Safety and efficacy study of Budesonide (Pulmicort®) Turbuhaler® in Japanese children with bronchial asthma

Study identifier:D5254C00006

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An open-label, multi-center, long term study to investigate the safety and efficacy of budesonide Turbuhaler® treatment for 48 weeks (following 6 weeks Phase III study) in Japanese children with bronchial asthma aged 5 years to 15 years old

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

Study drug

Budesonide, Conventional Asthma Therapy

Sex

All

Actual Enrollment

241

Study type

Interventional

Age

5 Years - 15 Years

Date

Study Start Date: 01 Dec 2006

Primary Completion Date: 01 Oct 2008

Study Completion Date: 01 Oct 2008

Study design

Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2012 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Takizawa, Iwate, Japan

Arms	Assigned Interventions
Experimental: BUD - Budesonide Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily	Drug: Budesonide Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily Other Name: Pulmicort® Turbuhaler®
Active Comparator: CONV - Conventional Asthma Therapy Conventional Asthma Therapy - according to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.	Drug: Conventional Asthma Therapy According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
241 Japanese paediatric patients were enrolled into the study

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was an open-label, multi-centre, long-term study in Japanese children with bronchial asthma aged 5 to 15 years, and conducted as an extension of the Phase III study D5254C00769.

Reporting Groups

	Description
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Participant Flow: Overall Study

	Budesonide	Conventional Therapy
STARTED	121	120
COMPLETED	109	113
NOT COMPLETED	12	7
Adverse Event	2	0
Withdrawal by Subject	4	3
Lost to Follow-up	0	1
Protocol Violation	4	2
Non-compliance	2	1

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Baseline Measures

	Budesonide	Conventional Therapy	Total
Number of Participants [units: Participants]	121	120	241
Age Continuous [units: Years] Mean ± Standard Deviation	8.9 ± 2.6	8.6 ± 2.3	8.8 ± 2.5
Gender, Male/Female [units: Participants]
Female	36	27	63
Male	85	93	178

Outcome Measures

1. Primary Outcome Measure: Number of patients with Adverse Events (AEs). [ Time Frame: 54 weeks ]

Measure Type	Primary
Measure Name	Number of patients with Adverse Events (AEs).
Measure Description	AEs were defined as undesirable medical conditions or deteriorations of a pre-existing medical condition following/during exposure. All Serious AEs, AEs leading to withdrawal, Other relevant AE were recorded.
Time Frame	54 weeks
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.

Reporting Groups

	Description
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Measured Values

	Budesonide	Conventional Therapy
Number of Participants Analyzed [units:participants]	121	120
Number of patients with Adverse Events (AEs). [units: Participants]	118	116

No statistical analysis provided for Number of patients with Adverse Events (AEs).

2. Secondary Outcome Measure: Number of patients with abnormal clinical laboratory test values. [ Time Frame: 54 weeks ]

Measure Type	Secondary
Measure Name	Number of patients with abnormal clinical laboratory test values.
Measure Description	Analysis of haematological, clinical chemistry and urynalysis variables were performed. Haematology variables: erythrocytes, haemoglobin, haematocrit, leucocyte count, leucocyte different count (neutrophils, eosinophils, basophils, lymphocytes, monocytes), platelet count. Clinical chemistry measurements: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin, albumin, creatinine,sodium, potassium, total protein, blood urea nitrogen. Urinalysis variables: protein, glucose, urobilinogen, occult.
Time Frame	54 weeks
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.

Reporting Groups

	Description
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Measured Values

	Budesonide	Conventional Therapy
Number of Participants Analyzed [units:participants]	121	120
Number of patients with abnormal clinical laboratory test values. [units: Participants]	0	0

No statistical analysis provided for Number of patients with abnormal clinical laboratory test values.

