Pulmonary Disease, Chronic ObstructiveNCT05241288
Digihaler in Chronic Obstructive Pulmonary Disease (COPD)
A study testing Albuterol eMDPI DS in people with Pulmonary Disease, Chronic Obstructive, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Albuterol eMDPI DS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2022to 13 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Use of ProAir Digihaler in Chronic Obstructive Pulmonary Disease (COPD) - Characterization of Inhalation Metrics From a Cohort of Patient At-risk for Acute Exacerbation of COPD (AECOPD) in an Outpatient Setting
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.
Read the detailed 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Albuterol eMDPI DS
- Keywords
- Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases, Albuterol, Bronchodilator Agents, Respiratory System Agents
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuterol eMDPI DSCombination product
Also called ProAir® Digihaler®
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)
| Study group | Role | What they receive |
|---|---|---|
| Albuterol eMDPI DS (ProAir® Digihaler®) | Experimental | This arm will receive the intervention of the Albuterol eMDPI DS for three months. Receives: Combination Product: Albuterol eMDPI DS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Variability in Peak Inspiratory Flow (PIF)
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.
Measured: 3 months
Variability in Peak Inspiratory Flow (PIF) as Measured by Coefficient of Variation
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.
Measured: 3 months
Secondary outcomes (3)
Correlation of Self-Reported Inhaler Use With Actual Inhaler Use
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.
Measured: 3 months
Mean Variability in Inhalation Volume
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.
Measured: 3 months
Variability in Inhalation Volume as Measured by Coefficient of Variation
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 Mar 2022
- Primary completion13 Feb 2023
- Study completion13 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the intervention consisting of Albuterol eMDPI DS (ProAir® Digihaler®). Participants will be asked to use the ProAir Digihaler as their primary mode of SABA therapy as they would in usual treatment and indicated in the product package insert and Instructions for Use. They will answer a daily self-assessment on the DAQ App, as well as Digihaler metric algorithm-triggered DAQ on the DAQ app. The DAQ will collect yes/no responses to questions focused on change in symptoms. The participants will be contacted once per month to collect COPD Assessment Test (CAT) score and self-reported average albuterol use over the preceding month. They will also be asked about any AECOPD events requiring treatment.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences, Teva Branded Pharmaceutical Products R&D, Inc.
- Responsible party
- Sponsor
- Investigators
- Michael B Drummond, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241288
- Sponsor's protocol ID
- 21-0273
- Status last verified
- Apr 2023
- First submitted
- 4 Feb 2022
- Last updated
- 23 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of ProAir Digihaler in Chronic Obstructive Pulmonary Disease (COPD) - Characterization of Inhalation Metrics From a Cohort of Patient At-risk for Acute Exacerbation of COPD (AECOPD) in an Outpatient Setting
- ClinicalTrials.gov ID
- NCT05241288
- Acronym / sponsor ID
- 21-0273
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases, Albuterol, Bronchodilator Agents, Respiratory System Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences, Teva Branded Pharmaceutical Products R&D, Inc.
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 13 Feb 2023 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Posted 23 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the intervention consisting of Albuterol eMDPI DS (ProAir® Digihaler®). Participants will be asked to use the ProAir Digihaler as their primary mode of SABA therapy as they would in usual treatment and indicated in the product package insert and Instructions for Use. They will answer a daily self-assessment on the DAQ App, as well as Digihaler metric algorithm-triggered DAQ on the DAQ app. The DAQ will collect yes/no responses to questions focused on change in symptoms. The participants will be contacted once per month to collect COPD Assessment Test (CAT) score and self-reported average albuterol use over the preceding month. They will also be asked about any AECOPD events requiring treatment.
| Arm | Type | Receives |
|---|---|---|
| Albuterol eMDPI DS (ProAir® Digihaler®) | Experimental | Combination Product: Albuterol eMDPI DSThis arm will receive the intervention of the Albuterol eMDPI DS for three months. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albuterol eMDPI DSAlso: ProAir® Digihaler®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) | Combination product | Albuterol eMDPI DS (ProAir® Digihaler®) |
Primary outcome
Mean Variability in Peak Inspiratory Flow (PIF)
Time frame: 3 months
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.
Variability in Peak Inspiratory Flow (PIF) as Measured by Coefficient of Variation
Time frame: 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.
3 secondary outcomes
Correlation of Self-Reported Inhaler Use With Actual Inhaler Use
Time frame: 3 months
Mean Variability in Inhalation Volume
Time frame: 3 months
Variability in Inhalation Volume as Measured by Coefficient of Variation
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Drummond, MD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albuterol eMDPI DS in people with Pulmonary Disease, Chronic Obstructive, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Variability in Peak Inspiratory Flow (PIF) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.