Back to results

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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

CHF 5993 100/6/12.5 µg

CHF 1535 100/6 µg

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, anticholinergics, triple combination

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chiesi Clinical Trial Site 276814

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CHF 5993 100/6/12.5 µg

CHF 1535 100/6 µg

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pre-dose FEV1 (Forced Expiratory Volume in the first second)

Reduction of moderate and severe asthma exacerbations rate

Secondary Outcome Measures

Peak FEV1 (Peak of Forced Expiratory Volume in the first second) within 3 hours post-dose

Change from baseline in morning PEF (Peak Expiratory Flow)

Reduction of severe asthma exacerbations rate

Pooled analysis of CCD-05993AB1-03 and CCD-05993AB2-02 trials

Full Information

NCT ID

NCT02676076

First Posted

February 3, 2016

Last Updated

April 6, 2021

Sponsor

Chiesi Farmaceutici S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT02676076

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

February 17, 2016 (Actual)

Primary Completion Date

May 17, 2018 (Actual)

Study Completion Date

May 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

asthma, anticholinergics, triple combination

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1153 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CHF 5993 100/6/12.5 µg

Arm Type

Experimental

Arm Description

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

Arm Title

CHF 1535 100/6 µg

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CHF 5993 100/6/12.5 µg

Intervention Type

Drug

Intervention Name(s)

CHF 1535 100/6 µg

Primary Outcome Measure Information:

Title

Pre-dose FEV1 (Forced Expiratory Volume in the first second)

Time Frame

at Week 26

Title

Reduction of moderate and severe asthma exacerbations rate

Time Frame

Week 0 to Week 52

Secondary Outcome Measure Information:

Title

Peak FEV1 (Peak of Forced Expiratory Volume in the first second) within 3 hours post-dose

Time Frame

at Week 26

Title

Change from baseline in morning PEF (Peak Expiratory Flow)

Time Frame

Week 0 to Week 26

Title

Reduction of severe asthma exacerbations rate

Description

Pooled analysis of CCD-05993AB1-03 and CCD-05993AB2-02 trials

Time Frame

Week 0 to Week 52

Other Pre-specified Outcome Measures:

Title

Adverse Events and Adverse Drug reactions

Time Frame

Up to Week 52

Title

Collection of Health Economics outcomes

Description

Total use of healthcare resources and absence from work

Time Frame

Week 0 to Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Virchow, MD

Organizational Affiliation

Facharzt für Innere Medizin Rostock, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chiesi Clinical Trial Site 276814

City

Rostock

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information. Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

IPD Sharing Access Criteria

Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

IPD Sharing URL

https://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/

Citations:

PubMed Identifier

31582314

Citation

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, controlled phase 3 trials. Lancet. 2019 Nov 9;394(10210):1737-1749. doi: 10.1016/S0140-6736(19)32215-9. Epub 2019 Sep 30.

Results Reference

result

PubMed Identifier

35872377

Citation

Orlovic M, Magni T, Lukyanov V, Guerra I, Madoni A. Cost-effectiveness of single-inhaler extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium in patients with uncontrolled asthma in England. Respir Med. 2022 Sep;201:106934. doi: 10.1016/j.rmed.2022.106934. Epub 2022 Jul 19.

Results Reference

derived

PubMed Identifier

35450196

Citation

Papi A, Singh D, Virchow JC, Canonica GW, Vele A, Georges G. Normalisation of airflow limitation in asthma: Post-hoc analyses of TRIMARAN and TRIGGER. Clin Transl Allergy. 2022 Apr 17;12(4):e12145. doi: 10.1002/clt2.12145. eCollection 2022 Apr.

Results Reference

derived

PubMed Identifier

33121501

Citation

Singh D, Virchow JC, Canonica GW, Vele A, Kots M, Georges G, Papi A. Determinants of response to inhaled extrafine triple therapy in asthma: analyses of TRIMARAN and TRIGGER. Respir Res. 2020 Oct 29;21(1):285. doi: 10.1186/s12931-020-01558-y.

Results Reference

derived

PubMed Identifier

32430414

Citation

Singh D, Virchow JC, Canonica GW, Vele A, Kots M, Georges G, Papi A. Extrafine triple therapy in patients with asthma and persistent airflow limitation. Eur Respir J. 2020 Sep 24;56(3):2000476. doi: 10.1183/13993003.00476-2020. Print 2020 Sep. No abstract available.

Results Reference

derived

Links:

URL

https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-000716-18/results

Description

Study Record on EU Clinical Trials Register including results.

Learn more about this trial

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

We'll reach out to this number within 24 hrs