Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients
Study Details
Study Description
Brief Summary
The purpose of this study is to show the superiority of CHF 1535 (BDP/FF) pMDI over BDP HFA pMDI in terms of lung function considering change from baseline to the entire treatment period in average pre-dose morning PEF in adult asthmatic patients not adequately controlled on high doses of ICS or on medium dose of ICS+LABA.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CHF 1535 200/6µg
|
Drug: CHF1535 200/6 µg
CHF 1535 (BDP/FF) 800/24 µg daily during 12 weeks
|
| Active Comparator: BDP 100µg
|
Drug: BDP 100 µg
Beclomethasone Dipropionate 800µg daily during 12 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pre-dose morning PEF [12 weeks]
Change from baseline to the entire treatment period in average pre-dose morning PEF
Secondary Outcome Measures
- Pre-dose morning FEV1 [2 weeks]
Change from baseline in pre-dose morning FEV1 every two weeks over a 12-week period
- Asthma symptoms [12 weeks]
Asthma symptoms collected day and night-time
- Adverse Events [14 weeks]
Adverse Events
Eligibility Criteria
Criteria
Main Inclusion Criteria:
-
Male or female patients aged > 18 years.
-
Patients with persistent asthma not optimally controlled (GINA 2010) on high doses of ICS or medium dose of ICS+LABA at a stable dose for at least 4 weeks prior to screening.
-
Patients with FEV1 >= 40% and < 80% of predicted for the patient normal value and at least 0.9 L.
-
Patients with 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.
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At screening and at the end of the run-in period, patients with not adequately controlled asthma according to GINA 2010 and with score at the Asthma Control Questionnaire (ACQ)> 0.75
Main Exclusion Criteria:
-
History of near fatal asthma or of a past hospitalisation for asthma in Intensive Care Unit or of frequent exacerbations (3 or more asthma exacerbations/ year).
-
Hospitalisation, Emergency Room admission or use of systemic steroids (more than 3 days) for asthma exacerbation in the 4 weeks prior to screening visit and during the run-in period.
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Symptomatic infection of the lower airways in the 4 weeks before the screening visit.
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Current or ex-smokers with total cumulative exposure equal or more than 5 pack-years and /or having stopped smoking one year or less prior to screening visit.
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Patients with a clinically significant abnormality at 12-lead ECG or presenting a QTcB interval value in ECG > 450 msec in males or > 470 msec in females).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cardio-Thoracic and Vascular Dept, University of Pisa | Pisa | Italy | 56124 |
Sponsors and Collaborators
- Chiesi Farmaceutici S.p.A.
Investigators
- Principal Investigator: Pierluigi Paggiaro, MD, PhD, Cardio-Thoracic and Vascular Dept, University of Pisa
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Study Record on EU Clinical Trials Register including results
- CSR Synopsis available in the CHIESI Clinical Study Register
Publications
None provided.- CCD-1005-PR-0040
- 2010-020602-14