Trial Outcomes & Findings for Peak Inspiratory Flow Rates in Patients With COPD (NCT NCT04168775)

Last Updated: 2022-09-21

Results Overview

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))

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

24 weeks

Results posted on

2022-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	Home PIFR Monitoring 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 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.
Overall Study STARTED	80
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Peak Inspiratory Flow Rates in Patients With COPD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Home PIFR Monitoring n=80 Participants 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 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.
Age, Continuous	65.1 years STANDARD_DEVIATION 8.78 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	80 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	69 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	80 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Data are reported for all participants who contributed at least 2 consecutive PIFR measurements on different days.

Outcome measures

Outcome measures
Measure	Home PIFR Monitoring n=75 Participants 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 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.
Occurrence of Suboptimal PIFR	22.7 percentage of participants Interval 13.8 to 33.8

Adverse Events

Home PIFR Monitoring

Serious events: 22 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Home PIFR Monitoring n=80 participants at risk 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 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.
Respiratory, thoracic and mediastinal disorders COPD Exacerbation leading to Hospitalization	27.5% 22/80 • Number of events 35 • From Screening when participants signed Informed Consent through last completed study visit, a total of up to approximately 6 months.

Other adverse events

Adverse event data not reported

Additional Information

Michael B. Drummond, MD

University of North Carolina at Chapel Hill

Phone: 919-966-7054

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place