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Active, Not Recruiting

NCT Number: NCT06135324

Impairments That Affect Correct Inhaler Use in COPD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham - Lung Health Center, Birmingham, Alabama, United States

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About this study

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:

  • Cognitive impairment (mild to severe) is present in > 20% of this COPD population
  • Impaired manual dexterity (minimally functional to nonfunctional) is present in > 20% of this COPD population
  • Both cognitive impairment and impaired manual dexterity are associated with patient errors using their current hand-held inhalers.

The objectives of this study are:

  • To determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with COPD
  • To assess the relationships of cognitive impairment and impaired manual dexterity with patient errors using their current pMDIs, SMIs, and/or DPIs.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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).

Treatment and study plan

Primary outcomes

  1. Prevalence

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

COPD Foundation

Other

Collaborators

  • Viatris Inc.

Registry information

Official study title

Prevalence of Impairments in Cognitive Function and Manual Dexterity in Out-patients With COPD and Associations With Correct Inhaler Techniques (INHALE)

Acronym: INHALE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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