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CompletedNCT03836677Updated Feb 11, 2021Results posted

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

A Phase 3 interventional study of BGF and GFF in Chronic Obstructive Pulmonary Disease (COPD), sponsored by AstraZeneca. Completed at 4 sites in 2 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-11.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)

Keywords

  • COPD
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 23 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    BGF-GFF

    Subject first treated with Budesonide/Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Glycopyrronium/Formoterol Fumarate

    Combination Product: BGF · Combination Product: GFF

  • Experimental
    GFF-BGF

    Subject first treated with Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Budesonide/Glycopyrronium/Formoterol Fumarate

    Combination Product: BGF · Combination Product: GFF

Interventions

  • Combination productBGF

    Treatment with Budesonide/Glycopyrronium/FormoterolFumarate

  • Combination productGFF

    Treatment with Glycopyrronium/Formoterol Fumarate

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Day 29

  2. 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.

    Time frame: Baseline, Day 29

Secondary outcomes

  1. 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.

    Time frame: Baseline, Day 29

  2. 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.

    Time frame: Baseline, 29 Days

  3. Forced Expiratory Volume in One Second (Post-dose FEV1).

    Change from baseline in Forced Expiratory Volume in One Second (Post-dose FEV1).

    Time frame: Baseline 29 Days

  4. Functional Residual Capacity (FRC)

    Change from baseline in Functional residual capacity (FRC).

    Time frame: Baseline, Day 29

07

Results

Posted Feb 11, 2021

Participant flow

This study randomized 23 subjects at 4 study centers (1 center in Belgium and 3 centers in the Netherlands) from Feb 2019 to Nov 2019.

Period 1
Participant flow — Period 1
MilestoneBGF MDI/GFF MDIGFF MDI/BGF MDI
Started1310
Completed139
Not completed01
Withdrew: Adverse event01
Washout
Participant flow — Washout
MilestoneBGF MDI/GFF MDIGFF MDI/BGF MDI
Started139
Completed139
Not completed00
Period 2
Participant flow — Period 2
MilestoneBGF MDI/GFF MDIGFF MDI/BGF MDI
Started139
Completed129
Not completed10
Withdrew: Severe non-compliance to protocol10

Outcome measures

PrimarySpecific 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.

Time frame:
Baseline, Day 29
Reported as:
Geometric mean · Ratio to baseline
Specific Image-based Airway Volume (siVaw)
Ratio to baselineBGF MDIGFF MDI
Specific Image-based Airway Volume (siVaw)1.72 (1.38 to 2.13)1.53 (1.28 to 1.83)
Statistical analysis
  • BGF MDI · t-test, 2 sided · p = <0.0001 (Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.) · Geometric mean ratio to baseline: 1.72 · 95% CI 1.38 to 2.13Within-group comparison to baseline using paired test
  • GFF MDI · t-test, 2 sided · p = <0.0001 (Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.) · Geometric mean ratio to baseline: 1.53 · 95% CI 1.28 to 1.83Within-group comparison to baseline using paired test.
PrimarySpecific 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.

Time frame:
Baseline, Day 29
Reported as:
Geometric mean · Ratio to baseline
Specific Image-based Airway Resistance (siRaw)
Ratio to baselineBGF MDIGFF MDI
Specific Image-based Airway Resistance (siRaw)0.50 (0.39 to 0.63)0.52 (0.40 to 0.67)
Statistical analysis
  • BGF MDI · t-test, 2 sided · p = <0.0001 (Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.) · Geometric mean ratio to baseline: 0.50 · 95% CI 0.39 to 0.63Within-group comparison to baseline using paired test
  • GFF MDI · t-test, 2 sided · p = <0.0001 (Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.) · Geometric mean ratio to baseline: 0.52 · 95% CI 0.40 to 0.67Within-group comparison to baseline using paired test
SecondaryImage-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.

Time frame:
Baseline, Day 29
Reported as:
Geometric mean · Ratio to baseline
Image-based Airway Volume (iVaw)
Ratio to baselineBGF MDIGFF MDI
Image-based Airway Volume (iVaw)1.70 (1.37 to 2.11)1.51 (1.26 to 1.80)
Statistical analysis
  • BGF MDI · t-test, 2 sided · p = <0.0001 · Geometric mean ratio to baseline: 1.70 · 95% CI 1.37 to 2.11Within-group comparison to baseline using paired test
  • GFF MDI · t-test, 2 sided · p = 0.0001 · Geometric mean ratio to baseline: 1.51 · 95% CI 1.26 to 1.80Within-group comparison to baseline using paired test
SecondaryImage-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.

