Peak Inspiratory Flow Rates in Patients With COPD

NCT04168775 | Completed Results FDA Device

• 1 other identifier: 19-0450
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

COPD

Keywords

peak inspiratory flow rate

Outcome Measures

Primary Outcomes (1)

• Occurrence of Suboptimal PIFR

  The occurrence of suboptimal Peak Inspiratory Flow Rate (sPIFR) over 24 weeks. sPIFR will be defined as any two consecutive measurements on different days below the optimal threshold for any prescribed DPI (e.g.,\<30 L/min for Handihaler® (High resistance DPI), \<60 L/min for Ellipta® (Medium resistance DPI))

  24 weeks

Study Arms (1)

Home PIFR monitoring

OTHER

Measurement of PIFR using the InCheck Dial® device and quantification of respiratory symptoms and COPD exacerbations using standardized questionnaires in the patient's home setting and during research visits in the clinic setting

Device: Home PIFR monitoring with InCheck Dial

Interventions

Home PIFR monitoring with InCheck Dial DEVICE

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

Home PIFR monitoring

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 50 years-old
• Spirometry-confirmed diagnosis of COPD (FEV1/FVC \<0.70)
• Global initiative for Chronic Obstructive Lung Disease (GOLD) II-IV based on spirometry results
• COPD Assessment Test (CAT) score \> 10
• For high resistance DPI, baseline PIFR \< 90 L/min (InCheck DIAL®) and \>=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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (2)

• Pleasants RA, Shaikh A, Henderson AG, Bayer V, Drummond MB. Changes in Peak Inspiratory Flow After Acute Bronchodilation: An Observational Study of Patients with Stable Chronic Obstructive Pulmonary Disease. J Aerosol Med Pulm Drug Deliv. 2024 Aug;37(4):171-179. doi: 10.1089/jamp.2023.0045. Epub 2024 May 29.

  PMID: 38814000 DERIVED

• Pleasants RA, Henderson AG, Bayer V, Shaikh A, Drummond MB. Effect on Physical Position of Peak Inspiratory Flow in Stable COPD: An Observational Study. Chronic Obstr Pulm Dis. 2024 Mar 26;11(2):174-186. doi: 10.15326/jcopdf.2023.0460.

  PMID: 38236166 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michael B. Drummond, MD
• Organization: University of North Carolina at Chapel Hill

brad_drummond@med.unc.edu

919-966-7054

Study Officials

• Michael B Drummond, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Ashley Henderson, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 19, 2019
• Study Start: July 31, 2019
• Primary Completion: April 26, 2022
• Study Completion: April 26, 2022
• Last Updated: September 21, 2022
• Results First Posted: September 21, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)