Clinical trial NCT03836677: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-02-11
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Specific Image-based Airway Volume (siVaw)
timeFrame: Baseline, Day 29
measure: Specific Image-based Airway Resistance (siRaw)
timeFrame: Baseline, Day 29
Secondary outcomes:
measure: Image-based Airway Volume (iVaw)
timeFrame: Baseline, Day 29
measure: Image-based Airway Resistance (iRaw)
timeFrame: Baseline, 29 Days
measure: Forced Expiratory Volume in One Second (Post-dose FEV1).
timeFrame: Baseline 29 Days
measure: Functional Residual Capacity (FRC)
timeFrame: Baseline, Day 29
Other outcomes:
Locations:
city: Erpent
country: Belgium
facility: Research Site
city: Eindhoven
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Zutphen
country: Netherlands
facility: Research Site
Study officials:
References:
citation: van den Berge M, De Backer J, Van Holsbeke C, De Backer W, Trivedi R, Jenkins M, Dorinsky P, Aurivillius M. Functional respiratory imaging assessment of budesonide/glycopyrrolate/formoterol fumarate and glycopyrrolate/formoterol fumarate metered dose inhalers in patients with COPD: the value of inhaled corticosteroids. Respir Res. 2021 Jul 1;22(1):191. doi: 10.1186/s12931-021-01772-2.