Trial Outcomes & Findings for Digihaler in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT05241288)

Last Updated: 2024-01-23

Results Overview

PIF is the maximal flow occurring during an inhalation effort, expressed in Liters/minute. Mean and standard deviation of daily PIF measurement collected over three months will be calculated. PIF will be measured using the Digihaler device.

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

3 months

Results posted on

2024-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	Albuterol eMDPI DS (ProAir® Digihaler®) This arm will receive the intervention of the Albuterol eMDPI DS for three months. Albuterol eMDPI DS: Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) with 3 component devices: Device 1: Albuterol eMDPI Device 2: Albuterol eMDPI Patient-facing smart device application (App) Device 3: Digital Health Platform (DHP, Cloud solution)
Overall Study STARTED	54
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Digihaler in Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Albuterol eMDPI DS (ProAir® Digihaler®) n=40 Participants This arm will receive the intervention of the Albuterol eMDPI DS for three months. Albuterol eMDPI DS: Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) with 3 component devices: Device 1: Albuterol eMDPI Device 2: Albuterol eMDPI Patient-facing smart device application (App) Device 3: Digital Health Platform (DHP, Cloud solution)
Age, Continuous	62.5 years STANDARD_DEVIATION 7.95 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 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	6 Participants n=5 Participants
Race (NIH/OMB) White	33 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	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Albuterol eMDPI DS (ProAir® Digihaler®) n=40 Participants This arm will receive the intervention of the Albuterol eMDPI DS for three months. Albuterol eMDPI DS: Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) with 3 component devices: Device 1: Albuterol eMDPI Device 2: Albuterol eMDPI Patient-facing smart device application (App) Device 3: Digital Health Platform (DHP, Cloud solution)
Mean Variability in Peak Inspiratory Flow (PIF)	67.6 Liters/minute Standard Deviation 20.3

PRIMARY outcome

Timeframe: 3 months

PIF is the maximal flow occurring during an inhalation effort, expressed in Liters/minute. Coefficient of variation (calculated by dividing standard deviation of PIF by the mean of the PIF) of daily PIF measurement collected over three months will be calculated. PIF will be measured using the Digihaler device.

Outcome measures

Outcome measures
Measure	Albuterol eMDPI DS (ProAir® Digihaler®) n=40 Participants This arm will receive the intervention of the Albuterol eMDPI DS for three months. Albuterol eMDPI DS: Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) with 3 component devices: Device 1: Albuterol eMDPI Device 2: Albuterol eMDPI Patient-facing smart device application (App) Device 3: Digital Health Platform (DHP, Cloud solution)
Variability in Peak Inspiratory Flow (PIF) as Measured by Coefficient of Variation	0.286 Correlation coefficient Interval 0.246 to 0.325

SECONDARY outcome

Timeframe: 3 months

Correlation between self-reported inhaler use and actual inhaler use over three months will be calculated with Spearman rank-order correlation coefficient. Self-reported inhaler use will be determined with an investigator-developed single question categorizing average use over the last four weeks with five groups (not at all, once a week or less, two or three times a week, one or two times a day, three or more times a day). Actual inhaler use will be directly measured via Digihaler device and categorized into one of the five groups described above.

Outcome measures

Outcome measures
Measure	Albuterol eMDPI DS (ProAir® Digihaler®) n=40 Participants This arm will receive the intervention of the Albuterol eMDPI DS for three months. Albuterol eMDPI DS: Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) with 3 component devices: Device 1: Albuterol eMDPI Device 2: Albuterol eMDPI Patient-facing smart device application (App) Device 3: Digital Health Platform (DHP, Cloud solution)
Correlation of Self-Reported Inhaler Use With Actual Inhaler Use	-0.385 Correlation coefficient Interval -0.413 to -0.357

SECONDARY outcome

Timeframe: 3 months

Inhalation volume is the volume of air inspired during an inhalation effort, expressed in Liters. The mean and standard deviation of daily inhalation volume measurements collected daily over three months will be calculated. Inhalation volume will be measured using the Digihaler device.

Outcome measures

Outcome measures
Measure	Albuterol eMDPI DS (ProAir® Digihaler®) n=40 Participants This arm will receive the intervention of the Albuterol eMDPI DS for three months. Albuterol eMDPI DS: Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) with 3 component devices: Device 1: Albuterol eMDPI Device 2: Albuterol eMDPI Patient-facing smart device application (App) Device 3: Digital Health Platform (DHP, Cloud solution)
Mean Variability in Inhalation Volume	1.395 Liters Standard Deviation 0.598

SECONDARY outcome

Timeframe: 3 months

Inhalation volume is the volume of air inspired during an inhalation effort, expressed in Liters. Coefficient of variation (calculated by dividing standard deviation of inhalation volume by the mean of the inhalation volume) of daily inhalation volume measurement collected over three months will be calculated.

Outcome measures

Outcome measures
Measure	Albuterol eMDPI DS (ProAir® Digihaler®) n=40 Participants This arm will receive the intervention of the Albuterol eMDPI DS for three months. Albuterol eMDPI DS: Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) with 3 component devices: Device 1: Albuterol eMDPI Device 2: Albuterol eMDPI Patient-facing smart device application (App) Device 3: Digital Health Platform (DHP, Cloud solution)
Variability in Inhalation Volume as Measured by Coefficient of Variation	0.426 Correlation coefficient Interval 0.366 to 0.485

Adverse Events

Albuterol eMDPI DS (ProAir® Digihaler®)

Serious events: 5 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Albuterol eMDPI DS (ProAir® Digihaler®) n=54 participants at risk This arm will receive the intervention of the Albuterol eMDPI DS for three months. Albuterol eMDPI DS: Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) with 3 component devices: Device 1: Albuterol eMDPI Device 2: Albuterol eMDPI Patient-facing smart device application (App) Device 3: Digital Health Platform (DHP, Cloud solution)
Respiratory, thoracic and mediastinal disorders COPD Exacerbation with hospitalization	7.4% 4/54 • Number of events 4 • From signing of informed consent throughout duration of study, a total of approximately 3 months.
Respiratory, thoracic and mediastinal disorders Metastatic Lung Cancer	1.9% 1/54 • Number of events 1 • From signing of informed consent throughout duration of study, a total of approximately 3 months.

Other adverse events

Other adverse events
Measure	Albuterol eMDPI DS (ProAir® Digihaler®) n=54 participants at risk This arm will receive the intervention of the Albuterol eMDPI DS for three months. Albuterol eMDPI DS: Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) with 3 component devices: Device 1: Albuterol eMDPI Device 2: Albuterol eMDPI Patient-facing smart device application (App) Device 3: Digital Health Platform (DHP, Cloud solution)
Respiratory, thoracic and mediastinal disorders COPD Exacerbation	7.4% 4/54 • Number of events 4 • From signing of informed consent throughout duration of study, a total of approximately 3 months.
Nervous system disorders Tremors	1.9% 1/54 • Number of events 1 • From signing of informed consent throughout duration of study, a total of approximately 3 months.
Skin and subcutaneous tissue disorders Oral Candidiasis	1.9% 1/54 • Number of events 1 • From signing of informed consent throughout duration of study, a total of approximately 3 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.7% 2/54 • Number of events 2 • From signing of informed consent throughout duration of study, a total of approximately 3 months.

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