A Phase II, Multicentre, Double-blind, Randomised, 5-way Crossover Study to Test the Non-inferiority of the Acute Bronchodilator Effect of CHF 1535 200/6 µg NEXThaler Versus CHF 1535 100/6 µg NEXThaler in Partially Controlled and Uncontrolled Adult Asthmatic Patients.
Overview
- Phase
- Phase 2
- Intervention
- Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg
- Conditions
- Asthma
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- FEV1 Area under the curve
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator effect between a single dose of CHF 1535 NEXThaler 200/6 µg and a single dose of CHF 1535 NEXThaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient's written informed consent obtained prior to any study-related procedures.
- •Male or female aged between 18 and 65 years inclusive;
- •Evidence for "partially controlled" or "uncontrolled" asthma;
- •Medium daily dose of previous inhaled corticosteroids (ICS) treatment;
- •FEV1 between 60% and 85% of the predicted normal values;
- •A documented positive response to the reversibility test;
- •Non-smokers or ex-smokers;
- •A cooperative attitude and ability to be trained in the proper use of a DPI.
Exclusion Criteria
- •Pregnant or lactating women and all women physiologically capable of becoming pregnant not willing to use at least one acceptable method of contraception.
- •Significant seasonal variation in asthma occurring or expected to occur during study participation;
- •History of near fatal asthma, brittle asthma, accident and Emergency treatment or hospitalisation for asthma exacerbation in Intensive Care Unit within 1 year before screening;
- •Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening;
- •Diagnosis of Chronic Obstructive Pulmonary Disease;
- •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 8 weeks;
- •Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids;
- •Allergy, sensitivity or intolerance to study drugs or excipients;
Arms & Interventions
CHF1535 NEXThaler 100/6, 1 puff
Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg
Intervention: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg
CHF1535 NEXThaler 100/6 µg, 4 puffs
Beclometasone Dipropionate 400 µg + Formoterol Fumarate 24 µg
Intervention: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg
CHF1535 NEXThaler 200/6 µg, 1 puff
Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg
Intervention: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg
CHF1535 NEXThaler 200/6 µg, 4 puffs
Beclometasone Dipropionate 800 µg + Formoterol Fumarate 24 µg
Intervention: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg
Placebo NEXThaler
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
FEV1 Area under the curve
Time Frame: until 12 h post dose
FEV1= Forced expiratory volume in the first second of expiration
Secondary Outcomes
- FEV1 peak(until 12 h post dose)
- FVC area under the curve(until 12 h post dose)
- FVC peak(until 12 h post dose)
- Adverse events(over a period of 5 to 14 weeks)