Phase 3
Completed N=23
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
Source: ClinicalTrials.gov NCT03836677 ↗Enrolled (actual)
23
Serious AEs
2.2%
Results posted
Feb 2021
Primary outcomePrimary: Specific Image-based Airway Volume (siVaw) — 1.72; 1.53 Ratio to baseline — p=<0.0001
◆ Published Evidence
Emerging
19citations · ~4 / year
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.
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.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Specific Image-based Airway Volume (siVaw) |
1.72; 1.53 | <0.0001 sig |
| PRIMARY Specific Image-based Airway Resistance (siRaw) |
0.50; 0.52 | <0.0001 sig |
| SECONDARY Image-based Airway Volume (iVaw) |
1.70; 1.51 | <0.0001 sig |
| SECONDARY Image-based Airway Resistance (iRaw) |
0.50; 0.52 | <0.0001 sig |
| SECONDARY Forced Expiratory Volume in One Second (Post-dose FEV1). |
0.346; 0.273 | 0.0003 sig |
| SECONDARY Functional Residual Capacity (FRC) |
-0.28; -0.50 | 0.2515 |
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
Data sourced from ClinicalTrials.gov (NCT03836677) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.