TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the superiority of CHF 5993 100/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronum bromide) versus CHF 1535 100/6 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate), in terms of lung functions parameters and rate of exacerbations, as well as to assess its safety and some health economics outcomes.

Official Title
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A 52 WEEK, RANDOMIZED, DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, ACTIVE CONTROLLED, 2-ARM PARALLEL GROUP TRIAL COMPARING CHF 5993 100/6/12.5 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) TO CHF 1535 100/6 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE) IN PATIENTS WITH ASTHMA UNCONTROLLED ON MEDIUM DOSES OF INHALED CORTICOSTEROIDS IN COMBINATION WITH LONG ACTING ß2 AGONISTS

Conditions
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Asthma

Intervention / Treatment
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* Drug: CHF 5993 100/6/12.5 µg
* Drug: CHF 1535 100/6 µg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of asthma ≥ 1 year and diagnosed before 40 years old Uncontrolled asthma with double therapy only on medium doses of Inhaled CorticoSteroid (ICS) in combination with Long-acting beta2 Agonist (LABA) with ACQ-7 (Asthma Control Questionnaire) ≥1.5 Pre-bronchodilator FEV1 <80% of the predicted normal value Positive reversibility test At least 1 documented asthma exacerbation in the previous year Exclusion Criteria: Pregnant or lactating women Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Patients with any asthma exacerbation or respiratory tract infection in the 4 weeks prior screening Current or ex-smokers (>= 10 packs year) Any change in dose, schedule or formulation of ICS + LABA combination in the 4 weeks prior screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHF 5993 100/6/12.5 µg<br>Treatment A: CHF 5993 100/6/12.5 µg: 2 inhalations bid Total daily dose: 400/24/50 µg BDP/FF/GB | Drug: CHF 5993 100/6/12.5 µg<br> <br> |
| Active Comparator: CHF 1535 100/6 µg<br>Treatment B : CHF 1535 100/6 µg: 2 inhalations bid Total daily dose: 400/24 µg BDP/FF | Drug: CHF 1535 100/6 µg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-dose FEV1 (Forced Expiratory Volume in the first second) |  | at Week 26 | 
| Reduction of moderate and severe asthma exacerbations rate |  | Week 0 to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak FEV1 (Peak of Forced Expiratory Volume in the first second) within 3 hours post-dose |  | at Week 26 | 
| Change from baseline in morning PEF (Peak Expiratory Flow) |  | Week 0 to Week 26 | 
| Reduction of severe asthma exacerbations rate | Pooled analysis of CCD-05993AB1-03 and CCD-05993AB2-02 trials | Week 0 to Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, anticholinergics, triple combination