N/A
N=80
Peak Inspiratory Flow Rates in Patients With COPD
COPD
Bottom Line
View on ClinicalTrials.gov: NCT04168775 ↗Enrolled (actual)
80
Serious AEs
27.5%
Results posted
Sep 2022
Primary outcome: Primary: Occurrence of Suboptimal PIFR — 22.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Home PIFR monitoring with InCheck Dial (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Suboptimal PIFR |
22.7 | — |
Summary
Recent studies have reported that some Chronic Obstructive Pulmonary Disease (COPD) patients may have a suboptimal ability to generate a sufficient inspiratory effort to achieve adequate lung delivery of inhaled medications through dry powder inhalers. Sparse data is available about the inspiratory capacity of these patients in the home setting, whether clinically stable or when experiencing worsened respiratory symptoms outside the acute care setting. This study is undertaken to better understand the proportion of patients with suboptimal peak inspiratory flow rate (sPIFR) measurements amongst COPD patients receiving dry powder inhaler(s) (DPI) in the ambulatory setting. Further, the study will characterize PIFR over time, the variability of PIFR measurements, and the associations with potential predictors (demographics, clinical, Patient-Reported Outcomes (PRO), body position, and device) as well as exacerbations frequency and change in PIFR around period of exacerbation.
Eligibility Criteria
Inclusion Criteria
- Age > 50 years-old
- Spirometry-confirmed diagnosis of COPD (FEV1/FVC 10
- For high resistance DPI, baseline PIFR =30 L/min; for medium resistance DPI, PIFR ≤ 90 L/min (InCheck DIAL®) and >=60 L/min. Handihaler is a high resistance DPI. Examples of medium resistance DPI: Anoro, Incruse, Breo Ellipta®, Advair® Diskus® DP or Wixela® Inhub®
- History of smoking tobacco products > 10 pack years
- Prescribed at least one daily maintenance DPI with no change in prescription within the four weeks prior to the Enrollment Visit
- One or more exacerbations of COPD requiring systemic corticosteroids within last 2 years
Exclusion Criteria
- Inability to demonstrate proper technique for the InCheck DIAL® device
- Inability to achieve minimum PIFR for prescribed DPI(s) at screening/enrollment visit (< 30 L/min for e.g., Handihaler® (High resistance DPI), < 60 L/min for Ellipta® (Medium resistance DPI))
- Inability to perform spirometry to meet American Thoracic Society standards
- Neuromuscular disease associated with weakness
- Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study.
- Pneumothorax within the past 4 weeks
- For those participants who will require spirometry (i.e., if they have not had it within the past 3 months): Participants who present with a myocardial infarction or eye, chest or abdominal surgery within six weeks of baseline can be rescreened after the six week window has passed
Data sourced from ClinicalTrials.gov (NCT04168775). 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.