Impairments That Affect Correct Inhaler Use in COPD

NCT06135324 | Active Not Recruiting

• 1 other identifier: 2023-INHALE
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 9

Brief Summary

INHALE is a one-year, multi-site observational research study funded by Viatris, with two aims:

1. 1.Determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with chronic obstructive pulmonary disease (COPD).
2. 2.Assess the relationship of cognitive impairment and impaired manual dexterity with patient errors using current pMDIs, SMIs and/or DPIs.

Conditions

COPD

Keywords

COPD; Inhaler

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• COPD Foundation: lead
• Viatris Inc.: collaborator

Study Sites (9)

University of Alabama at Birmingham - Lung Health Center

Birmingham, Alabama, 35233, United States

Location

RUSH University

Chicago, Illinois, 60612, United States

Location

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

Location

Midwest Chest Consultants, PC

Saint Charles, Missouri, 63301, United States

Location

Valley Regional Hospital

Claremont, New Hampshire, 03743, United States

Location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Erlanger Health

Chattanooga, Tennessee, 37403, United States

Location

University of Texas Medical Brach at Galveston

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Donald A Mahler, MD

  Valley Regional Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 18, 2023
• Study Start: December 14, 2023
• Primary Completion: April 30, 2025
• Study Completion: October 31, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)