Symbicort Rapihaler Therapeutic Equivalence Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bronchial Asthma

Intervention / Treatment
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* Drug: Symbicort Turbuhaler
* Drug: Symbicort pMDI
* Drug: Pulmicort Turbuhaler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asthma clinically diagnosed since at least 6 months. Lung function values measured ≥ 50% and ≤ 90% of predicted normal. Patients with reversible airway obstruction Daily use of inhaled steroids (any brand) for >3 months. Exclusion Criteria: Use of oral, rectal or parenteral steroids within 30 days prior to start of study. Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to start of randomised treatment. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Symbicort pMDI<br>Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily | Drug: Symbicort pMDI<br>* Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily<br>|
| Active Comparator: Symbicort Turbuhaler<br>Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily | Drug: Symbicort Turbuhaler<br>* Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily<br>|
| Active Comparator: Pulmicort Turbuhaler<br>Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily | Drug: Pulmicort Turbuhaler<br>* Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morning Peak Expiratory Flow (PEF) | 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 | Baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evening 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 | Baseline to 6 weeks | 
| Asthma Symptom Score, Night | 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. | Baseline to 6 weeks | 
| Asthma Symptom Score, Day | 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. | Baseline to 6 weeks | 
| Asthma Symptom Score, Total | 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. | Baseline to 6 weeks | 
| Percentage of Nights With Awakenings Due to Asthma | 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. | Baseline and 6 weeks | 
| Use of Rescue Medication, Night | 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 | Baseline to 6 weeks | 
| Use of Rescue Medication, Day | 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 | Baseline to 6 weeks | 
| Use of Rescue Medication, Total | 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 | Baseline to 6 weeks | 
| Percentage of Symptom-free Days | 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. | Baseline to 6 weeks | 
| Percentage of Asthma Control 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. | Baseline to 6 weeks | 
| Percentage of Rescue Free 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. | Baseline to 6 weeks | 
| Forced Expiratory Volume in 1 Second (FEV1) | Change in the FEV1from baseline to week 6 (calculated as a mean using all available data after randomization) | Baseline to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Symbicort