Impairments That Affect Correct Inhaler Use in COPD

Active, not recruiting

• Conditions: COPD

• Registration Number: NCT06135324
• Lead Sponsor: COPD Foundation

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-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.

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.

Study Timeline

• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-18
• Study Start: 2023-12-14
• Primary Completion: 2025-04-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Errors using inhaler devices	Through study completion, average of 1 year using a standardized check list for assessment of Inhaler Techniques using pMDI, SMI, and/or DPIs.	Assess the relationships of cognitive impairment and impaired manual dexterity with patient errors using their current pMDIs, SMIs, and/or DPIs.
Prevalence	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.	Determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with COPD.

Trial Locations

Locations (9)

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