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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®pMDI® 40/2.25 μg 2 Actuations Twice Daily

Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily

Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily

The purpose of  the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.

Symbicort Rapihaler Therapeutic Equivalence study

Research Site

A 6-week, phase III, double-blind, randomized, multi-centre, parallel-group study evaluating the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with 1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily

Change in the Morning PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed

Age Continuous

Gender, Male/Female

Morning Peak Expiratory Flow (PEF)

Change in the Evening PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed

Evening Peak Expiratory Flow (PEF)

Change in the Asthma Symptom Score (Night) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.

Asthma Symptom Score, Night

Change in the Asthma Symptom Score (Day) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.

Asthma Symptom Score, Day

Change in the Asthma Symptom Score (Total) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.

Asthma Symptom Score, Total

Change in the Percentage of Nights With Awakenings Due to Asthma from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. The participants answered "Yes" or "No" whether she/he woke up during the night due to asthma.

Percentage of Nights With Awakenings Due to Asthma

Change in the Use of Rescue Medication (Night) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed

Use of Rescue Medication, Night

Change in the Use of Rescue Medication (Day) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed

Use of Rescue Medication, Day

Change in the Use of Rescue Medication (Total) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed

Use of Rescue Medication, Total

Change in the Percentage of Symptom-free Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Symptom-free Day: no symptoms (asthma symptom score=0) night and day, and no awakenings due to asthma.

Percentage of Symptom-free Days

Change in the Percentage of Symptom Control Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Asthma Control Day: no symptoms (asthma symptom score=0) night and day, no awakenings due to asthma, no rescue medication.

Percentage of Asthma Control Days

Change in the Percentage of Rescue Free Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Rescue-free Day defined as day and night with no use of rescue medication.

Percentage of Rescue free Days

Change in the FEV1from baseline to week 6 (calculated as a mean using all available data after randomization)

Arms	Assigned Interventions
Active Comparator: Symbicort pMDI Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily	Drug: Symbicort pMDI Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
Active Comparator: Symbicort Turbuhaler Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily	Drug: Symbicort Turbuhaler Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
Active Comparator: Pulmicort Turbuhaler Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily	Drug: Pulmicort Turbuhaler Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily

Symbicort Rapihaler Therapeutic Equivalence study - ESTHER

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=392&filename=CSR-D5897C00003.pdf

CSR-D5897C00003.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator