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

NCT06234345
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Phase
Phase 3
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Recruitment status
Not yet recruiting
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Participants
1,252
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Lead sponsor
Eurofarma Laboratorios S.A.
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Start date
2026-09-01
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Number of sites
1
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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.
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Acronym
TRIPLAR
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Short title
Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-08-01
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First posted
2024-01-31
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Registry last updated
2025-02-14
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Primary completion date
2028-08-01
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Start date
2026-09-01
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Participants
1,252
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Participant count basis
Estimated
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Planned participants
1,252
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Protocol amendments
2
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eurofarma Laboratorios S.A.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06234345
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ClinicalTrials.gov ID
NCT06234345
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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).

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Healthy volunteers
No

  • 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).

  • 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
clinicaltrials.gov

  • Eurofarma Laboratorios S.ASão Paulo, Brazil
Sources for sites
clinicaltrials.gov

Related records

Drugs (4)

Lead sponsors (1)

Conditions (2)

Targets (3)