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

NCT03836677 | Completed Phase 3 Results FDA Drug

• 1 other identifier: D5980C00019
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 4

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Day 29

Secondary Outcomes (4)

• Image-based Airway Volume (iVaw)

  Baseline, Day 29

• Image-based Airway Resistance (iRaw)

  Baseline, 29 Days

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

  Baseline 29 Days

• Functional Residual Capacity (FRC)

  Baseline, Day 29

Study Arms (2)

BGF-GFF

EXPERIMENTAL

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

GFF-BGF

EXPERIMENTAL

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

BGF COMBINATION_PRODUCT

Treatment with Budesonide/Glycopyrronium/FormoterolFumarate

BGF-GFF; GFF-BGF

GFF COMBINATION_PRODUCT

Treatment with Glycopyrronium/Formoterol Fumarate

BGF-GFF; GFF-BGF

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Erpent, 5101, Belgium

Location

Research Site

Eindhoven, 5623 EJ, Netherlands

Location

Research Site

Groningen, 9713 GZ, Netherlands

Location

Research Site

Zutphen, 7207 AE, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 34210340 DERIVED

Related Links

• Statistical Analysis Plan (SAP)
• CSP

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: AstraZeneca AB
• Organization: AstraZeneca AB

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: February 11, 2019
• Study Start: February 26, 2019
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: February 11, 2021
• Results First Posted: February 11, 2021

Record last verified: 2021-01

Locations

BE (1); NL (3)