Purpose

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.

Condition

Eligibility

Eligible Ages
Between 60 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Age > 60 years 2. > 10 pack-years smoking cigarettes 3. Diagnosis of COPD based on GOLD Criteria 4. Pulmonary function tests showing FEV1 < 60% predicted (pre-BD). 5. Current use of one or more hand-held inhalers (pMDIs, SMIs, and/or DPIs).

Exclusion Criteria

  1. Current diagnosis of dementia or known cognitive impairment -OR- 2. 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).

Study Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Prevalence of Cognitive impairment and impaired manual dexterity Determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with COPD
Assess relationship of impairments with patient errors using pMDI, SMI, and/or DPIs assess the relationships of cognitive impairment and impaired manual dexterity with patient errors using their prescribed, current pMDIs, SMIs, and/or DPIs.

Recruiting Locations

University of Texas Medical Brach at Galveston
Galveston, Texas 77555
Contact:
Kristi Craig
klcraig@utmb.edu

More Details

Status
Recruiting
Sponsor
COPD Foundation

Study Contact

Sergio Martinez
866-731-2673
smartinez@copdfoundation.org

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 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.