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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: CHF 5993 100/6/12.5 µg; Drug: CHF 1535 100/6 µg

• Registration Number: NCT02676076
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-08
• Study Start: 2016-02-17
• Primary Completion: 2018-05-17
• Study Completion: 2018-05-17
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHF 5993 100/6/12.5 µg	CHF 5993 100/6/12.5 µg	Treatment A: CHF 5993 100/6/12.5 µg: 2 inhalations bid Total daily dose: 400/24/50 µg BDP/FF/GB
CHF 1535 100/6 µg	CHF 1535 100/6 µg	Treatment B : CHF 1535 100/6 µg: 2 inhalations bid Total daily dose: 400/24 µg BDP/FF

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	Week 0 to Week 52	Pooled analysis of CCD-05993AB1-03 and CCD-05993AB2-02 trials

Trial Locations

Locations (1)

Chiesi Clinical Trial Site 276814; 🇩🇪 Rostock, Germany