A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD
Summary
To assess the effect of treatment with Glycopyronnium (GP) MDI administered twice daily (BID) and Formoterol Fumarate (FF) MDI administered BID on specific image-based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) following chronic dosing after approximately two weeks treatment.
Timeline
- Start
- 2016-12-29
- Primary completion
- 2018-05-28
- Completion
- 2018-05-28
Outcome
Met primary endpoint
registry analysis (other test); GP MDI; p = 0.0187; Geometric mean ratio to baseline 1.11 (95% CI 1.02 to 1.22); t-test, 2 sided NCT02937584 ↗
registry analysis (other test); FF MDI; p <0.0001; Geometric mean ratio to baseline 1.23 (95% CI 1.14 to 1.33); t-test, 2 sided NCT02937584 ↗
registry analysis (other test); GP MDI; p = 0.0219; Geometric mean ratio to baseline 0.75 (95% CI 0.59 to 0.95); t-test, 2 sided NCT02937584 ↗
registry analysis (other test); FF MDI; p <0.0001; Geometric mean ratio to baseline 0.56 (95% CI 0.44 to 0.71); t-test, 2 sided NCT02937584 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Formoterol | Other / unclassified | 9.6 ug | Inhaled |
| Subject | Glycopyrronium | Unknown | 14.4 ug | Inhaled |