Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)

Chronic Obstructive Pulmonary Disease Clinical Trial

— TRIPLAR  

Official title:

Randomized, Open-label, Parallel, Active-controlled, Multicenter Study of Efficacy and Safety of Fixed-dose Combination of Fluticasone /Formoterol /Glycopyrronium for the Treatment of Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06234345
• Other study ID #: EF183
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 28, 2026
• Est. completion date: July 30, 2028

Study information

• Verified date: January 2024
• Source: Eurofarma Laboratorios S.A.
• Contact: Edilene Macedo
• Phone: +551150908600
• Email: edilene.macedo[@]eurofarma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Several studies have demonstrated the benefits of the LAMA (Long-Acting Muscarinic Antagonists) + LABA (Long-Acting Beta-Agonists) + IC (inhaled corticosteroids) combination in the treatment of chronic obstructive pulmonary disease (COPD). The use of the triple combination in patients with severe airflow obstruction and a history of flares has been associated with improved lung function, improved patient-reported endpoints and prevention of flares, when compared to LABA, LABA + LAMA and LABA + IC. Furthermore, when compared to dual therapies LABA + IC and LABA + LAMA, triple therapy has been able to reduce all-cause deaths among chronic obstructive pulmonary disease (COPD) patients.

Previously published studies have demonstrated that the triple combination of Fluticasone 250 mcg/Formoterol 12 mcg/Glycopyrronium 12.5 mcg was able to improve lung function in chronic obstructive pulmonary disease (COPD) patients with a history of flares. There was also a significant improvement in the mMRC (modified-Medical Research Council) which began in the 2nd week of treatment and continued up to week 12. The association was considered safe and well tolerated, with only mild to moderate adverse events recorded in approximately 25% of the subjects treated in the study.

Furthermore, bioavailability studies performed with the components of the combination proposed as experimental drug - Fluticasone/Formoterol/Glycopyrronium - indicated that there is no pharmacokinetic interaction between the 3 active ingredients when they were administered concomitantly to healthy individuals under fasting conditions.

Description:

This is a phase 3 non-inferiority, randomized, open-label study with active control to compare the efficacy and safety of a fixed-dose triple combination to another triple combination with already established efficacy in subjects with symptomatic chronic obstructive pulmonary disease (COPD).

This study will be conducted in two stages. Study Step 1 The primary assessment of non-inferiority will be performed after 12 weeks of treatment by assessing FEV1 (Forced expiratory volume in the first second) in relation to baseline.

Study Step 2 In a second step, it will be assessed whether the benefits of the new triple combination on respiratory symptoms and health-related quality of life are sustained in the long term and to determine the annual rate of flares in 52 weeks of treatment.

The study will comprise a screening phase, consisting of a screening and run-in visit lasting up to 14 days, and a treatment phase in which, after collecting baseline data (which includes assessment of FEV1 (Forced expiratory volume in the first second) and quality of life through a questionnaire), participants will be randomized and begin their respective treatments.

Visits during Step 1 of treatment will be performed at weeks 4 and 12. The week 12 visit will be the primary endpoint visit.

After 12 weeks, Step 2 of the study will begin with all participants who completed Step 1 and who agreed to remain in the study to receive Eurofarma's experimental drug for up to 52 weeks. Visits during this step will be performed at weeks 24, 36 and 52 to assess safety, quality of life, lung function and flare rate (exploratory endpoints).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 986
• Est. completion date: July 30, 2028
• Est. primary completion date: November 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Participants of both sexes who meet all of the following criteria will be included in the study:

1. Signed Informed Consent Form (ICF).

2. Male or female aged 40 or over.

3. Medical diagnosis of chronic obstructive pulmonary disease (COPD) documented by post-bronchodilator FEV1/FVC (Forced Expiratory Volume in the 1st second/ Forced Vital Capacity) ratio < 0.7 (Previous examination report or examination performed at the screening visit).

Exclusion Criteria:

• Participants who meet any of the following criteria will be excluded from the study:

1. Pregnant or lactating women.

2. Current diagnosis of asthma without current diagnosis of chronic obstructive pulmonary disease (COPD). Observation: Subjects with a prior history of asthma are eligible if they have a current diagnosis of chronic obstructive pulmonary disease (COPD).

3. Other respiratory disorders other than chronic obstructive pulmonary disease (COPD) (for example, but not restricted to: active tuberculosis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Fluticasone 250mcg/Formoterol 12mcg/Glycopyrronium 25mcg
Participants randomized to this group will receive 1 capsule per inhalation twice a day
• Comparator - Trimbow®
Participants randomized to this group will receive 2 triggering twice a day

Locations

Country	Name	City	State
Brazil	Eurofarma Laboratorios S.A	São Paulo	Padrão

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change to morning pre-dose FEV1	Change to morning pre-dose FEV1 at week 12 relative to baseline Forced expiratory volume in the first (FEV1).	week 12
Secondary	Change to SGRQ (Saint George's Respiratory Questionnaire)	Change to SGRQ (Saint George's Respiratory Questionnaire) total score at week 12 compared to baseline	week 12
Secondary	Change to the COPD (chronic obstructive pulmonary disease )	Change to the COPD (chronic obstructive pulmonary disease ) Assessment Test (CAT - questionnaire to measure the impact of COPD on a person's life) in weeks 4 and 12 in relation to baseline	weeks 4 and 12