Trial Outcomes & Findings for ProAir Digihaler in COPD Disease Management: A Real World Study (NCT NCT04821869)

NCT ID: NCT04821869

Last Updated: 2025-06-13

Results Overview

Presence of a Peak Inspiratory Flow (PIF) alert prior to a COPD Exacerbation Peak Inspiratory Flow (PIF) is the maximal inspiratory flow achieved during each patient inhalation of the Digihaler dry powder inhaler. PIF is automatically measured by the Digihaler dry powder inhaler during every inspiration of medication by a subject. Inspiratory flow is used to inhale respiratory medications into the lungs. A low inspiratory flow rate has been considered to place a COPD patient at risk for reducing medication inhalation and for other adverse outcomes. An acute fall in a patient's PIF may also be a marker of an impending change in a patient's condition. All acute COPD exacerbations were assessed by patient history, diaries and direct patient interviews. If a COPD Exacerbation had occurred, PIF measurements in the prior 2 weeks were assessed to determine if a PIF Alert, defined as a 20% fall in PIF from baseline for a minimum of 2 consecutive days, had occurred in the 2 weeks prior.

• Recruitment status: COMPLETED
• Target enrollment: 27 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-06-13

Participant Flow

Recruitment initiated May 19, 2021. Study completed June 20, 2022. The study was conducted at a single clinical research center, the Pulmonary Research Institute of Southeast Michigan.

27 subjects were recruited and consented to enroll 20 subjects for 6 months of observation. 7 participants failed during run-in: 4 due to COPD exacerbation during run-in, 1 did not meet FEV1 entry criteria and 2 withdrew during run-in unrelated to study participation. All 20 participants enrolled in the study completed the study and were included in all analysis.Post study, subjects were stratified based on the occurrence of a COPD exacerbation during the study and analyzed accordingly.

Participant milestones

Measure	Digihaler Device User Single arm pilot study assessing the relationship of deterioration in COPD healthcare status (COPD exacerbations and/or worsening in COPD Assessment Test ≥2) to changes in physiologic parameters measured from usage of an albuterol Digihaler inhalation device, including peak inspiratory flow (PIF), extra inhaler puff usage per day and inhalation volume (InV) prior to any heaalthcare deterioration event.
Overall Study STARTED	27
Overall Study Post run-in Enrollment	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Digihaler Device User Single arm pilot study assessing the relationship of deterioration in COPD healthcare status (COPD exacerbations and/or worsening in COPD Assessment Test ≥2) to changes in physiologic parameters measured from usage of an albuterol Digihaler inhalation device, including peak inspiratory flow (PIF), extra inhaler puff usage per day and inhalation volume (InV) prior to any heaalthcare deterioration event.
Overall Study Adverse Event	4
Overall Study Withdrawal by Subject	2
Overall Study Did not meet FEV1 criteria	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Subjects With COPD Exacerbations n=11 Participants All subjects meeting inclusion exclusion criteria who had an exacerbation during the study	Subjects With no COPD Exacerbation n=9 Participants All subjects meeting inclusion exclusion criteria who did not have an exacerbation during the study	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=11 Participants	0 Participants n=9 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=11 Participants	5 Participants n=9 Participants	11 Participants n=20 Participants
Age, Categorical >=65 years	5 Participants n=11 Participants	4 Participants n=9 Participants	9 Participants n=20 Participants
Age, Continuous	66 years n=11 Participants	67 years n=9 Participants	67 years n=20 Participants
Sex: Female, Male Female	9 Participants n=11 Participants	3 Participants n=9 Participants	12 Participants n=20 Participants
Sex: Female, Male Male	2 Participants n=11 Participants	6 Participants n=9 Participants	8 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	11 participants n=11 Participants	9 participants n=9 Participants	20 participants n=20 Participants
Baseline PIF	73.6 L/min STANDARD_DEVIATION 23.2 • n=11 Participants	66.2 L/min STANDARD_DEVIATION 18.3 • n=9 Participants	70.3 L/min STANDARD_DEVIATION 21.0 • n=20 Participants

PRIMARY outcome

Timeframe: 6 months

Population: This was an observational study with one treatment arm using a single study drug during the 6 months of study. All acute COPD exacerbation events meeting Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria for an acute COPD exacerbation were assessed to determine if a PIF alert was present prior to the event. All subjects/ events were assessed as a treatment outcome (not a treatment arm).

Presence of a Peak Inspiratory Flow (PIF) alert prior to a COPD Exacerbation

Peak Inspiratory Flow (PIF) is the maximal inspiratory flow achieved during each patient inhalation of the Digihaler dry powder inhaler. PIF is automatically measured by the Digihaler dry powder inhaler during every inspiration of medication by a subject. Inspiratory flow is used to inhale respiratory medications into the lungs. A low inspiratory flow rate has been considered to place a COPD patient at risk for reducing medication inhalation and for other adverse outcomes. An acute fall in a patient's PIF may also be a marker of an impending change in a patient's condition.

