adult patients with uncontrolled asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: Beclomethasone+salbutamol
Product Code: CHF 1530 HFA
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: Salbutamol and other drugs for obstructive airway diseas
Sponsors
CHIESI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained, 2. Male or female out-patients aged ? 18 and twice a week; b) any limitation of activities; c) any nocturnal symptoms/awakening; b) need for reliever/rescue treatment > twice a week. These conditions are to be based on recent medical history and are to be confirmed in the 2-week run-in period;4. Forced expiratory volume in the first second (FEV1) ? 60% and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Inability to carry out pulmonary function testing;2. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the National Heart Lung and Blood Institute/World Health Organisation (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines updated 2006;3. History of near fatal asthma;4. Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks;5. Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months;6. Patients who have been treated with an inhaled corticosteroid in the previous 4 weeks;7. Patients who have been treated with nebulized, oral, intravenous or intramuscular corticosteroids in the past 8 weeks or depot injectable corticosteroids in the past 12 weeks;8. Patients who have been treated with a long-acting β2-agonist (LABA) in the past 2 weeks;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate that the test treatment BDP 250 mcg/salbutamol 100 mcg HFA pMDI fixed combination is non-inferior to BDP 250 mcg/salbutamol 100 mcg pMDI fixed combination given with the conventional CFC propellant (Clenil Compositum 250, Chiesi Farmaceutici) in terms of Pulmonary Function (morning PEF);Secondary Objective: To assess the efficacy of the two investigational study drugs on pulmonary function parameters, asthma symptoms, use of relief medications and frequency of asthma exacerbations;? To assess the safety of the two investigational study drugs as regards frequency of adverse events, laboratory parameters (potassium, glucose, 12-hour overnight cortisol/creatinine ratio), ECG (with QTc interval) and vital signs (heart rate and blood pressure).;Primary end point(s): The primary efficacy variable is the mean value of morning PEF (daily measured by the patient using the Piko-1 peak flow meter (Qubisoft, Italy) in weeks 11-12. | — |
Countries
Italy, Spain
Outcome results
None listed