide Diskus First, then Symbicort Turbuhaler | Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
Participant Flow for 3 periods
Period 1: Period 1| Symbicort Turbuhaler First, then Seretide Diskus | Seretide Diskus First, then Symbicort Turbuhaler | |
|---|---|---|
| STARTED | 217[1] | 225 |
| COMPLETED | 211 | 213 |
| NOT COMPLETED | 6 | 12 |
| Eligibility criteria not fulfilled | 2 | 6 |
| Adverse Event | 2 | 2 |
| Development of study-specific criteria | 1 | 2 |
| Withdrawal by Subject | 1 | 1 |
| Protocol Violation | 0 | 1 |
| [1] | This was a cross-over study |
|---|
| Symbicort Turbuhaler First, then Seretide Diskus | Seretide Diskus First, then Symbicort Turbuhaler | |
|---|---|---|
| STARTED | 211 | 213 |
| COMPLETED | 204 | 203 |
| NOT COMPLETED | 7 | 10 |
| Adverse Event | 5 | 7 |
| Eligibility not fulfilled | 0 | 1 |
| Discontinuation criteria | 2 | 0 |
| Severe non-compliance | 0 | 1 |
| Not specified | 0 | 1 |
| Symbicort Turbuhaler First, then Seretide Diskus | Seretide Diskus First, then Symbicort Turbuhaler | |
|---|---|---|
| STARTED | 204 | 203 |
| COMPLETED | 204 | 201 |
| NOT COMPLETED | 0 | 2 |
| Adverse Event | 0 | 2 |
Baseline Characteristics
Analysis Population Description -- Explanation of how the number of participants for analysis was determined.
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler First, then Seretide Diskus | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
| Seretide Diskus First, then Symbicort Turbuhaler | Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
Baseline Measures
| Symbicort Turbuhaler First, then Seretide Diskus | Seretide Diskus First, then Symbicort Turbuhaler | Total | |
|---|---|---|---|
|
Number of Participants
[units: Participants] |
217 | 225 | 442 |
| Age Continuous [units: years] Mean ( Full Range ) |
62.9 (41 to 82) | 63.2 (40 to 86) | 63.1 (40 to 86) |
| Gender, Male/Female [units: Participants] |
|||
| Female | 55 | 71 | 126 |
| Male | 162 | 154 | 316 |
Outcome Measures
1. Primary Outcome Measure: Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]
| Measure Type | Primary |
|---|---|
| Measure Name | Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose |
| Measure Description | The change from baseline in PEF was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and all days of treatment, with baseline as covariate. |
| Time Frame | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Measured Values
| Symbicort Turbuhaler | Seretide Diskus | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
385 | 390 |
| Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose [units: liters/minute] Mean (Standard Deviation) |
15.1 (28.5) | 13.4 (28.2) |
No statistical analysis provided for Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose
2. Secondary Outcome Measure: PEF Before Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]
| Measure Type | Secondary |
|---|---|
| Measure Name | PEF Before Morning Dose |
| Measure Description | The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. |
| Time Frame | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Measured Values
| Symbicort Turbuhaler | Seretide Diskus | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
416 | 425 |
| PEF Before Morning Dose [units: Liters/minutes] Mean (Standard Deviation) |
4.8 (28.2) | 7.9 (24) |
No statistical analysis provided for PEF Before Morning Dose
3. Secondary Outcome Measure: PEF 15 Minutes After Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]
| Measure Type | Secondary |
|---|---|
| Measure Name | PEF 15 Minutes After Morning Dose |
| Measure Description | The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. |
| Time Frame | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Measured Values
| Symbicort Turbuhaler | Seretide Diskus | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
377 | 389 |
| PEF 15 Minutes After Morning Dose [units: Liters/minute] Mean (Standard Deviation) |
19.9 (30.3) | 16.7 (28.5) |
No statistical analysis provided for PEF 15 Minutes After Morning Dose
4. Secondary Outcome Measure: PEF Before Evening Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]
| Measure Type | Secondary |
|---|---|
| Measure Name | PEF Before Evening Dose |
| Measure Description | The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. |
| Time Frame | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Measured Values
| Symbicort Turbuhaler | Seretide Diskus | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
418 | 426 |
| PEF Before Evening Dose [units: Liters/minute] Mean (Standard Deviation) |
4 (24.3) | 1.8 (50) |
No statistical analysis provided for PEF Before Evening Dose
5. Secondary Outcome Measure: Forced Expiratory Volume in 1 second (FEV1) Before Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Forced Expiratory Volume in 1 second (FEV1) Before Morning Dose |
| Measure Description | The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. |
| Time Frame | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Includes all subjects with at least one dose of study medication and contribute sufficient data for the endpoint to be calculated. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Measured Values
| Symbicort Turbuhaler | Seretide Diskus | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
280 | 269 |
| Forced Expiratory Volume in 1 second (FEV1) Before Morning Dose [units: Liters] Mean (Standard Deviation) |
