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NCT Number: NCT03836677

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

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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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Erpent, Belgium

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BGF

Combination Product

Treatment with Budesonide/Glycopyrronium/FormoterolFumarate

GFF

Combination Product

Treatment with Glycopyrronium/Formoterol Fumarate

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Image-based Airway Volume (iVaw)

    Time frame: Baseline, Day 29

    Image-based Airway Volume (iVaw) measured in mL. Average across lobes, without adjustment for lobe volume. Reported as ratio to baseline.

  2. Image-based Airway Resistance (iRaw)

    Time frame: Baseline, 29 Days

    Image-based airway resistance (iRaw) measured in kPa∙s/L. Average across lobes, without adjustment for lobe volume. Reported as ratio to baseline.

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

    Time frame: Baseline 29 Days

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

  4. Functional Residual Capacity (FRC)

    Time frame: Baseline, Day 29

    Change from baseline in Functional residual capacity (FRC).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 11, 2019
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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