NCT06234345Not yet recruitingPhase 3
Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)
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 · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1252 (estimated)
- First submitted
- 3 Jan 2024
- Start date
- 30 Jan 2027
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Diseases
- COPD
- NCT number
- NCT06234345
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1252
- From 30 Jan 2027 to the primary completion date, 31 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who meet any of the following criteria will be excluded from the study:
- Pregnant or lactating women.
- 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).
- Other respiratory disorders other than chronic obstructive pulmonary disease (COPD) (for example, but not restricted to: active tuberculosis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension).
Who the study is looking for
- Participants of both sexes who meet all of the following criteria will be included in the study:
- Signed Informed Consent Form (ICF).
- Male or female aged 40 or over.
- 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).
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eurofarma Laboratorios S.A Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.