Status:
COMPLETED
ProAir Digihaler in COPD Disease Management: A Real World Study
Lead Sponsor:
Pulmonary Research Institute of Southeast Michigan
Collaborating Sponsors:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
COPD
COPD Exacerbation Acute
Eligibility:
All Genders
45+ years
Brief Summary
A pilot study to explore the utilization of the TEVA ProAir Digihaler rescue medication use and inhalation parameters to identify disease deterioration to help in the management of COPD patients in cl...
Detailed Description
The trial is an unblinded open label single center study designed to identify trends in Peak Inspiratory Flow (PIF) rates and Rescue Albuterol Inhaler usage (Inhalations) that associate with disease d...
Eligibility Criteria
Inclusion
- Documented history of COPD by ATS/GOLD criteria
- Age \> 45 years
- Patient willing and able to:
- participate in the study, including all scheduled visits
- demonstrate the ability to use the ProAir Digihaler, including transfer of Digihaler data via blue-tooth to a smart device
- perform all required testing, including spirometry and walk tests
- complete all home questionnaires and participate in all telephone contacts
- switch current rescue inhaler/device to ProAir Digihaler
- Baseline spirometry consistent with COPD (post bronchodilator FEV1 \< 80% predicted, FEV1/FVC \<70%)
- Use of albuterol inhaler as primary device for administration of rescue therapy
- Reported use of rescue inhaler at least twice (4 inhalations) a week in the previous 6 months
- Access to smartphone with blue-tooth and cellular/internet access
Exclusion
- Allergy, contraindication or inability to use albuterol sulfate
- Frequent use of a nebulizer as rescue therapy (\>1 time per day)
- Current diagnosis of asthma
- Unstable medical condition that could prevent the completion of the research trial
- Pregnancy, planning to become pregnant or breast feeding
- Failure to use rescue inhaler during Run-in period (minimum of at least 8 rescue inhaler inhalations over the 2 weeks)
- Exacerbations that require discontinuation from study (during run-in period)
Key Trial Info
Start Date :
May 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 21 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04821869
Start Date
May 10 2021
End Date
June 21 2022
Last Update
June 13 2025
Active Locations (1)
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1
Pulmonary Research Institute of Southeast Michigan
Farmington Hills, Michigan, United States, 48336