Loading clinical trials...
Loading clinical trials...
Prevalence of Impairments in Cognitive Function and Manual Dexterity in Out-patients With COPD and Associations With Correct Inhaler Techniques (INHALE)
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-patients with chronic obstructive pulmonary disease (COPD). 2. Assess the relationship of cognitive impairment and impaired manual dexterity with patient errors using current pMDIs, SMIs and/or DPIs.
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 antagonists and/or corticosteroids) and delivery system. At present, there is no guidance by national and international groups of experts on selecting the most appropriate delivery system for patients with COPD. On the other hand, there is a general belief among HCPs that there is no difference in efficacy among pressurized metered dose inhalers (pMDIs), slow mist inhalers (SMIs), dry powder inhalers (DPIs), and nebulizer delivery if the patient uses correct inhaler technique. Unfortunately, there is extensive evidence that patients with COPD exhibit numerous errors using hand-held devices. Experts have opined that HCPs should consider prescribing nebulizer medications for patients with COPD based on various factors or conditions, particularly cognitive impairment and problems with manual dexterity. However, there is little if any supportive evidence for these recommendations. In stable out-patients with an established diagnosis of moderate to very severe COPD (pulmonary function tests within the last 12 months that demonstrate FEV1 \< 60% Predicted required for screening purposes), we hypothesize the following: 1. Cognitive impairment (mild to severe) is present in \> 20% of this COPD population 2. Impaired manual dexterity (minimally functional to nonfunctional) is present in \> 20% of this COPD population 3. Both cognitive impairment and impaired manual dexterity are associated with patient errors using their current hand-held inhalers. The objectives of this study are: 1. To determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with COPD 2. To assess the relationships of cognitive impairment and impaired manual dexterity with patient errors using their current pMDIs, SMIs, and/or DPIs.
Age
60 - 90 years
Sex
ALL
Healthy Volunteers
Yes
University of Alabama at Birmingham - Lung Health Center
Birmingham, Alabama, United States
RUSH University
Chicago, Illinois, United States
Lahey Clinic, Inc.
Burlington, Massachusetts, United States
Midwest Chest Consultants, PC
Saint Charles, Missouri, United States
Valley Regional Hospital
Claremont, New Hampshire, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Erlanger Health
Chattanooga, Tennessee, United States
University of Texas Medical Brach at Galveston
Galveston, Texas, United States
Start Date
December 14, 2023
Primary Completion Date
April 30, 2025
Completion Date
October 31, 2025
Last Updated
May 11, 2025
500
ACTUAL participants
Lead Sponsor
COPD Foundation
Collaborators
NCT07477600
NCT07462221
NCT07351929
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions