A 24-week, multicenter, multinational, randomized, double-blind, triple-dummy, 3-arm parallel group study comparing the efficacy and safety of CHF 1535 200/6 (beclomethasone dipropionate 200 g plus formoterol 6 g/actuation), 2 puffs b.i.d., versus beclomethasone diproprionate HFA (250 g/actuation), 4 puffs b.i.d., versus Seretide 500/50 (fluticasone 500 g plus salmeterol 50 g/actuation), 1 inhalation b.i.d., in patients with severe asthm - CCD-0605-PR-0021
- Conditions
- severe asthmaMedDRA version: 6.1Level: PTClassification code 10003553
- Registration Number
- EUCTR2007-002587-99-IT
- Lead Sponsor
- CHIESI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1050
1. Subject?s written informed consent and written informed consent by parents/legal representatives (adolescent patients). 2. Outpatients of both sexes aged 12 and 70 years. 3. Evidence of asthma demonstrated by a documented positive response to the reversibility test, defined as ΔFEV1 > 12% and > 200 mL over baseline, within 30 minutes after administration of 400 μg of salbutamol pMDI. In case this is not achieved, a historically documented FEV1 reversibility within the previous 12 months is acceptable. 4. Patients with severe persistent asthma diagnosed according to GINA guidelines (revised 2006).
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patient will not be enrolled at Visit 1 into the run-in period and will not be randomized to treatment at Visit 2 (i.e. these criteria will be also reviewed at Visit 2) if they meet one or more of the following criteria: 1. Pregnant or lactating women. Females of childbearing potential without an efficient contraception (e.g. oestro-progestatives, condoms). 2. Having received an investigational drug within 2 months. 3. Inability to comply with study procedures or with study treatment intake. 4. Seasonal asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer. 5. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method