Phase 4
N=45
Peak Inspiratory Flow and Dry Powder Inhaler Performance in COPD
COPD
Bottom Line
View on ClinicalTrials.gov: NCT04606394 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: DPI Responder Analysis in Patients With Suboptimal PIF (<60 L/Min) — 2; 1 Number of subject test days — p=0.33
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Trelegy Ellipta 100/62.5/25Mcg Inh 30D (Drug); Ventolin 90Mcg/Actuation Inhalation Aerosol (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Pulmonary Research Institute of Southeast Michigan
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY DPI Responder Analysis in Patients With Suboptimal PIF (<60 L/Min) |
2; 1 | 0.33 |
| SECONDARY DPI Responder Analysis in Patients With Reduced PIF (<45 L/Min) |
2; 1 | 0.04 sig |
| SECONDARY PIF Measurement Techniques |
52; 53; 70; 74; 137 | — |
Summary
The purpose of the study is to determine whether PIF is clinically important when using the Ellipta DPI device. In addition, the study will validate the best/most clinically appropriate way to perform a PIF maneuver, to determine the testing capabilities of the preferred PIF maneuver and to relate this PIF measurement to meaningful clinical outcomes in COPD patients
Eligibility Criteria
Inclusion Criteria
- smoking history >10 pack years
- pre-bronchodilator FEV1 <60% predicted
- post-bronchodilator FEV1/FVC <70%
- female participants are eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions applies:
- not a woman of childbearing potential OR
- agree to follow the contraceptive guidance during the treatment period and until the safety follow-up contact after the last dose of study treatment
- stratification requiring at least 1/3 of patients having a PIF of < 60L/min (AM pre-dose based on using the level 2 InCheck Dial resistance setting with a sharp maximal effort starting after exhaling fully)
Exclusion Criteria
- any subject with unstable disease, including
- COPD exacerbation in the last 6 weeks
- upper respiratory tract in in the last 4 weeks
- COPD or upper respiratory tract infection during run-in (subjects may be re-screened x 1 when stable after an acute event)
- pulmonary disease other than COPD
- any lung resection
- unstable cardiac conditions (at the discretion of the investigator)
- other unstable medical conditions (at the discretion of the investigator)
Data sourced from ClinicalTrials.gov (NCT04606394). 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.