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

Chiesi Farmaceutici S.p.A.932 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

932

Conditions

Asthma

Interventions

CHF 1535 100/6 NEXT DPI® 2 monthsDRUG

CHF 1535 100/6 NEXT DPI® 2 months

CHF 1535 100/6 pMDI 2 monthsDRUG

CHF 1535 100/6 pMDI 2 months

BDP DPI 2 monthsDRUG

BDP DPI 2 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 .

Locations (1)

GSPZOZ Uniwersytecki Szpital Kliniczny

Lodz, Poland

Outcomes

Primary Outcomes

Change from baseline to the entire treatment period in average pre-dose morning Peak Expiratory Flow.

Time frame: at 8 weeks