0.0310 (0.2460) | 0.0590 (0.2310) |
No statistical analysis provided for Forced Expiratory Volume in 1 second (FEV1) Before Morning Dose
6. Secondary Outcome Measure: FEV1 15 Minutes After Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]
| Measure Type | Secondary |
|---|---|
| Measure Name | FEV1 15 Minutes After Morning Dose |
| Measure Description | The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. |
| Time Frame | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Includes all subjects with at least one dose of study medication and contribute sufficient data for the endpoint to be calculated. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Measured Values
| Symbicort Turbuhaler | Seretide Diskus | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
249 | 249 |
| FEV1 15 Minutes After Morning Dose [units: Liters] Mean (Standard Deviation) |
0.1220 (0.2530) | 0.1030 (0.3720) |
No statistical analysis provided for FEV1 15 Minutes After Morning Dose
7. Secondary Outcome Measure: FEV1 Before Evening Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]
| Measure Type | Secondary |
|---|---|
| Measure Name | FEV1 Before Evening Dose |
| Measure Description | The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. |
| Time Frame | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Measured Values
| Symbicort Turbuhaler | Seretide Diskus | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
248 | 243 |
| FEV1 Before Evening Dose [units: Liters] Mean (Standard Deviation) |
0.1470 (0.2470) | 0.1060 (0.2010) |
No statistical analysis provided for FEV1 Before Evening Dose
8. Secondary Outcome Measure: Change in PEF from Before Dose to 5 Minutes After Dose in the Morning [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change in PEF from Before Dose to 5 Minutes After Dose in the Morning |
| Measure Description | The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with pre-dose run-in/washout as covariate. |
| Time Frame | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Measured Values
| Symbicort Turbuhaler | Seretide Diskus | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
279 | 279 |
| Change in PEF from Before Dose to 5 Minutes After Dose in the Morning [units: Liters/minute] Mean (Standard Deviation) |
0.0160 (0.2) | 0.0030 (0.299) |
No statistical analysis provided for Change in PEF from Before Dose to 5 Minutes After Dose in the Morning
9. Secondary Outcome Measure: Change in PEF from Before Dose to 15 Minutes After Dose in the Morning [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change in PEF from Before Dose to 15 Minutes After Dose in the Morning |
| Measure Description | The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate. |
| Time Frame | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Measured Values
| Symbicort Turbuhaler | Seretide Diskus | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
368 | 376 |
| Change in PEF from Before Dose to 15 Minutes After Dose in the Morning [units: Liters/minute] Mean (Standard Deviation) |
11.6 (16.2) | 6.1 (16.5) |
No statistical analysis provided for Change in PEF from Before Dose to 15 Minutes After Dose in the Morning
10. Secondary Outcome Measure: Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning |
| Measure Description | The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate. |
| Time Frame | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Measured Values
| Symbicort Turbuhaler | Seretide Diskus | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
368 | 376 |
| Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning [units: Liters] Mean (Standard Deviation) |
15.8 (20.8) | 9.6 (19.9) |
No statistical analysis provided for Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning
11. Secondary Outcome Measure: Change in FEV1 from Before Dose to 15 Minutes After Dose in the Morning [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change in FEV1 from Before Dose to 15 Minutes After Dose in the Morning |
| Measure Description | The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate. |
| Time Frame | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Measured Values
| Symbicort Turbuhaler | Seretide Diskus | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
233 | 238 |
| Change in FEV1 from Before Dose to 15 Minutes After Dose in the Morning [units: Liters] Mean (Standard Deviation) |
0.0930 (0.1870) | 0.0280 (0.1630) |
No statistical analysis provided for Change in FEV1 from Before Dose to 15 Minutes After Dose in the Morning
12. Secondary Outcome Measure: Change in FEV1 from Before Dose to 5 Minutes After Dose at the Clinic [ Time Frame: Baseline (run-in, and washout) and day 1 of treatment period ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change in FEV1 from Before Dose to 5 Minutes After Dose at the Clinic |
| Measure Description | The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate. |
| Time Frame | Baseline (run-in, and washout) and day 1 of treatment period |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Measured Values
| Symbicort Turbuhaler | Seretide Diskus | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
233 | 238 |
| Change in FEV1 from Before Dose to 5 Minutes After Dose at the Clinic [units: Liters] Mean (Standard Deviation) |
0.1120 (0.1950) | 0.0440 (0.1640) |
No statistical analysis provided for Change in FEV1 from Before Dose to 5 Minutes After Dose at the Clinic
