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

Conditions: Asthma
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2011-002523-17-HU

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 310

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
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 283
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

History of life-threatening asthma
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 enrollment
Respiratory infection affecting asthma within 30 days

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Compare efficacy of Symbicort BA MDI with that of Symbicort AC pMDI by evaluation of FEV1, 60 minutes post-dose and pre-dose.;Secondary Objective: Assess patient-reported functionality of the Symbicort BA MDI device in a clinical setting.;Primary end point(s): Forced expiratory volume in 1 second (FEV1)<br>;Timepoint(s) of evaluation of this end point: FEV1 - Pre AM dose in clinic visits at baseline and week 3, 7 and 12;<br>FEV1 - 60 minutes post-dose in clinic visits at baseline and week 3, 7 and 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Peak expiratory flow;<br>Asthma symptoms and use of rescue medications;<br>Night-time awakenings due to asthma symptoms;Timepoint(s) of evaluation of this end point: Peak expiratory flow - Recorded morning upon rising and evening before sleep for 14 weeks;<br>Asthma symptoms and use of rescue medications - Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 - 11:00 PM from previous 12 hours for 14 weeks<br>Night-time awakenings due to asthma symptoms - Recorded 6:00 - 11:00 AM for 14 weeks