3. Secondary Outcome Measure: Number of patients with abnormal vital sign values for the following variables: Blood pressure (sitting) and Pulse rate (sitting), as judged by the investigator [ Time Frame: 54 weeks ]

Measure Type	Secondary
Measure Name	Number of patients with abnormal vital sign values for the following variables: Blood pressure (sitting) and Pulse rate (sitting), as judged by the investigator
Measure Description
Time Frame	54 weeks
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.

Reporting Groups

	Description
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Measured Values

	Budesonide	Conventional Therapy
Number of Participants Analyzed [units:participants]	121	120
Number of patients with abnormal vital sign values for the following variables: Blood pressure (sitting) and Pulse rate (sitting), as judged by the investigator [units: Participants]	0	0

No statistical analysis provided for Number of patients with abnormal vital sign values for the following variables: Blood pressure (sitting) and Pulse rate (sitting), as judged by the investigator

4. Secondary Outcome Measure: Number of patients with abnormal plasma cortisol values. [ Time Frame: 54 weeks ]

Measure Type	Secondary
Measure Name	Number of patients with abnormal plasma cortisol values.
Measure Description	Cut-off value of cortisol is defined as 4 mcg/dL.
Time Frame	54 weeks
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.

Reporting Groups

	Description
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Measured Values

	Budesonide	Conventional Therapy
Number of Participants Analyzed [units:participants]	121	120
Number of patients with abnormal plasma cortisol values. [units: Participants]	20	12

No statistical analysis provided for Number of patients with abnormal plasma cortisol values.

5. Secondary Outcome Measure: Height [ Time Frame: Baseline and 54 weeks ]

Measure Type	Secondary
Measure Name	Height
Measure Description	Height, change from baseline calculated as (height at last visit - height at randomization)
Time Frame	Baseline and 54 weeks
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.

Reporting Groups

	Description
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Measured Values

	Budesonide	Conventional Therapy
Number of Participants Analyzed [units:participants]	109	113
Height [units: Centimeters] Mean (Standard Deviation)	5.34 (1.99)	6.35 (1.89)

No statistical analysis provided for Height

6. Secondary Outcome Measure: Weight [ Time Frame: Baseline and 54 weeks ]

Measure Type	Secondary
Measure Name	Weight
Measure Description	Weight, change from baseline calculated as (weight at last visit - weight at randomization)
Time Frame	Baseline and 54 weeks
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.

Reporting Groups

	Description
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Measured Values

	Budesonide	Conventional Therapy
Number of Participants Analyzed [units:participants]	109	113
Weight [units: kilograms] Mean (Standard Deviation)	3.78 (2.77)	4.39 (3.22)

No statistical analysis provided for Weight

7. Secondary Outcome Measure: Morning Peak Expiratory Flow (PEF) percentage of predicted normal [ Time Frame: 54 weeks ]

Measure Type	Secondary
Measure Name	Morning Peak Expiratory Flow (PEF) percentage of predicted normal
Measure Description	Change in PEF percent of predicted normal calculated as (PEF percent predicted normal at last visit - PEF percent predicted normal at randomization).
Time Frame	54 weeks
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.

Reporting Groups

	Description
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Measured Values

	Budesonide	Conventional Therapy
Number of Participants Analyzed [units:participants]	121	120
Morning Peak Expiratory Flow (PEF) percentage of predicted normal [units: Percentage] Mean (Standard Deviation)	9.54 (19.87)	5.84 (17.81)

No statistical analysis provided for Morning Peak Expiratory Flow (PEF) percentage of predicted normal

8. Secondary Outcome Measure: Change from baseline of respiratory condition at asthma attacks (daytime) [ Time Frame: Baseline and 54 weeks ]

Measure Type	Secondary
Measure Name	Change from baseline of respiratory condition at asthma attacks (daytime)
Measure Description	Change in respiratory condition at asthma attacks (daytime) from baseline to last visit. Scale: 0 - 4. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency
Time Frame	Baseline and 54 weeks
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.

