A Phase 3 interventional study of Fluticasone 250mcg/Formoterol 12mcg/Glycopyrronium 25mcg and Comparator - Trimbow® in Chronic Obstructive Pulmonary Disease, sponsored by Eurofarma Laboratorios S.A.. Not yet recruiting at 1 site in Brazil. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Eurofarma Laboratorios S.A. · Phase 3, Interventional, and Treatment
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.
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).
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's planned enrollment of 1,252 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Eurofarma Laboratorios S.A. is the lead sponsor of 64 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants of both sexes who meet all of the following criteria will be included in the study:
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from the study:
Fluticasone Propionate 250 mcg/Formoterol Fumarate dihydrate 12 mcg/Glycopyrronium Bromide 25 mcg in the pharmaceutical form of hard capsule with powder for inhalation - 1 capsule per inhalation twice a day
Drug: Fluticasone 250mcg/Formoterol 12mcg/Glycopyrronium 25mcg
Beclomethasone Dipropionate 100 mcg/Formoterol Fumarate dihydrate 6 mcg/Glycopyrronium Bromide 12.5 mcg in pharmaceutical form aerosol solution in pressurized metered dose device (pMDI) for inhalation (Trimbow® - Chiesi Farmacêutica Ltda.) - 2 triggering twice a day
Drug: Comparator - Trimbow®
Participants randomized to this group will receive 1 capsule per inhalation twice a day
Also known as: Fluticasone Propionate 250 mcg/Formoterol Fumarate dihydrate 12 mcg/Glycopyrronium Bromide 25 mcg
Participants randomized to this group will receive 2 triggering twice a day
Also known as: Trimbow® - Beclomethasone Dipropionate 100 mcg/Formoterol Fumarate dihydrate 6 mcg/Glycopyrronium Bromide 12.5 mcg
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).
Time frame: week 12
Change to SGRQ (Saint George's Respiratory Questionnaire)
Change to SGRQ (Saint George's Respiratory Questionnaire) total score at week 12 compared to baseline
Time frame: week 12
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
Time frame: weeks 4 and 12
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
Eurofarma Laboratorios S.A.