All acute COPD exacerbations were assessed by patient history, diaries and direct patient interviews. If a COPD Exacerbation had occurred, PIF measurements in the prior 2 weeks were assessed to determine if a PIF Alert, defined as a 20% fall in PIF from baseline for a minimum of 2 consecutive days, had occurred in the 2 weeks prior.

Outcome measures

Measure	COPD Exacerbation n=22 COPD Exacerbations All events meeting GOLD criteria for an acute COPD exacerbation
PIF Alerts and COPD Exacerbations	2 Low PIF Alert

PRIMARY outcome

Timeframe: 6 months

Population: All worsening of CAT score events

Presence of a Low Peak Inspiratory Flow (PIF) alert, defined by an 20% reduction in PIF from baseline for a minimum of 2 consecutive days occurring in the 2 weeks prior to a worsening of a subject COPD Assessment Test Score (CAT, score range 0-40, clinically important difference defined as a change in CAT score of 2 or more over time with an increase in value identifying worsening disease).

Peak Inspiratory Flow (PIF) is the maximal inspiratory flow achieved during each patient inhalation of the Digihaler dry powder inhaler. PIF is automatically measured and recorded by the Digihaler device during every inspiration of medication with the device. All PIF measures in the 2 weeks prior to any worsening of CAT were assessed and a PIF alert was identified as being present if PIF fell by ≥20% from baseline on 2 or more consecutive days in the 2 weeks prior to a worsening of CAT score event.

Outcome measures

Measure	COPD Exacerbation n=40 Worsening of CAT All events meeting GOLD criteria for an acute COPD exacerbation
Low PIF Alerts and Worsening CAT Score	3 Low PIF Alert

SECONDARY outcome

Timeframe: 6 months

Population: All acute COPD exacerbation events meeting Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria for an acute COPD exacerbation.

Presence of a Rescue SABA Puff Use Alert, defined as an increase of 2 or more rescue inhaler puffs per day above baseline for 2 or more days in the 2 weeks prior to any COPD exacerbation. Rescue SABA Puff use is the counted and recorded use of the DIgihaler inhaler device each time the subject uses of the Digihaler device.

Outcome measures

Measure	COPD Exacerbation n=22 COPD Exacaerabations All events meeting GOLD criteria for an acute COPD exacerbation
Rescue SABA Puff Use Alerts and COPD Exacerbations	0 Rescue SABA Puff Use Alert

SECONDARY outcome

Timeframe: 6 months

Population: All acute COPD exacerbation events meeting Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria for an acute COPD exacerbation.

Presence of a Low Inhalation Volume (IV) alert, defined by a 20% fall in IV from baseline for 2 or more days in the 2 weeks prior to any COPD exacerbation. IV is the volume of air inhaled and measured during each patient inhalation use of the Digihaler device.

Outcome measures

Measure	COPD Exacerbation n=22 COPD exacerbation All events meeting GOLD criteria for an acute COPD exacerbation
Low IV Alerts and COPD Exacerbations	4 Low IV Alert

Adverse Events

Digihaler Device User

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure

Digihaler Device User n=27 participants at risk Single arm pilot study assessing the relationship of deterioration in COPD healthcare status (COPD exacerbations and/or worsening in COPD Assessment Test ≥2) to changes in physiologic parameters measured from usage of an albuterol Digihaler inhalation device, including peak inspiratory flow (PIF), extra inhaler puff usage per day and inhalation volume (InV) prior to any heaalthcare deterioration event.

Respiratory, thoracic and mediastinal disorders COPD Exacerbation

11.1% 3/27 • Number of events 4 • Data was collected from consent to post study follow-up over approximately 7 months All ad verse event descriptions and definitions are per clinicaltrials.gov

Other adverse events

Measure	Digihaler Device User n=27 participants at risk Single arm pilot study assessing the relationship of deterioration in COPD healthcare status (COPD exacerbations and/or worsening in COPD Assessment Test ≥2) to changes in physiologic parameters measured from usage of an albuterol Digihaler inhalation device, including peak inspiratory flow (PIF), extra inhaler puff usage per day and inhalation volume (InV) prior to any heaalthcare deterioration event.
Respiratory, thoracic and mediastinal disorders COPD Exacerbation	44.4% 12/27 • Number of events 18 • Data was collected from consent to post study follow-up over approximately 7 months All ad verse event descriptions and definitions are per clinicaltrials.gov
General disorders Non respiratory adverse events	44.4% 12/27 • Number of events 12 • Data was collected from consent to post study follow-up over approximately 7 months All ad verse event descriptions and definitions are per clinicaltrials.gov

Additional Information

Gary T Ferguson, MD, Director

Pulmonary Research Institute of Southeast MIchigan

Phone: 248-478-6908

Email: garytferguson@msn.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place