Reporting Groups

	Description
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Measured Values

	Budesonide	Conventional Therapy
Number of Participants Analyzed [units:participants]	121	119
Change from baseline of respiratory condition at asthma attacks (daytime) [units: Points on a scale] Mean (Standard Deviation)	-0.139 (0.334)	-0.156 (0.302)

No statistical analysis provided for Change from baseline of respiratory condition at asthma attacks (daytime)

9. Secondary Outcome Measure: Change from baseline of respiratory condition at asthma attacks (nighttime) [ Time Frame: Baseline and 54 weeks ]

Measure Type	Secondary
Measure Name	Change from baseline of respiratory condition at asthma attacks (nighttime)
Measure Description	Change in respiratory condition at asthma attacks (nighttime) from baseline calculated as (respiratory condition at asthma attacks (nighttime) at last visit - respiratory condition at asthma attacks (night-time) at randomization). Scale: 0 - 4. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency.
Time Frame	Baseline and 54 weeks
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.

Reporting Groups

	Description
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Measured Values

	Budesonide	Conventional Therapy
Number of Participants Analyzed [units:participants]	121	119
Change from baseline of respiratory condition at asthma attacks (nighttime) [units: Points on a scale] Mean (Standard Deviation)	-0.12 (0.29)	-0.147 (0.3)

No statistical analysis provided for Change from baseline of respiratory condition at asthma attacks (nighttime)

10. Secondary Outcome Measure: Change from baseline of use of inhaled short-acting B-2 agonist (daytime) [ Time Frame: Baseline and 54 weeks ]

Measure Type	Secondary
Measure Name	Change from baseline of use of inhaled short-acting B-2 agonist (daytime)
Measure Description	Change in use of inhaled short-acting B-2 agonist (daytime) from baseline calculated as (use of inhaled short-acting B-2 agonist (daytime) at last visit - use of inhaled short-acting B-2 agonist (daytime) at randomization)
Time Frame	Baseline and 54 weeks
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.

Reporting Groups

	Description
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Measured Values

	Budesonide	Conventional Therapy
Number of Participants Analyzed [units:participants]	121	119
Change from baseline of use of inhaled short-acting B-2 agonist (daytime) [units: Puffs per day] Mean (Standard Deviation)	-0.21 (0.647)	-0.242 (0.485)

No statistical analysis provided for Change from baseline of use of inhaled short-acting B-2 agonist (daytime)

11. Secondary Outcome Measure: Change from baseline of use of inhaled short-acting B-2 agonist (night-time) [ Time Frame: Baseline and 54 weeks ]

Measure Type	Secondary
Measure Name	Change from baseline of use of inhaled short-acting B-2 agonist (night-time)
Measure Description	Change in use of inhaled short-acting B-2 agonist (night-time) from baseline calculated as (use of inhaled short-acting B-2 agonist (night-time) at last visit - use of inhaled short-acting B-2 agonist (night-time) at randomization)
Time Frame	Baseline and 54 weeks
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.

Reporting Groups

	Description
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Measured Values

	Budesonide	Conventional Therapy
Number of Participants Analyzed [units:participants]	121	119
Change from baseline of use of inhaled short-acting B-2 agonist (night-time) [units: Puffs per day] Mean (Standard Deviation)	-0.07 (0.415)	-0.097 (0.368)

No statistical analysis provided for Change from baseline of use of inhaled short-acting B-2 agonist (night-time)

12. Secondary Outcome Measure: Change from baseline in disturbance of daily activities [ Time Frame: Baseline and 54 weeks ]

Measure Type	Secondary
Measure Name	Change from baseline in disturbance of daily activities
Measure Description	Change in disturbance of daily activities from baseline calculated as (disturbance of daily activities at last visit - disturbance of daily activities at randomization). Frequency of disturbance of daily activity was assessed using 3- grade scale (normal, almost able, unable).
Time Frame	Baseline and 54 weeks
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.

