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

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

Sponsors

Lead sponsor: Chiesi Farmaceutici S.p.A.

Source 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.

Overall Status Completed
Start Date February 17, 2016
Completion Date May 17, 2018
Primary Completion Date May 17, 2018
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Pre-dose FEV1 (Forced Expiratory Volume in the first second) at Week 26
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
Reduction of moderate and severe asthma exacerbations rate Week 0 to Week 52
Secondary Outcome
Measure 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 Week 0 to Week 52
Enrollment 1153
Condition
Intervention

Intervention type: Drug

Intervention name: CHF 5993 100/6/12.5 µg

Arm group label: CHF 5993 100/6/12.5 µg

Intervention type: Drug

Intervention name: CHF 1535 100/6 µg

Arm group label: CHF 1535 100/6 µg

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Christian Virchow, MD Principal Investigator Facharzt für Innere Medizin Rostock, Germany
Location
facility
Chiesi Clinical Trial Site 276814
Location Countries

Germany

Verification Date

June 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: CHF 5993 100/6/12.5 µg

Arm group type: Experimental

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

Arm group label: CHF 1535 100/6 µg

Arm group type: Active Comparator

Description: Treatment B : CHF 1535 100/6 µg: 2 inhalations bid Total daily dose: 400/24 µg BDP/FF

Acronym TRIMARAN
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov