Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

BGF

GFF

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

BGF-GFF

GFF-BGF

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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

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

Functional Residual Capacity (FRC)

Change from baseline in Functional residual capacity (FRC).

Full Information

NCT ID

NCT03836677

First Posted

September 24, 2018

Last Updated

January 25, 2021

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT03836677

Brief Title

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

February 26, 2019 (Actual)

Primary Completion Date

November 11, 2019 (Actual)

Study Completion Date

November 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BGF-GFF

Arm Type

Experimental

Arm Description

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

Arm Title

GFF-BGF

Arm Type

Experimental

Arm Description

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

Intervention Type

Combination Product

Intervention Name(s)

BGF

Intervention Description

Treatment with Budesonide/Glycopyrronium/FormoterolFumarate

Intervention Type

Combination Product

Intervention Name(s)

GFF

Intervention Description

Treatment with Glycopyrronium/Formoterol Fumarate

Primary Outcome Measure Information:

Title

Specific Image-based Airway Volume (siVaw)

Description

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

Title

Specific Image-based Airway Resistance (siRaw)

Description

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 Outcome Measure Information:

Title

Image-based Airway Volume (iVaw)

Description

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

Title

Image-based Airway Resistance (iRaw)

Description

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

Title

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

Description

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

Time Frame

Baseline 29 Days

Title

Functional Residual Capacity (FRC)

Description

Change from baseline in Functional residual capacity (FRC).

Time Frame

Baseline, Day 29

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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: 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

Facility Information:

Facility Name

Research Site

City

Erpent

ZIP/Postal Code

5101

Country

Belgium

Facility Name

Research Site

City

Eindhoven

ZIP/Postal Code

5623 EJ

Country

Netherlands

Facility Name

Research Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Research Site

City

Zutphen

ZIP/Postal Code

7207 AE

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

34210340

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.

Results Reference

derived

Links:

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5980C00019&attachmentIdentifier=a5d5dc54-7197-4031-9e83-0480baeaa3f2&fileName=d5980c00019-sap-ed-2_Redacted.pdf&versionIdentifier=

Description

Statistical Analysis Plan (SAP)

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5980C00019&attachmentIdentifier=603a22eb-76ce-4e33-af2d-84d7b45e7bb8&fileName=d5980c00019-csp-v3_Redacted-v1.pdf&versionIdentifier=

Description

CSP

Learn more about this trial

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

We'll reach out to this number within 24 hrs