Reporting Groups

	Description
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Measured Values

	Budesonide	Conventional Therapy
Number of Participants Analyzed [units:participants]	121	119
Change from baseline in disturbance of daily activities [units: Disturbances per day] Mean (Standard Deviation)	-0.037 (0.141)	-0.017 (0.141)

No statistical analysis provided for Change from baseline in disturbance of daily activities

13. Secondary Outcome Measure: Change from baseline in disturbance of night-time sleep [ Time Frame: Baseline and 54 weeks ]

Measure Type	Secondary
Measure Name	Change from baseline in disturbance of night-time sleep
Measure Description	Change in disturbance of night-time sleep from baseline calculated as (disturbances of night-time sleep at last visit - disturbances of night-time sleep at randomization). Frequency of disturbance of night- time sleep was assessed using 3- grade scale (normal, almost able, unable).
Time Frame	Baseline and 54 weeks
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.

Reporting Groups

	Description
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Measured Values

	Budesonide	Conventional Therapy
Number of Participants Analyzed [units:participants]	121	119
Change from baseline in disturbance of night-time sleep [units: Disturbances per night] Mean (Standard Deviation)	-0.029 (0.134)	-0.042 (0.132)

No statistical analysis provided for Change from baseline in disturbance of night-time sleep

14. Secondary Outcome Measure: Forced Expiratory Volume in one second (FEV1) percentage of predicted normal change from baseline [ Time Frame: 54 weeks ]

Measure Type	Secondary
Measure Name	Forced Expiratory Volume in one second (FEV1) percentage of predicted normal change from baseline
Measure Description	Forced Expiratory Volume in one second (FEV1) percentage of predicted normal change from baseline calculated as: 100 * (FEV1 at last visit - FEV1 at randomization)/predicted normal FEV1).
Time Frame	54 weeks
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.

Reporting Groups

	Description
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Measured Values

	Budesonide	Conventional Therapy
Number of Participants Analyzed [units:participants]	121	120
Forced Expiratory Volume in one second (FEV1) percentage of predicted normal change from baseline [units: Percentage] Mean (Standard Deviation)	1.5 (15.59)	2.31 (16.63)

No statistical analysis provided for Forced Expiratory Volume in one second (FEV1) percentage of predicted normal change from baseline

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Serious Adverse Events

Budesonide

Conventional Therapy

Total, serious adverse events

# participants affected / at risk

10/121 (8.26%)

11/120 (9.17%)

Respiratory, thoracic and mediastinal disorders

Asthma¹,^†

# participants affected / at risk

5/121 (4.13%)

6/120 (5.00%)

Infections and infestations

Adenoviral conjunctivitis¹,^†

# participants affected / at risk

1/121 (0.83%)

0/120 (0.00%)

Infections and infestations

Appendicitis¹,^†

# participants affected / at risk

1/121 (0.83%)

0/120 (0.00%)

Infections and infestations

Gastroenteritis¹,^†

# participants affected / at risk

1/121 (0.83%)

0/120 (0.00%)

Infections and infestations

Influenza¹,^†

# participants affected / at risk

1/121 (0.83%)

0/120 (0.00%)

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

1/121 (0.83%)

2/120 (1.67%)

Injury, poisoning and procedural complications

Tibia fracture¹,^†

# participants affected / at risk

1/121 (0.83%)

0/120 (0.00%)

Infections and infestations

Enterocolitis bacterial¹,^†

# participants affected / at risk

1/121 (0.83%)

0/120 (0.00%)

Gastrointestinal disorders

Abdominal pain¹,^†

# participants affected / at risk

0/121 (0.00%)

1/120 (0.83%)

Respiratory, thoracic and mediastinal disorders

Bronchitis¹,^†

# participants affected / at risk

0/121 (0.00%)

3/120 (2.50%)

