Efficacy of CHF1535 Via NEXT DPI Versus pMDI and BDP DPI100µg on PeakExpiratoryFlow in Asthmatic Patients

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone

Criteria

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 .