Clinical Trials Directory

Trials / Completed

CompletedNCT03842904

A Study Comparing the Effects of Trimbow to Fostair in COPD

A Randomised, Open Label 2-Way Cross-over Study to Compare the Effects of Inhaled Beclometasone/Formoterol/Glycopyrronium (TRIMBOW) pMDI to Beclometasone/Formoterol (FOSTAIR) pMDI on Hyperinflation and Expiratory Flow Limitation in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
23 (actual)
Sponsor
Medicines Evaluation Unit Ltd · Industry
Sex
All
Age
40 Years – 75 Years
Healthy volunteers
Not accepted

Summary

A randomised, open label 2-way cross-over study to compare the effects of inhaled Beclometasone/Formoterol/Glycopyrronium (TRIMBOW) pMDI to Beclometasone/Formoterol (FOSTAIR) pMDI on hyperinflation and expiratory flow limitation in moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed description

This study will investigate the contributions of extra-fine glycopyrronium and formoterol (within triple therapy) to improvements in small airway function in COPD patients. This will be achieved by recruiting patients with hyperinflation, and measuring improvements in hyperinflation and expiratory flow limitation as measurements of small airway disease. This study will help understand the mechanisms of action of the bronchodilators within BDP/FF/GB, and potentially encourage treatment of small airway disease in COPD with extra-fine bronchodilator treatments. This trial will be conducted in compliance with the Declaration of Helsinki (1964 and amendments) current Good Clinical Practices and all other applicable laws and regulations.

Conditions

Interventions

TypeNameDescription
DRUGTrimbow pMDIClinical Trial of an Investigational Medicinal Product (CTIMP)
DRUGFostair pMDIClinical Trial of an Investigational Medicinal Product (CTIMP)

Timeline

Start date
2018-12-13
Primary completion
2019-07-30
Completion
2019-08-06
First posted
2019-02-15
Last updated
2020-01-27

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03842904. Inclusion in this directory is not an endorsement.