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

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Combination Product: BGF; Combination Product: GFF

• Registration Number: NCT03836677
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

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 specific image based airway volumes and resistance in subjects with moderate to severe Chronic Obstructive Pulmonary Disease. In this study, airway dimension parameters will be calculated for each of the active compounds.

This imaging methodology will allow an assessment of the extent of airway changes using a triple combination of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and the dual combination Glycopyrronium/Formoterol Fumarate (GFF).

Study Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-11
• Study Start: 2019-02-26
• Primary Completion: 2019-11-11
• Study Completion: 2019-11-11
• Results First Submitted: 2020-11-10
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-25
• Last Update Submitted: 2021-01-25
• Results First Posted: 2021-02-11
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Subject must be 40 years to ≤80 years of age inclusive, at the time of signing the informed consent form at Visit 1.

• COPD Diagnosis: Subjects with an established clinical history of COPD
• Screening clinical laboratory tests must be acceptable to the Investigator.
• Screening ECG must be acceptable to the Investigator
• Individual Compliance: Subjects must be willing to remain at the study center as required per protocol to complete all visit assessments
• Patients should be on scheduled maintenance treatment with one or more inhaled bronchodilator therapies.

Exclusion Criteria

• As judged by the investigator, any evidence of significant diseases other than COPD, i.e., disease or condition which, in the investigator's opinion makes it undesirable for the subject to participate in the trial.

• Spirometry Performance:

  1. Subjects who cannot perform acceptable spirometry, i.e., meet ATS/ERS acceptability criteria.
  2. Repeatability: Subjects who cannot perform technically acceptable spirometry in accordance with ATS repeatability criteria

• Cancer: Subjects who have cancer that has not been in complete remission for at least five years.

• Substance Abuse: Subjects, who in the opinion of the Investigator, significantly abuse alcohol or drugs

• Subjects who in the opinion of the investigator are unable to abstain from prohibited medications including LABA/LAMAs/ICS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BGF-GFF	GFF	Subject first treated with Budesonide/Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Glycopyrronium/Formoterol Fumarate
GFF-BGF	BGF	Subject first treated with Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Budesonide/Glycopyrronium/Formoterol Fumarate
BGF-GFF	BGF	Subject first treated with Budesonide/Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Glycopyrronium/Formoterol Fumarate
GFF-BGF	GFF	Subject first treated with Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Budesonide/Glycopyrronium/Formoterol Fumarate

Primary Outcome Measures

Name	Time	Method
Specific Image-based Airway Volume (siVaw)	Baseline, Day 29	Specific image-based airway volume (SiVaw) measured in mL/L. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline.
Specific Image-based Airway Resistance (siRaw)	Baseline, Day 29	Specific image-based airway resistance (siRaw) measured in kPa∙s. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline.

Secondary Outcome Measures

Name	Time	Method
Image-based Airway Volume (iVaw)	Baseline, Day 29	Image-based Airway Volume (iVaw) measured in mL. Average across lobes, without adjustment for lobe volume. Reported as ratio to baseline.
Image-based Airway Resistance (iRaw)	Baseline, 29 Days	Image-based airway resistance (iRaw) measured in kPa∙s/L. Average across lobes, without adjustment for lobe volume. Reported as ratio to baseline.
Forced Expiratory Volume in One Second (Post-dose FEV1).	Baseline 29 Days	Change from baseline in Forced Expiratory Volume in One Second (Post-dose FEV1).
Functional Residual Capacity (FRC)	Baseline, Day 29	Change from baseline in Functional residual capacity (FRC).

Trial Locations

Locations (1)

Research Site; 🇳🇱 Zutphen, Netherlands