Time frame:
Baseline, 29 Days
Reported as:
Geometric mean · Ratio to baseline
Image-based Airway Resistance (iRaw)
Ratio to baselineBGF MDIGFF MDI
Image-based Airway Resistance (iRaw)0.50 (0.40 to 0.63)0.52 (0.40 to 0.68)
Statistical analysis
  • BGF MDI · t-test, 2 sided · p = <0.0001 · Geometric mean ratio to baseline: 0.50 · 95% CI 0.40 to 0.63Within-group comparison to baseline using paired test
  • GFF MDI · t-test, 2 sided · p = <0.0001 · Geometric mean ratio to baseline: 0.52 · 95% CI 0.40 to 0.68Within-group comparison to baseline using paired test
SecondaryForced Expiratory Volume in One Second (Post-dose FEV1).

Change from baseline in Forced Expiratory Volume in One Second (Post-dose FEV1).

Time frame:
Baseline 29 Days
Reported as:
Mean · L
Forced Expiratory Volume in One Second (Post-dose FEV1).
LBGF MDIGFF MDI
Forced Expiratory Volume in One Second (Post-dose FEV1).0.346 (0.182 to 0.509)0.273 (0.140 to 0.405)
Statistical analysis
  • BGF MDI · t-test, 2 sided · p = 0.0003 · Mean change from baseline: 0.346 · 95% CI 0.182 to 0.509Within-group comparison to baseline using paired test.
  • GFF MDI · t-test, 2 sided · p = 0.0004 · Mean change from baseline: 0.273 · 95% CI 0.140 to 0.405Within-group comparison to baseline using paired test.
SecondaryFunctional Residual Capacity (FRC)

Change from baseline in Functional residual capacity (FRC).

Time frame:
Baseline, Day 29
Reported as:
Mean · L
Functional Residual Capacity (FRC)
LBGF MDIGFF MDI
Functional Residual Capacity (FRC)-0.28 (-0.77 to 0.21)-0.50 (-0.81 to -0.18)
Statistical analysis
  • BGF MDI · t-test, 2 sided · p = 0.2515 · Mean ratio to baseline: -0.28 · 95% CI -0.77 to 0.21Within-group comparison to baseline using paired test.
  • GFF MDI · t-test, 2 sided · p = 0.0040 · Mean ratio to baseline: -0.50 · 95% CI -0.81 to -0.18Within-group comparison to baseline using paired test.

Adverse events

Collected over Adverse events were collected from visit 2 throughout the treatment period and including the follow-up period telephone call.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BGF MDI0/22 (0%)1/22 (4.5%)0/22 (0%)
GFF MDI0/23 (0%)0/23 (0%)2/23 (8.7%)
Most frequent serious events
Most frequent serious events
EventBGF MDIGFF MDI
Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/220/23
Most frequent other events
Most frequent other events
EventBGF MDIGFF MDI
DyspnoeaRespiratory, thoracic and mediastinal disorders0/222/23

Baseline characteristics

ITT Population - all subjects who were randomized to treatment.

Age, Continuous
Age, Continuous(Years)Overall Study
Mean64.9 ± 7.6
Sex: Female, Male
Sex: Female, Male(Participants)Overall Study
Female5
Male18
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Overall Study
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White23
More than one race0
Unknown or Not Reported0
08

Study locations

4 sites
  • Research Site
    Erpent, 5101, Belgium
  • Research Site
    Eindhoven, 5623 EJ, Netherlands
  • Research Site
    Groningen, 9713 GZ, Netherlands
  • Research Site
    Zutphen, 7207 AE, Netherlands
09

References and documents

Publications

  • 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. PubMed 34210340 ↗

Study documents

  • Study protocol · Jul 5, 2019
  • Statistical analysis plan · Aug 26, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03836677
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Feb 11, 2019
Start date
Feb 26, 2019
Primary completion
Nov 11, 2019
Completion
Nov 11, 2019
Results posted
Feb 11, 2021
Last update
Feb 11, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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