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

Asthma Clinical Trial

— TRIMARAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676076
• Other study ID #: CCD-05993AB1-03
• Secondary ID: 2015-000716-18
• Status: Completed
• Phase: Phase 3
• Start date: February 17, 2016
• Est. completion date: May 17, 2018

Study information

• Verified date: April 2021
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1153
• Est. completion date: May 17, 2018
• Est. primary completion date: May 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CHF 5993 100/6/12.5 µg

• CHF 1535 100/6 µg

Locations

Country	Name	City	State
Germany	Chiesi Clinical Trial Site 276814	Rostock

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Virchow JC, Kuna P, Paggiaro P, Papi A, Singh D, Corre S, Zuccaro F, Vele A, Kots M, Georges G, Petruzzelli S, Canonica GW. Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER): two double-blind, parallel-group, randomised — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events and Adverse Drug reactions		Up to Week 52
Other	Collection of Health Economics outcomes	Total use of healthcare resources and absence from work	Week 0 to Week 52
Primary	Pre-dose FEV1 (Forced Expiratory Volume in the first second)		at Week 26
Primary	Reduction of moderate and severe asthma exacerbations rate		Week 0 to Week 52
Secondary	Peak FEV1 (Peak of Forced Expiratory Volume in the first second) within 3 hours post-dose		at Week 26
Secondary	Change from baseline in morning PEF (Peak Expiratory Flow)		Week 0 to Week 26
Secondary	Reduction of severe asthma exacerbations rate	Pooled analysis of CCD-05993AB1-03 and CCD-05993AB2-02 trials	Week 0 to Week 52

External Links

•   Study Record on EU Clinical Trials Register including results.