New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day

Phase 3

Completed

Brief Summary: This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.

Recruitment & Eligibility

Inclusion Criteria

Male or female 12 years and above
Clinical diagnosis of asthma according to the American Thoracic Society definition at least 6 months
Pre-bronchodilator FEV1 ≥ 45% and ≤ 85% of predicted normal
Patients with reversible airway obstruction
Documented daily use of inhaled corticosteroids for ≥ 3 months

Exclusion Criteria

History of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures during the 2 years prior to Visit 2
Hospitalized during previous 6 months for asthma
Required emergency treatment more than once during previous 6 months for an asthma-related condition
Intake of oral, rectal or parenteral glucocorticosteroid within 30 days of enrolment
Respiratory infection affecting the asthma within 30 days

Arm && Interventions

Group	Intervention	Description
Symbicort/inhaler	Symbicort	Symbicort AC pDMI 2x160/4.5 μg twice daily
1 Symbicort/inhaler	Symbicort	Symbicort BA MDI 2x160/4.5 μg twice daily
Budesonide/inhaler	Budesonide	Budesonide AC pMDI 2x160 μg twice daily

Primary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in 1 Second (FEV1) - Post Dose	60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg	Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose	Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg	Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.

Secondary Outcome Measures

Name	Time	Method
Peak Expiratory Flow	Recorded morning upon rising and evening before sleep for 14 weeks
Asthma Symptoms Score (Total)	Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks	The total score is calculated as sum of the morning and evening scores of each day and the treatment period mean score is defined as the mean of all total score recorded during the 12-week treatment period. Trt Avg=Mean total score of double-blind period values.(day/night score ranges from 0 to 3; 0=no asthma symptoms; 3= unable to do normal activities (or to sleep) due to asthma). Higher score represents worse outcome.
Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights)	Recorded 6:00 - 11:00 AM for 14 weeks	The percentage of days with no awakenings due to asthma. Baseline= Mean % awakening-free nights during run-in period ; Trt Avg=Mean % awakening-free nights during double-blind period.
Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use)	Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks	Total daily rescue medication use is calculated as the sum of morning and evening use each day and averaged over the 12 weeks treatment periods to calculate the treatment period mean. Baseline= Mean rescue medication used during run-in period ; Trt Avg=Mean rescue medication used during double-blind period.