Impairments That Affect Correct Inhaler Use in COPD

COPD Clinical Trial

— INHALE  

Official title:

Prevalence of Impairments in Cognitive Function and Manual Dexterity in Out-patients With COPD and Associations With Correct Inhaler Techniques (INHALE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135324
• Other study ID #: 2023-INHALE
• Status: Recruiting
• Start date: December 14, 2023
• Est. completion date: July 19, 2025

Study information

• Verified date: March 2024
• Source: COPD Foundation
• Contact: Sergio Martinez
• Phone: 866-731-2673
• Email: smartinez[@]copdfoundation.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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-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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 19, 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham - Lung Health Center	Birmingham	Alabama
United States	Valley Regional Hospital	Claremont	New Hampshire
United States	United Medical Group	Miami	Florida
United States	Midwest Chest Consultants, PC	Saint Charles	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
COPD Foundation	Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence	Determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with COPD.	Through study completion, average of 1 year by assessing cognitive levels using the Mini-Mental State Exam tool and Functional Dexterity Test for impaired manual dexterity function.
Primary	Errors using inhaler devices	Assess the relationships of cognitive impairment and impaired manual dexterity with patient errors using their current pMDIs, SMIs, and/or DPIs.	Through study completion, average of 1 year using a standardized check list for assessment of Inhaler Techniques using pMDI, SMI, and/or DPIs.