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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

NCT ID: NCT03836677

Last Updated: 2021-02-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2019-11-11

Brief Summary

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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.

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Detailed Description

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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

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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BGF-GFF

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

Group Type EXPERIMENTAL

BGF

Intervention Type COMBINATION_PRODUCT

Treatment with Budesonide/Glycopyrronium/FormoterolFumarate

GFF

Intervention Type COMBINATION_PRODUCT

Treatment with Glycopyrronium/Formoterol Fumarate

GFF-BGF

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

Group Type EXPERIMENTAL

BGF

Intervention Type COMBINATION_PRODUCT

Treatment with Budesonide/Glycopyrronium/FormoterolFumarate

GFF

Intervention Type COMBINATION_PRODUCT

Treatment with Glycopyrronium/Formoterol Fumarate

Interventions

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BGF

Treatment with Budesonide/Glycopyrronium/FormoterolFumarate

Intervention Type COMBINATION_PRODUCT

GFF

Treatment with Glycopyrronium/Formoterol Fumarate

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Erpent, , Belgium

Site Status

Research Site

Eindhoven, , Netherlands

Site Status

Research Site

Groningen, , Netherlands

Site Status

Research Site

Zutphen, , Netherlands

Site Status

Countries

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Belgium Netherlands

References

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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.

Reference Type DERIVED
PMID: 34210340 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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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=

Statistical Analysis Plan (SAP)

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=

CSP

Other Identifiers

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D5980C00019

Identifier Type: -

Identifier Source: org_study_id

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