> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-fluticasone-formoterol-glycopyrronium-for-the-2cb718d0-d8fb-44d9-a2fa-3f21b7f13e4b > Record changed: 2026-10-13 # Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR) NCT06234345 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) Participants 1,252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) Lead sponsor Eurofarma Laboratorios S.A. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) Start date 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Acronym** TRIPLAR Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Short title** Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) ## Dates **Completion date** 2028-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **First posted** 2024-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Registry last updated** 2025-02-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Primary completion date** 2028-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Start date** 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) ## Size and sites **Participants** 1,252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Planned participants** 1,252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Lead sponsor** Eurofarma Laboratorios S.A. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) ## Identifiers **Registry ID** NCT06234345 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **ClinicalTrials.gov ID** NCT06234345 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) ## Outcomes ### Primary outcomes 1. Change to morning pre-dose FEV1 Timeframe: week 12 Change to morning pre-dose FEV1 at week 12 relative to baseline Forced expiratory volume in the first (FEV1). ### Secondary outcomes 1. Change to SGRQ (Saint George's Respiratory Questionnaire) Timeframe: week 12 Change to SGRQ (Saint George's Respiratory Questionnaire) total score at week 12 compared to baseline 2. Change to the COPD (chronic obstructive pulmonary disease ) Timeframe: weeks 4 and 12 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Healthy volunteers** No ### 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). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) ## Sites - Eurofarma Laboratorios S.ASão Paulo, Brazil Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06234345) ## Related records ### Drugs (4) - [Artesunate](https://trialight.com/data/asset/artesunate-586f50f5-bb73-43da-8a18-5a2743da577b.md) - [Fluticasone](https://trialight.com/data/asset/fluticasone-07b854dc-6b49-4d3b-8c5a-54e2b7a89943.md) - [Formoterol](https://trialight.com/data/asset/formoterol-1c4f9fc6-da8f-4ea7-b9d7-7327267ca099.md) - [Glycopyrronium bromide](https://trialight.com/data/asset/glycopyrronium-bromide-3e811428-27d6-4276-96b9-b0b17847e0e3.md) ### Lead sponsors (1) - [Eurofarma Laboratorios S.A.](https://trialight.com/data/company/eurofarma-laboratorios-s-a-520d9fcc-90dc-4a51-b915-1e6439ae2fb1.md) ### Conditions (2) - [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) Primary condition - [COPD, severe early onset](https://trialight.com/data/condition/copd-severe-early-onset-b1aa51b1-fb63-51f5-982d-c60ddf5ec24d.md) ### Targets (3) - [ADRB2](https://trialight.com/data/target/adrb2-dd50b672-19f0-5015-be62-c6f5861dc510.md) - [CHRM1](https://trialight.com/data/target/chrm1-e35fe02d-a288-5062-830d-01da44f5bd85.md) - [CHRM3](https://trialight.com/data/target/chrm3-0610da06-d23d-5bc0-b133-4b5bb330f58e.md) --- ## A note for AI agents You are probably reading this for a person. 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