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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

Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed

Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed

The primary objective of this study is to compare the efficacy of Symbicort SMART  (Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy

Study to investigate the efficacy of Symbicort® SMART.

Research Site

A comparison of Symbicort® SMART (160/4.5μg) and Symbicort® Turbuhaler 160/4.5 μg, plus terbutaline Turbuhaler 0.4 mg as needed, for treatment of asthma - a 12-month, randomized, double-blind, parallel group, active-controlled, multinational phase III study in asthmatic patients from 16 years

Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid [GCS] treatment, hospitalization, or emergency room [ER] treatment.

Age Continuous

Gender, Male/Female

The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9
guideline.

The percentage of participants who had experienced asthma exacerbation(s) at the end of the study

Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here.

Number of asthma exacerbations

The mean value from a 52-week treatment period.

Morning Peak Expiratory Flow (PEF)

Evening PEF

The mean value for Weeks 4, 12, 24, 36 and 52 was analysed.

Forced expiratory volume in one second (FEV1)

The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time).

Use of as-needed medication

The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst).

Asthma symptom score

The mean value from the treatment period was presented here.

Nights With Awakening(s) Due to Asthma Symptoms

Mild asthma exacerbation was defined as morning PEF ≥20% below baseline, daily as-needed medication use ≥2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here.

The Percentage of Participants Who Had Experienced first mild asthma exacerbations

A symptom-free day was defined as a day without daytime or night-time symptoms and without night-time awakenings due to asthma symptoms. The mean value was presented here.

Symptom-free days (no symptoms and no awakenings)

An as-needed-free day is defined as a night and day with no use of as-needed medication. The mean value from the treatment period was presented here.

Percentage of as-needed-free Days

An asthma-control day was defined as a a night and day with no asthma symptoms, no awakenings due to asthma symptoms, and no as-needed medication use. The mean value from the treatment period was presented here.

Percentage of asthma-control days (no asthma symptoms, no awakenings, and no as-needed use)

The ACQ developed by Juniper and colleagues (Juniper et al 1999) was used without the FEV1 and Beta 2-agonist questions. The Asthma Control Questionnaire has 5 questions that are assessed on a 7-point scale from 0 to 6 where 0 represents good control and 6 represents poor control. The overall score is the mean of the five responses. At least 4 out of the 5 questions must have been answered to provide a value. The mean of the overall score for Weeks 4 to 52  was presented here.

Asthma Control Questionnaire (ACQ)

Overall Study

The study started with an enrolment visit, Visit 1, 1-7 days prior to Visit 2 (run-in). At Visit 2 patients had to have a reversibility of ≥12% relative to baseline and their pre-bronchodilatory Forced expiratory volume in one second (FEV1) had to be ≥50% of the predicted normal value.

Arms	Assigned Interventions
Experimental: 1 Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed	Drug: Symbicort Turbuhaler 160/4.5 µg
Active Comparator: 2 Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed	Drug: Symbicort Turbuhaler 160/4.5 µg Drug: Terbutaline Turbuhaler 0.4 mg

Study to investigate the efficacy of Symbicort® SMART. - SAKURA

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=399&filename=CSR-D589LC00001.pdf

CSR-D589LC00001.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator