Impairments That Affect Correct Inhaler Use in COPD (INHALE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: 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 Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham - Lung Health Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic, Inc.
  • Missouri
    • Saint Charles, Missouri, United States, 63301
      • Midwest Chest Consultants, PC
  • New Hampshire
    • Claremont, New Hampshire, United States, 03743
      • Valley Regional Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Health
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Brach at Galveston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

As this is a novel proposal, there are no data to calculate a sample size. If 20% of patients exhibit cognitive impairment and 20% exhibit impairment in manual dexterity, 500 total patients provide a sample size of at least 100 patients to examine the relationships between these impairments and errors in correct inhaler use. To ensure an adequate number of patients with an impairment, the study team will receive weekly reports containing a summary of proportion of patients exhibiting either cognitive impairment or impairment in manual dexterity and may stop recruitment once at least 100 patients with an impairment and 100 patients with no impairment have been enrolled. A maximum of 500 patients will be enrolled.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: COPD Foundation
• Collaborators: Viatris Inc.
• Investigators: Principal Investigator: Donald A Mahler, MD, Valley Regional Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2023
• Primary Completion (Actual): April 30, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Inhaler
• Other Study ID Numbers: 2023-INHALE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No