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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

A Randomized, Double-blind, Two Treatment, Two Period, Chronic Dosing (4 Weeks), Crossover, Multi-center Pilot Study to Evaluate the Effects of Budesonide/Glycopyrronium/Formoterol Fumarate and Glycopyrronium/Formoterol Fumarate on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03836677
• Other study ID #: D5980C00019
• Status: Completed
• Phase: Phase 3
• Start date: February 26, 2019
• Est. completion date: November 11, 2019

Study information

• Verified date: January 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 11, 2019
• Est. primary completion date: November 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Combination Product:
• BGF
Treatment with Budesonide/Glycopyrronium/FormoterolFumarate
• GFF
Treatment with Glycopyrronium/Formoterol Fumarate

Locations

Country	Name	City	State
Belgium	Research Site	Erpent
Netherlands	Research Site	Eindhoven
Netherlands	Research Site	Groningen
Netherlands	Research Site	Zutphen

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific Image-based Airway Volume (siVaw)	Specific image-based airway volume (SiVaw) measured in mL/L. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline.	Baseline, Day 29
Primary	Specific Image-based Airway Resistance (siRaw)	Specific image-based airway resistance (siRaw) measured in kPa·s. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline.	Baseline, Day 29
Secondary	Image-based Airway Volume (iVaw)	Image-based Airway Volume (iVaw) measured in mL. Average across lobes, without adjustment for lobe volume. Reported as ratio to baseline.	Baseline, Day 29
Secondary	Image-based Airway Resistance (iRaw)	Image-based airway resistance (iRaw) measured in kPa·s/L. Average across lobes, without adjustment for lobe volume. Reported as ratio to baseline.	Baseline, 29 Days
Secondary	Forced Expiratory Volume in One Second (Post-dose FEV1).	Change from baseline in Forced Expiratory Volume in One Second (Post-dose FEV1).	Baseline 29 Days
Secondary	Functional Residual Capacity (FRC)	Change from baseline in Functional residual capacity (FRC).	Baseline, Day 29

External Links

•   CSP
•   Statistical Analysis Plan (SAP)