Digihaler in Chronic Obstructive Pulmonary Disease (COPD)

  • STATUS
    Recruiting
  • End date
    Dec 26, 2022
  • participants needed
    60
  • sponsor
    University of North Carolina, Chapel Hill
Updated on 26 April 2022

Summary

This is a multi-center 3-month study to determine the variation in ProAir Digihaler metrics [peak inspiratory flow (PIF), inhalation volume, number of inhalation events] amongst COPD patients in the ambulatory setting.

Description

The albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) (ProAir® Digihaler®) is the first and only Food and Drug Administration (FDA) approved inhaler rescue medication with a built-in sensor to detect and record inhaler use. The inhaler device measures PIF and the app groups PIF into categories that can help to highlight potential patient inhaler technique errors. This study will deploy this product in COPD patients to establish foundational data on Digihaler metrics in a COPD population at greater risk for COPD exacerbations.

Adult subjects with COPD recruited from two sites [University of North Carolina (UNC) and Wake Forest] will participate in a longitudinal study to collect data regarding the normal variation in Digihaler metrics (PIF, inhalation volume, number of inhalations), a daily self-assessment asking "How are you feeling?" with responses provided on a Likert scale as well as responses to a Digihaler metric algorithm-triggered digital automated questionnaire (DAQ) in a stable COPD population with history of an AECOPD, to assess correlations of Digihaler metrics to daily self-assessment and DAQ responses, correlations of self-reported to actual short acting beta agonist (SABA) use and symptoms, and the changes in inhaler parameters and SABA use around incidental AECOPD.

Details
Condition Pulmonary Disease, Chronic Obstructive
Treatment Albuterol eMDPI DS
Clinical Study IdentifierNCT05241288
SponsorUniversity of North Carolina, Chapel Hill
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age >40 years old
History of cigarette smoking >=10 pack-years
Established COPD defined as physician diagnosis along with spirometry confirmation [post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC)<0.70] within the last two years and an FEV1 ≤80% predicted
Regular albuterol use (defined as at least one puff weekly for each of the last four weeks)
Currently non-hospitalized
Medical records confirmed history of two moderate AECOPD (defined as use of antibiotic or steroids to treat clinical event consistent with AECOPD) or one severe AECOPD (defined as emergency department/hospital visit) in prior 12 months
Access to smart phone, tablet or computer and internet
Willingness to switch current rescue inhaler/device to ProAir Digihaler

Exclusion Criteria

Allergy or inability/contraindication to use Albuterol Sulfate
Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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