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A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

NCT03836677 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-02-11

Study results available
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Summary

This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and Glycopyrronium/Formoterol Fumarate (GFF) on airway dimensions.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

COMBINATION_PRODUCT

BGF

Treatment with Budesonide/Glycopyrronium/FormoterolFumarate

COMBINATION_PRODUCT

GFF

Treatment with Glycopyrronium/Formoterol Fumarate

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-26
Primary Completion
2019-11-11
Completion
2019-11-11
FDA Drug
Yes

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03836677 on ClinicalTrials.gov