Phase 3
Completed N=20
Effects of Bevespi on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI
Source: ClinicalTrials.gov NCT03324607 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Ventilation Distribution as Measured by Ventilation Defect+Low Percent — 57.8; 52.5 percentage of total ventilation — p=0.006
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to determine whether the new inhaler, Bevespi improves lung function. Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, that can provide useful images of the functioning of the lung will be used as a new measure to determine change in function. The investigator anticipate these images will provide more specific information about lung disease than standard lung function tests in response to treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ventilation Distribution as Measured by Ventilation Defect+Low Percent |
57.8; 52.5 | 0.006 sig |
| PRIMARY Barrier Uptake. |
13; 4 | — |
| PRIMARY Red Blood Cell (RBC) Uptake |
10; 7 | — |
| SECONDARY Pulmonary Function Test - Forced Vital Capacity (FVC) |
342 | — |
| SECONDARY Pulmonary Function Test - Forced Expiratory Volume-one Second (FEV1) |
219 | — |
| SECONDARY Pulmonary Function Test - Total Lung Capacity (TLC) |
183 | — |
| SECONDARY Pulmonary Function Test - Residual Volume (RV) |
-108 | — |
| SECONDARY Pulmonary Function Test - Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) |
0.2 | — |
| SECONDARY 6-minute Walk Test (6MWT) |
16.2 | — |
| SECONDARY St. George's Respiratory Questionnaire (SGRQ) Score |
-1.2 | — |
| SECONDARY Rating of Perceived Dyspnea (RPD) Scale |
-0.75 | — |
| SECONDARY COPD Assessment Test (CAT) Score |
-3.8 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of COPD confirmed by post-bronchodilator spirometry demonstrating (forced expiratory volume at 1 second(FEV1)/forced vital capacity (FVC) 10 mg/day of prednisone
- Chronic oxygen use (intermittent or continuous)
- Previous lung resection surgery or decortication
- Previous history of pneumothorax
- Evidence of interstitial, occupational or chronic infectious lung disease by imaging studies
- History of exposure to occupational or environmental hazards that are known to cause lung diseases
- For women of child bearing potential, positive pregnancy test
- Major chronic illnesses which in the judgement of the study physician would interfere with participation in the study
- Patients who are not willing to withhold COPD inhalers for the run-in period.
- MRI is contraindicated based on responses to MRI screening questionnaire
- Subject is pregnant or lactating
- Respiratory illness of a bacterial or viral etiology within 30 days of MRI
- Subject has any form of known cardiac arrhythmia
- Subject does not fit into 129Xe vest coil used for MRI
- Subject cannot hold his/her breath for 15 seconds
- Subject deemed unlikely to be able to comply with instructions during imaging
Data sourced from ClinicalTrials.gov (NCT03324607). 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.