Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT03836677

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 study testing BGF and GFF in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: BGF and GFF
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 4 sitesin 2 countries
Study dates: 26 Feb 2019to 11 Nov 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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:
Subjects who cannot perform acceptable spirometry, i.e., meet ATS/ERS acceptability criteria.
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

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Netherlands3 sites

Research Site
Eindhoven, 5623 EJ
Research Site
Groningen, 9713 GZ
Research Site
Zutphen, 7207 AE

Other trials in Netherlands

Belgium1 site

Research Site
Erpent, 5101

Other trials in Belgium

About this study

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

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).

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: BGF, GFF
Keywords: COPD
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BGFCombination product
Treatment with Budesonide/Glycopyrronium/FormoterolFumarate
GFFCombination product
Treatment with Glycopyrronium/Formoterol Fumarate

Study groups in NCT03836677
Study group	Role	What they receive
BGF-GFF	Experimental	Subject first treated with Budesonide/Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Glycopyrronium/Formoterol Fumarate Receives: Combination Product: BGF; Combination Product: GFF
GFF-BGF	Experimental	Subject first treated with Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Budesonide/Glycopyrronium/Formoterol Fumarate Receives: Combination Product: BGF; Combination Product: GFF

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Day 29
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.
Measured: Baseline, Day 29

Secondary outcomes (4)

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.
Measured: Baseline, Day 29
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.
Measured: Baseline, 29 Days
Forced Expiratory Volume in One Second (Post-dose FEV1).
Change from baseline in Forced Expiratory Volume in One Second (Post-dose FEV1).
Measured: Baseline 29 Days
Functional Residual Capacity (FRC)
Change from baseline in Functional residual capacity (FRC).
Measured: Baseline, Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Feb 201911 Nov 2019

First posted11 Feb 2019
Study start26 Feb 2019
Primary completion11 Nov 2019
Study completion11 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03836677
Sponsor's protocol ID: D5980C00019
Status last verified: Jan 2021
First submitted: 24 Sep 2018
Last updated: 11 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03836677
Acronym / sponsor ID: D5980C00019
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 26 Feb 2019 (actual)
Primary completion: 11 Nov 2019 (actual)
Study completion: 11 Nov 2019 (actual)
First posted: 11 Feb 2019 (actual)
Results: Posted 11 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
BGF-GFF	Experimental	Combination Product: BGF, Combination Product: GFFSubject first treated with Budesonide/Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Glycopyrronium/Formoterol Fumarate
GFF-BGF	Experimental	Combination Product: BGF, Combination Product: GFFSubject first treated with Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Budesonide/Glycopyrronium/Formoterol Fumarate

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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:
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BGFTreatment with Budesonide/Glycopyrronium/FormoterolFumarate	Combination product	BGF-GFF, GFF-BGF
GFFTreatment with Glycopyrronium/Formoterol Fumarate	Combination product	BGF-GFF, GFF-BGF

Primary outcome

Specific Image-based Airway Volume (siVaw)
Time frame: 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)
Time frame: 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.

4 secondary outcomes

Image-based Airway Volume (iVaw)
Time frame: Baseline, Day 29
Image-based Airway Resistance (iRaw)
Time frame: Baseline, 29 Days
Forced Expiratory Volume in One Second (Post-dose FEV1).
Time frame: Baseline 29 Days
Functional Residual Capacity (FRC)
Time frame: Baseline, Day 29

Results and safety

Results posted to the registry on 11 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BGF MDI/GFF MDI	13	13
GFF MDI/BGF MDI	10	9

Primary outcome: Specific Image-based Airway Volume (siVaw)

Time frame: Baseline, Day 29. Geometric mean (95% Confidence Interval). Unit: Ratio to baseline

Measure	BGF MDI n = 20	GFF MDI n = 21
Value	1.72 (1.38 to 2.13)	1.53 (1.28 to 1.83)

BGF MDI: Geometric Mean ratio to baseline: 1.72 (95% CI 1.38 to 2.13), p <0.0001, t-test, 2 sided
GFF MDI: Geometric mean ratio to baseline: 1.53 (95% CI 1.28 to 1.83), p <0.0001, t-test, 2 sided

Population analysed: ITT Population

Primary outcome: Specific Image-based Airway Resistance (siRaw)

Time frame: Baseline, Day 29. Geometric mean (95% Confidence Interval). Unit: Ratio to baseline

Measure	BGF MDI n = 20	GFF MDI n = 21
Value	0.50 (0.39 to 0.63)	0.52 (0.40 to 0.67)

BGF MDI: Geometric mean ratio to baseline: 0.50 (95% CI 0.39 to 0.63), p <0.0001, t-test, 2 sided
GFF MDI: Geometric mean ratio to baseline: 0.52 (95% CI 0.40 to 0.67), p <0.0001, t-test, 2 sided

Population analysed: ITT Population

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from visit 2 throughout the treatment period and including the follow-up period telephone call.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BGF MDI	1 of 22 (4.5%)	0 of 22 (0%)	0 of 22
GFF MDI	0 of 23 (0%)	2 of 23 (8.7%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34210340van 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.
Statistical Analysis Plan (SAP)Link provided by the sponsor.
CSPLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BGF and GFF in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Specific Image-based Airway Volume (siVaw) (time frame: Baseline, Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03836677, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.