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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.

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Official Title

The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.

Investigation of efficacy, safety and tolerability of once and twice daily doses of AZD1981 in asthmatic patients

Research Site

A double-blind, placebo-controlled, randomised, parallel-group, phase II, multi-centre study to assess the efficacy, safety and tolerability of 4 twice daily doses and 2 once daily doses of  AZD1981 given as tablets during 12 weeks in asthmatic patients

Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.

Age Continuous

Gender, Male/Female

Race, Customized

Time since asthma diagnosis

Study Specific Characteristic

Smoking status

Pre-bronchodilator FEV1 percentage of predicted normal (PN) at randomization

Total daily dose of inhaled glucocorticosteroids (ICS)

Three patients (1 in the AZD1981 40 mg bid group and 2 in the placebo group) randomized at a Japanese centre were excluded from the analyses due to Good Clinical Practice violations identified after study completion.

The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint

Pre-bronchodilator FEV1 at the clinic

Morning PEF

Evening PEF

Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available morning (evening) PEF during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.

Morning and Evening PEF

The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. The minimal important difference is defined as a change in score of 0.5. Change from baseline: treatment period average minus baseline.

Asthma Control Questionnaire 5-item (ACQ5)

Number of participants who had at least one adverse event during the randomized treatment period

All randomized participants who received at least one dose of study medication and from whom any data after randomization was available

Adverse events

Severe asthma exacerbation defined as deterioration in asthma leading to either hospitalization/emergency room treatment or oral glucocorticosteroid treatment for at least 3 days

Number of participants with at least one severe asthma exacerbation

Treatment failure is defined as a clinical need for additional inhaled corticosteroid use as judged by the investigator based on evaluations at the clinic.

Number of participants with at least one treatment failure

The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. Well-controlled asthma is defined as ACQ5<=0.75 at the end of the 12-week treatment period.

Number of participants with well-controlled asthma (ACQ5<=0.75)

The AQLQ(S) consists of 32 questions, each assessed on a scale from 1-7, with higher values indicating better health-related quality of life. Overall scores are calculated from the means of the individual scores. The minimal important difference is a change in score of 0.5. Change from baseline: treatment period average minus baseline.

Asthma Quality of Life Questionnaire (AQLQ(S))

Asthma symptoms, measured in the morning and evening, based on a scale from 0-3 with higher scores indicating more severe asthma symptoms. Total asthma symptom score (0-6) is calculated by taking the sum of the morning and evening scores. Change from baseline: treatment period average minus baseline.

Asthma symptom score

Reliever medication use (number of inhalations), measured in the morning and evening. Total reliever medication use is calculated by taking the sum of the number of daytime and evening inhalations of reliever medication. Change from baseline: treatment period average minus baseline.

Total reliever medication use

Overall Study

Participants were screened for a period of 31 days out of which 17 days for enrollment and 2 weeks for run-in period.

Alison Holt 

Asthma symptoms, measured in the morning and evening, based on a scale from 0-3 with higher scores indicating more severe asthma symptoms. Total asthma symptom score is calculated by taking the sum of the morning and evening scores. Change from baseline: treatment period average minus baseline.

Arms	Assigned Interventions
Experimental: AZD1981 10 mg AZD1981 10 mg	Drug: AZD1981 AZD1981 twice daily
Experimental: AZD1981 40 mg AZD1981 40 mg	Drug: AZD1981 AZD1981 twice daily
Experimental: AZD1981 100 mg AZD1981 100 mg	Drug: AZD1981 AZD1981 twice daily
Experimental: AZD1981 400 mg AZD1981 400 mg	Drug: AZD1981 AZD1981 twice daily
Experimental: AZD1981 80 mg AZD1981 80 mg	Drug: AZD1981 AZD1981 once daily
Experimental: AZD1981 200 mg AZD1981 200 mg	Drug: AZD1981 AZD1981 once daily
Placebo Comparator: Placebo	Drug: Placebo Placebo to match AZD1981

Investigation of efficacy, safety and tolerability of once and twice daily doses of AZD1981 in asthmatic patients - Sweapea

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=716&filename=CSR-D9830C00008.pdf

CSR-D9830C00008.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator