Clinical trial NCT04606394: Peak Inspiratory Flow and Dry Powder Inhaler Performance in COPD
Official title: Peak Inspiratory Flow (PIF) and Dry Powder Inhaler (DPI) Performance in Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Keywords: DPI
PIF
FEV1
Lead sponsor: Pulmonary Research Institute of Southeast Michigan
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2020-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label comparative design
Primary purpose: TREATMENT

Brief 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

Detailed description: Study Design and Methods Rationale

* The expected FEV1 response to a bronchodilator is uncertain as multiple factors influence this measure, including severity of disease, day to day variability, varying reversibility in COPD patients, the delivery of the drug to a patient and the effectiveness of the medication delivered. Thus, the measurement of an acute bronchodilator response after delivering a long acting bronchodilator may not identify whether a medication has been effectively delivered to a patient.
* However, if a long acting bronchodilator has not been effectively delivered to the lung, then subsequent delivery of a short acting bronchodilator should produce a significant additional bronchodilator response. On the other hand, if a long acting bronchodilator has been effectively delivered to the lung, then subsequent delivery of a short acting bronchodilator should not produce any further significant bronchodilation.
* Based on this rationale, comparison of the acute bronchodilator response to a short acting bronchodilator after receiving a long acting should identify whether drug delivery is ineffective in a selected patient population, irrespective of baseline FEV1 and of any partial response to the long acting bronchodilator. Comparison of the short acting bronchodilator measurement between patient groups with differing PIF thresholds should identify whether PIF has an impact of drug delivery of a long acting bronchodilator via a DPI.
* Open label design comparing the acute bronchodilator response after delivery of a long acting bronchodilator via Ellipta DPI in patients with normal, suboptimal and minimal PIF.

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)

Primary outcomes:
measure: DPI Responder Analysis in Patients With Suboptimal PIF (<60 L/Min)
timeFrame: 2 weeks
Secondary outcomes:
measure: DPI Responder Analysis in Patients With Reduced PIF (<45 L/Min)
timeFrame: 2 weeks
measure: PIF Measurement Techniques
timeFrame: Baseline on day of testing
Other outcomes:
Locations:
city: Farmington Hills
country: United States
facility: Pulmonary Research Institute of Southeast Michigan
state: Michigan
Study officials:
affiliation: Pulmonary Research Institute of Southeast Michigan
name: Gary T Ferguson, MD
role: PRINCIPAL_INVESTIGATOR
References: