Efficacy and Safety of ICS/LABA vs. LAMA/LABA in Patients With Different COPD Phenotypes.

NCT05342558 | Completed Phase 4 DMC

• 1 other identifier: C49-17
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, blinded, controlled clinical trial for mexican COPD patients. Biomass smoke associated COPD (BS-COPD) clinical spectrum is different to the one seen in tobacco smoke associated COPD (TS-COPD). BS-COPD patients present COPD-asthma phenotype or asthma-COPD overlap syndrome (ACOS), TS-COPD patients present mostly the emphysema phenotype. BS-COPD patients have a greater risk of exacerbations in comparison to the emphysema phenotype. Therefore, individualizing treatment in both phenotypes may be very useful among the clinical practitioners. The investigators expect treatment with FF/V to be superior in preventing COPD exacerbations than the U/V combination in patients with COPD-asthma phenotype; andU/V to be superior than FF/V in patients with the emphysema phenotype. The general objective of the study is to determine the exacerbations outcome in patients with COPD-asthma vs emphysema phenotype patients, treated with both drugs. Secondary objectives include assessment of pulmonary function tests, quality of life, dyspnea and functional capacity change after a 24 weeks treatment.

Conditions

COPD

Keywords

Chronic obstructive pulmonary disease; Biomass; Tobacco; COPD treatment; COPD phenotypes

Outcome Measures

Primary Outcomes (2)

• Exacerbations rate

  moderate and severe exacerbations rate

  baseline to 24 weeks

• Exacerbations free interval

  Exacerbations free interval

  Baseline to first exacerbation

Secondary Outcomes (7)

• Pulmonary function change

  Change from Baseline at 4, 12 and 24 weeks

• Impulse oscillometry resistance change

  Change from baseline at 24 weeks

• FeNO change

  change from Baseline at 24 weeks

• Quality of life change

  change from Baseline at 4, 12 and 24 weeks

• Dyspnea change

  Change from Baseline at 4, 12 and 24 weeks

Study Arms (2)

Biomass Smoke COPD

ACTIVE COMPARATOR

Fluticasone Furoate/Vilanterol 100/25 mcgs. Dry powder inhaler with 30 blisters. 1 inhalation a day for 24 weeks. Umeclidinium/Vilanterol 62.5/25 mcgs. Dry powder inhaler with 30 blisters. 1 inhalation a day for 24 weeks.

Drug: Fluticasone Furoate/Vilanterol 100/25 mcgs; Drug: Umeclidinium/Vilanterol 62.5/25 mcgs

Tobacco Smoke COPD

ACTIVE COMPARATOR

Fluticasone Furoate/Vilanterol 100/25 mcgs. Dry powder inhaler with 30 blisters. 1 inhalation a day for 24 weeks. Umeclidinium/Vilanterol 62.5/25 mcgs. Dry powder inhaler with 30 blisters. 1 inhalation a day for 24 weeks.

Drug: Fluticasone Furoate/Vilanterol 100/25 mcgs; Drug: Umeclidinium/Vilanterol 62.5/25 mcgs

Interventions

Fluticasone Furoate/Vilanterol 100/25 mcgs DRUG

Dry powder inhaler with 30 blisters. 100/25mcgs a day for 24 weeks.

Also known as: Relvare

Biomass Smoke COPD; Tobacco Smoke COPD

Umeclidinium/Vilanterol 62.5/25 mcgs DRUG

Dry powder inhaler with 30 blisters. 62.5/25mcgs a day for 24 weeks

Also known as: Anoro

Biomass Smoke COPD; Tobacco Smoke COPD

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 40 to 80 years
• Men and women (not fertile, not pregnant, or those with a effective birth control method)
• COPD diagnosis according to GOLD 2017 criteria with a FEV1 ≥ 30%
• Biomass smoke exposition index ≥ 100 hours/year or smoking index ≥ 10 packs/year,
• Patients with at least two exacerbations in the last 12 months (confirmed by the prescription of antibiotic and/or oral steroid)

You may not qualify if:

• Patients with allergies or intolerance to study medications
• Female patients on pregnancy, lactancy
• Patients with cancer diagnosis
• Patients with bronchiectasis, tuberculosis, recent COPD exacerbation, or any respiratory infection or cardiovascular anomaly that withholds the respiratory function test

Sponsors & Collaborators

• National Institute of Respiratory Diseases, Mexico: lead

Study Sites (1)

National Institute of Respiratory Diseases 'Ismael Cosío Villegas'

Mexico City, Tlalpan, 14080, Mexico

Location

Related Publications (20)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

fluticasone furoate; GSK573719

Condition Hierarchy (Ancestors)

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

Study Officials

• Alejandra Ramírez-Venegas, M.S.

  Instituto Nacional de Enfermedades Respiratorias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 22, 2022
• Study Start: September 19, 2017
• Primary Completion: November 19, 2020
• Study Completion: February 1, 2021
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

ME (1)