Status:
ACTIVE_NOT_RECRUITING
Impairments That Affect Correct Inhaler Use in COPD
Lead Sponsor:
COPD Foundation
Collaborating Sponsors:
Viatris Inc.
Conditions:
COPD
Eligibility:
All Genders
60-90 years
Brief Summary
INHALE is a one-year, multi-site observational research study funded by Viatris, with two aims: 1. Determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-pa...
Detailed Description
To prescribe inhaled therapy for patients with COPD, health care professionals (HCPs) must make three decisions: short vs long-acting medication, medication class (beta2 agonists, muscarinic antagonis...
Eligibility Criteria
Inclusion
- Age \> 60 years
- \> 10 pack-years smoking cigarettes
- Diagnosis of COPD based on GOLD Criteria
- Pulmonary function tests showing FEV1 \< 60% predicted (pre-BD).
- Current use of one or more hand-held inhalers (pMDIs, SMIs, and/or DPIs).
Exclusion
- Current diagnosis of dementia or known cognitive impairment -OR-
- Current diagnosis of impairment in manual dexterity including severe rheumatoid arthritis, severe arthritis/weakness of the hand/wrist, Parkinson's disease, and/or history of a previous cerebral vascular accident (CVA) resulting in significant musculoskeletal deficit (in judgement of PI).
Key Trial Info
Start Date :
December 14 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06135324
Start Date
December 14 2023
End Date
October 31 2025
Last Update
May 11 2025
Active Locations (9)
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1
University of Alabama at Birmingham - Lung Health Center
Birmingham, Alabama, United States, 35233
2
RUSH University
Chicago, Illinois, United States, 60612
3
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
4
Midwest Chest Consultants, PC
Saint Charles, Missouri, United States, 63301