Peak Inspiratory Flow (PIF) in COPD

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pulmonary Research Institute of Southeast Michigan
• Collaborator: GlaxoSmithKline
• Treatments: Albuterol

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)