Impairments That Affect Correct Inhaler Use in COPD

Last updated: May 7, 2025
Sponsor: COPD Foundation
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06135324
2023-INHALE
  • Ages 60-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Current diagnosis of dementia or known cognitive impairment -OR-

  2. Current diagnosis of impairment in manual dexterity including severe rheumatoidarthritis, severe arthritis/weakness of the hand/wrist, Parkinson's disease, and/orhistory of a previous cerebral vascular accident (CVA) resulting in significantmusculoskeletal deficit (in judgement of PI).

Study Design

Total Participants: 500
Study Start date:
December 14, 2023
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • University of Alabama at Birmingham - Lung Health Center

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • United Medical Group

    Miami, Florida 33135
    United States

    Site Not Available

  • RUSH University

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Lahey Clinic, Inc.

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • Midwest Chest Consultants, PC

    Saint Charles, Missouri 63301
    United States

    Site Not Available

  • Valley Regional Hospital

    Claremont, New Hampshire 03743
    United States

    Site Not Available

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Erlanger Health

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • University of Texas Medical Brach at Galveston

    Galveston, Texas 77555
    United States

    Site Not Available

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