Efficacy of CHF1535 Via NEXT DPI Versus pMDI and BDP DPI100µg on PeakExpiratoryFlow in Asthmatic Patients
Study Identifier:
CCD-1009-PR-0050
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Asthma
Study Drug
- Drug: CHF 1535 100/6 NEXT DPI® 2 months
- Drug: CHF 1535 100/6 pMDI 2 months
- Drug: BDP DPI 2 months
Date
Mar 2011 - Aug 2011
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Male and female adults (≥18 years old).
- Reversibility test defined as ΔFEV1 ≥ 12% and ≥ 200 mL .
- FEV1 \> 80% of the predicted values .
- Asthma Control Questionnaire score \< 1.25.
- Asthmatic patients
- Non- or ex-smokers
Exclusion Criteria
- History of near fatal asthma.
- COPD patients
- Asthma exacerbation within 1 month prior to the screening visit or asthma exacerbation during the run-in period.
- Lower respiratory tract infection within 1 month prior Visit1 (V1).
- History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
- Diagnosis of restrictive lung disease.
- Patients treated with oral or parenteral corticosteroids in the previous 2 months before V1
- Intolerance or contra-indication to treatment with beta 2-agonists and/or inhaled corticosteroids or allergy to any component of the study treatments.
- Significant medical history of and/or treatments
- Active cancer or a history of cancer .
Healthy Volunteers
No
Protocol Summary
The purpose of this study is to demonstrate that CHF 1535 NEXT DPI® is non-inferior to the corresponding dose of CHF 1535 pMDI and superior to marketed beclomethasone DPI 100 µg in terms of average pre-dose morning Peak Expiratory Flow (PEF) in asthmatic adult patients.
Study Locations
Location
Status
Location
GSPZOZ Uniwersytecki Szpital Kliniczny
Lodz, Poland, 90-153
Status
N/A