Infections and infestations

Gastroenteritis rotavirus¹,^†

# participants affected / at risk

0/121 (0.00%)

1/120 (0.83%)

Vascular disorders

Hypotension¹,^†

# participants affected / at risk

0/121 (0.00%)

1/120 (0.83%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 11.0
2	Term from vocabulary,

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
Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
Conventional Therapy	According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Other Adverse Events

Budesonide

Conventional Therapy

Total, other (not including serious) adverse events

# participants affected / at risk

100/121 (82.64%)

113/120 (94.17%)

Eye disorders

Conjunctivitis Allergic¹,^†

# participants affected / at risk

15/121 (12.40%)

20/120 (16.67%)

Infections and infestations

Upper Respiratory Tract Infection¹,^†

# participants affected / at risk

68/121 (56.20%)

60/120 (50.00%)

Infections and infestations

Bronchitis¹,^†

# participants affected / at risk

40/121 (33.06%)

46/120 (38.33%)

Infections and infestations

Pharyngitis¹,^†

# participants affected / at risk

36/121 (29.75%)

40/120 (33.33%)

Infections and infestations

Gastroenteritis¹,^†

# participants affected / at risk

28/121 (23.14%)

30/120 (25.00%)

Infections and infestations

Influenza¹,^†

# participants affected / at risk

30/121 (24.79%)

27/120 (22.50%)

Infections and infestations

Nasopharyngitis¹,^†

# participants affected / at risk

23/121 (19.01%)

21/120 (17.50%)

Infections and infestations

Otitis Media¹,^†

# participants affected / at risk

15/121 (12.40%)

15/120 (12.50%)

Infections and infestations

Chronic Sinusitis¹,^†

# participants affected / at risk

14/121 (11.57%)

10/120 (8.33%)

Infections and infestations

Acute Tonsillitis¹,^†

# participants affected / at risk

10/121 (8.26%)

9/120 (7.50%)

Infections and infestations

Impetigo¹,^†

# participants affected / at risk

8/121 (6.61%)

9/120 (7.50%)

Infections and infestations

Hordeolum¹,^†

# participants affected / at risk

0/121 (0.00%)

6/120 (5.00%)

Injury, poisoning and procedural complications

Contusion¹,^†

# participants affected / at risk

8/121 (6.61%)

9/120 (7.50%)

Nervous system disorders

Headache¹,^†

# participants affected / at risk

10/121 (8.26%)

11/120 (9.17%)

Respiratory, thoracic and mediastinal disorders

Rhinitis Allergic¹,^†

# participants affected / at risk

26/121 (21.49%)

22/120 (18.33%)

Skin and subcutaneous tissue disorders

Eczema¹,^†

# participants affected / at risk

11/121 (9.09%)

16/120 (13.33%)

Skin and subcutaneous tissue disorders

Urticaria¹,^†

# participants affected / at risk

10/121 (8.26%)

12/120 (10.00%)

Skin and subcutaneous tissue disorders

Dermatitis Atopic¹,^†

# participants affected / at risk

6/121 (4.96%)

6/120 (5.00%)

Skin and subcutaneous tissue disorders

Dry Skin¹,^†

# participants affected / at risk

2/121 (1.65%)

6/120 (5.00%)

Skin and subcutaneous tissue disorders

Heat Rash¹,^†

# participants affected / at risk

3/121 (2.48%)

6/120 (5.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 11.0
2	Term from vocabulary,

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:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description:

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]

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=377&filename=CSR-D5254C00006.pdf
Download
CSR-D5254C00006.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Yoko Ueda

+81-6-6453-7943

Yoko.Ueda@astrazeneca.com

Contact Backup

Public Information

+81-6-6453-8011

Investigators

Principal Investigator

Lars-Goran Carlsson

AstraZeneca R&D Lund

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=377&filename=CSR-D5254C00006.pdf

CSR-D5254C00006.pdf

Trial Results Summaries