Triple in Asthma Dose Finding

Study Overview
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Brief Summary
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The purpose of this study is to determine the optimal dose of CHF 5259 (glycopyrrolate bromide) on top of Foster which provides the optimal additive bronchodilator effect to asthmatic patients whose symptoms are uncontrolled with medium dose of inhaled corticosteroids plus long acting beta2 agonists.

Official Title
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A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 3-WAY CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A FREE COMBINATION OF 3 DOSES OF CHF 5259 (GLYCOPYRROLATE) PLUS FOSTER® 100/6 µg (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL) IN A METERED DOSE INHALER FOR THE TREATMENT OF PATIENTS WITH UNCONTROLLED ASTHMA UNDER MEDIUM DOSES OF INHALED CORTICOSTEROIDS PLUS LONG-ACTING β2-AGONISTS

Conditions
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Asthma

Intervention / Treatment
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* Drug: CHF 5259 plus Foster 100/6 µg
* Drug: Foster 100/6 µg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged >=18 years Uncontrolled asthma on medium doses of ICS+LABA with ACQ >=1.5 Pre-bronchodilator FEV1 ≥40% and <80% of their predicted normal value Exclusion Criteria: Pregnant or lactating women Diagnosis of COPD Patients treated for asthma exacerbations in the 4 weeks prior to study entry Patients who are in therapy for gastroesophageal reflux disease Patients who have a clinically significant cardiovascular condition

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: CHF 5259 25 µg plus Foster 100/6 µg<br> | Drug: CHF 5259 plus Foster 100/6 µg<br>* Comparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)<br>* Other names: glycopyrrolate + beclometasone/formoterol;|
| Experimental: CHF 5259 50 µg plus Foster 100/6 µg<br> | Drug: CHF 5259 plus Foster 100/6 µg<br>* Comparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)<br>* Other names: glycopyrrolate + beclometasone/formoterol;|
| Experimental: CHF 5259 100 µg plus Foster 100/6 µg<br> | Drug: CHF 5259 plus Foster 100/6 µg<br>* Comparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)<br>* Other names: glycopyrrolate + beclometasone/formoterol;|
| Active Comparator: Foster 100/6 µg<br> | Drug: Foster 100/6 µg<br>* Active comparator Comparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)<br>* Other names: beclometasone dipropionate/formoterol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 AUC0-12h normalised by time on Day 42 |  | Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak FEV1 on Day 42 |  | Day 42 | 
| Adverse Events and Adverse Drug Reactions |  | Up at Week 24 (study end) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, anticholinergics