INHALE: Impairments That Affect Correct Inhaler Use in COPD

• Sponsor: COPD Foundation (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06135324
• Collaborator: Viatris Inc. (Industry)
• Enrollment: 500
• Anticipated Duration (Months): 19.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD

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 Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Prevalence of Impairments in Cognitive Function and Manual Dexterity in Out-patients With COPD and Associations With Correct Inhaler Techniques (INHALE)
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 19, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 90 Years
• Sexes Eligible for Study: 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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• COPD Foundation
• Viatris Inc.

Investigators

• Principal Investigator: Donald A Mahler, MD, Valley Regional Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: COPD Foundation
• ClinicalTrials.gov Identifier: NCT06135324
• Other Study ID Numbers: 2023-INHALE
• First Posted: Nov 18, 2023
• Last Update Posted: Nov 18, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by COPD Foundation: COPD; Inhaler

Study Results

No Results Posted as of Nov 18, 2023