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

NCT06234345 | Not Yet Recruiting Phase 3

• 1 other identifier: EF183
• Study Type: interventional
• Target: 1,252
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change to SGRQ (Saint George's Respiratory Questionnaire)

  week 12

• Change to the COPD (chronic obstructive pulmonary disease )

  weeks 4 and 12

Study Arms (2)

Fluticasone Propionate 250 mcg/Formoterol Fumarate dihydrate 12 mcg/Glycopyrronium Bromide 25 mcg

EXPERIMENTAL

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

Trimbow® (Beclomethasone 100 mcg/Formoterol 6 mcg/Glycopyrronium 12.5 mcg)

ACTIVE COMPARATOR

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®

Interventions

Fluticasone 250mcg/Formoterol 12mcg/Glycopyrronium 25mcg DRUG

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

Fluticasone Propionate 250 mcg/Formoterol Fumarate dihydrate 12 mcg/Glycopyrronium Bromide 25 mcg

Comparator - Trimbow® DRUG

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

Trimbow® (Beclomethasone 100 mcg/Formoterol 6 mcg/Glycopyrronium 12.5 mcg)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

Eurofarma Laboratorios S.A

São Paulo, Padrão, 06696-000, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone; Formoterol Fumarate; Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Quaternary Ammonium Compounds; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Edilene Macedo

CONTACT

+551150908600; edilene.macedo@eurofarma.com

Gleyce Pinto

CONTACT

+551150908600; gleyce.lima@eurofarma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Experimental Group: 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 Comparator Group: 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

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 31, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

BR (1)