A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Asthma

Intervention / Treatment
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* Drug: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg
* Drug: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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; Patients who received any investigational drug within the last 8 weeks before the screening; Patients taking any of the non-permitted concomitant medication; Subjects unlikely to comply with the study protocol; Any clinically relevant abnormal value or physical finding at screening; Significant medical history; Abnormal and clinically significant 12-lead electrocardiogram; Patients with low compliance of QVAR intake.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CHF1535 NEXThaler 100/6, 1 puff<br>Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg | Drug: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg<br> <br> * Other names: Foster NEXThaler;|
| Active Comparator: CHF1535 NEXThaler 100/6 µg, 4 puffs<br>Beclometasone Dipropionate 400 µg + Formoterol Fumarate 24 µg | Drug: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg<br> <br> * Other names: Foster NEXThaler;|
| Experimental: CHF1535 NEXThaler 200/6 µg, 1 puff<br>Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg | Drug: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg<br> <br> |
| Experimental: CHF1535 NEXThaler 200/6 µg, 4 puffs<br>Beclometasone Dipropionate 800 µg + Formoterol Fumarate 24 µg | Drug: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg<br> <br> |
| Placebo Comparator: Placebo NEXThaler<br>Placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 Area under the curve | FEV1= Forced expiratory volume in the first second of expiration | until 12 h post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 peak | Maximum FEV1 value | until 12 h post dose | 
| FVC area under the curve | FVC = Forced Vital Capacity | until 12 h post dose | 
| FVC peak | Maximum FVC | until 12 h post dose | 
| Adverse events | from the signature of the informed consent until the end of the study, the total duration depends on the duration of the run-in and wash-out periods. | over a period of 5 to 14 weeks |