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Peak Inspiratory Flow Rates in Patients With COPD

Primary Purpose

COPD

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Home PIFR monitoring with InCheck Dial

About this trial

This is an interventional other trial for COPD focused on measuring peak inspiratory flow rate

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Sites / Locations

University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Home PIFR monitoring

Arm Description

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

Outcomes

Primary Outcome Measures

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))

Secondary Outcome Measures

Full Information

NCT ID

NCT04168775

First Posted

November 14, 2019

Last Updated

August 29, 2022

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT04168775

Brief Title

Peak Inspiratory Flow Rates in Patients With COPD

Official Title

A Single Center, Open Label, Prospective Study Measuring Proportion of Patients With Suboptimal Peak Inspiratory Flow Rate (sPIFR) Over 24 Weeks in an Ambulatory Setting Among Moderate to Very Severe COPD Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

July 31, 2019 (Actual)

Primary Completion Date

April 26, 2022 (Actual)

Study Completion Date

April 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Recent studies have reported that some 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 undertaking this study 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, PRO, body position, and device) as well as exacerbations frequency and change in PIFR around period of exacerbation. To complete these aims, 120 participants will be enrolled in a 6 month study to perform PIFR measurements and respiratory questionnaires at home.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD

Keywords

peak inspiratory flow rate

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Home PIFR monitoring

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Home PIFR monitoring with InCheck Dial

Intervention Description

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

Primary Outcome Measure Information:

Title

Occurrence of Suboptimal PIFR

Description

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael B Drummond, MD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ashley Henderson, MD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Peak Inspiratory Flow Rates in Patients With COPD

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