Symbicort Rapihaler Therapeutic Equivalence Study

Phase 3

Completed

Conditions: Bronchial Asthma

Interventions: Drug: Pulmicort Turbuhaler
Drug: Symbicort pMDI
Drug: Symbicort Turbuhaler

Registration Number: NCT00536731

Lead Sponsor: AstraZeneca

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 742

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmicort Turbuhaler	Pulmicort Turbuhaler	Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
Symbicort pMDI	Symbicort pMDI	Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
Symbicort Turbuhaler	Symbicort Turbuhaler	Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily

Primary Outcome Measures

Name	Time	Method
Morning Peak Expiratory Flow (PEF)	Baseline to 6 weeks	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

Secondary Outcome Measures

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