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Peak Inspiratory Flow Rates in Patients With COPD

NCT04168775 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-09-21

Study results available
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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.

Conditions

Interventions

DEVICE

Home PIFR monitoring with InCheck Dial

The In-Check G16 DIAL® (Alliance Tech Medical, Granbury TX) is a simple hand-held device that measures PIFR via a brief inspiratory maneuver.

Sponsors & Collaborators

Principal Investigators

  • Michael B Drummond, MD · University of North Carolina, Chapel Hill

  • Ashley Henderson, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2022-04-26
Completion
2022-04-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04168775 on ClinicalTrials.gov