13. Secondary Outcome Measure: Change in Forced Vital capacity (FVC) from Before Dose to5 Minutes After Dose at the Clinic [ Time Frame: Baseline (run-in, and washout) and day 1 of treatment period ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change in Forced Vital capacity (FVC) from Before Dose to5 Minutes After Dose at the Clinic |
| Measure Description | The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate. |
| Time Frame | Baseline (run-in, and washout) and day 1 of treatment period |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Measured Values
| Symbicort Turbuhaler | Seretide Diskus | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
415 | 426 |
| Change in Forced Vital capacity (FVC) from Before Dose to5 Minutes After Dose at the Clinic [units: Liters] Mean (Standard Deviation) |
0.0950 (0.1370) | 0.0490 (0.1060) |
No statistical analysis provided for Change in Forced Vital capacity (FVC) from Before Dose to5 Minutes After Dose at the Clinic
14. Secondary Outcome Measure: Capacity of Daily Living in the Morning (CDLM) (Change from pre to end of treatment) [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Capacity of Daily Living in the Morning (CDLM) (Change from pre to end of treatment) |
| Measure Description | The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best. |
| Time Frame | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
| Safety Issue? | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus First | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Measured Values
| Symbicort Turbuhaler | Seretide Diskus First | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
415 | 426 |
| Capacity of Daily Living in the Morning (CDLM) (Change from pre to end of treatment) [units: units on a scale] Mean (Standard Deviation) |
0.1920 (0.2530) | 0.1240 (0.2310) |
No statistical analysis provided for Capacity of Daily Living in the Morning (CDLM) (Change from pre to end of treatment)
15. Secondary Outcome Measure: Difficulty in Getting out from Bed (MASQ) (Change from pre to end of treatment) [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Difficulty in Getting out from Bed (MASQ) (Change from pre to end of treatment) |
| Measure Description | The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best. |
| Time Frame | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Measured Values
| Symbicort Turbuhaler | Seretide Diskus | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
319 | 311 |
| Difficulty in Getting out from Bed (MASQ) (Change from pre to end of treatment) [units: Units on a scale] Mean (Standard Deviation) |
0.21 (0.64) | 0.14 (0.75) |
No statistical analysis provided for Difficulty in Getting out from Bed (MASQ) (Change from pre to end of treatment)
16. Secondary Outcome Measure: The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change from pre to end of treatment) [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]
| Measure Type | Secondary |
|---|---|
| Measure Name | The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change from pre to end of treatment) |
| Measure Description | The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 6 with 0=worst and 6 = best. |
| Time Frame | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Measured Values
| Symbicort Turbuhaler | Seretide Diskus | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
394 | 396 |
| The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change from pre to end of treatment) [units: Units on a scale] Mean (Standard Deviation) |
0.24 (0.75) | 0.19 (0.73) |
No statistical analysis provided for The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change from pre to end of treatment)
Serious Adverse Events
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Serious Adverse Events
| Symbicort Turbuhaler | Seretide Diskus | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Total, serious adverse events | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 3/420 (0.71%) | 1/429 (0.23%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| General disorders and administration site conditions | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Gait disturbance1, † | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 1/420 (0.24%) | 0/429 (0.00%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Respiratory, thoracic and mediastinal disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Chronic obstructive oulmonary disease1, † | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 2/420 (0.48%) | 1/429 (0.23%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Other Adverse Events
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Frequency Threshold
| Threshold above which other adverse events are reported | 5% |
|---|
Reporting Groups
| Description | |
|---|---|
| Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Other Adverse Events
| Symbicort Turbuhaler | Seretide Diskus | |
|---|---|---|
| Total, other (not including serious) adverse events | ||
| # participants affected / at risk | 0/420 (0.00%) | 0/429 (0.00%) |
Certain Agreements
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact
| Name/Title: | Gerard Lynch |
| Organization: | AstraZeneca |
| E-mail: | [email protected] |
Contacts
Investigators
Principal Investigator
Tomas Andersson
AstraZeneca
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hOOU56EiQQwzYiEgvA%2F1WSUkzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
