Asthma
Conditions
Brief 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.
Detailed description
The primary objective is to demonstrate that CHF 1535 NEXT DPI® (beclomethasone dipropionate + formoterol fumarate 100/6 μg), 1 inhalation twice daily, is non-inferior to the corresponding dose of CHF 1535 pMDI in terms of pulmonary function test (change from baseline to the entire treatment period in average pre-dose morning PEF) in asthmatic adult patients ≥ 18 years under treatment with fixed dose combination of Foster® (beclomethasone dipropionate + formoterol fumarate 100 / 6 μg) 1 inhalation bid.
Interventions
DRUGCHF 1535 100/6 NEXT DPI® 2 months
CHF 1535 100/6 NEXT DPI® 2 months
DRUGCHF 1535 100/6 pMDI 2 months
CHF 1535 100/6 pMDI 2 months
DRUGBDP DPI 2 months
BDP DPI 2 months
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female adults (≥18 years old). 2. Reversibility test defined as ΔFEV1 ≥ 12% and ≥ 200 mL . 3. FEV1 \> 80% of the predicted values . 4. Asthma Control Questionnaire score \< 1.25. 5. Asthmatic patients 6. Non- or ex-smokers
Exclusion criteria
1. History of near fatal asthma. 2. COPD patients 3. Asthma exacerbation within 1 month prior to the screening visit or asthma exacerbation during the run-in period. 4. Lower respiratory tract infection within 1 month prior Visit1 (V1). 5. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency. 6. Diagnosis of restrictive lung disease. 7. Patients treated with oral or parenteral corticosteroids in the previous 2 months before V1 8. Intolerance or contra-indication to treatment with beta 2-agonists and/or inhaled corticosteroids or allergy to any component of the study treatments. 9. Significant medical history of and/or treatments 10. Active cancer or a history of cancer .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the entire treatment period in average pre-dose morning Peak Expiratory Flow. | at 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pre-dose morning FVC (Force Vital Capacity) ; | at 2, 4, 6 and 8 weeks of treatment |
| ACQ (Asthma Control Questionnaire) score ; | at eight weeks |
| pre-dose evening PEF ; | at 2, 4, 6 and 8 weeks of treatment |
| Pre-dose morning FEV1 (Forced Expiratory Volume in one second); | at 2, 4, 6 and 8 weeks of treatment |
| use of rescue medication ; | at 2, 4, 6 and 8 weeks of treatment |
| percentage of rescue use-free days | at 2, 4, 6 and 8 weeks of treatment |
| pre-dose morning PEF ; | at 2, 4, 6 and 8 weeks of treatment |
| daily PEF variability ; | at 2, 4, 6 and 8 weeks of treatment |
Countries
Poland
Outcome results
None listed