Clinical trial NCT06135324: Impairments That Affect Correct Inhaler Use in COPD
Official title: Prevalence of Impairments in Cognitive Function and Manual Dexterity in Out-patients With COPD and Associations With Correct Inhaler Techniques (INHALE)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COPD
Keywords: COPD
Inhaler
Lead sponsor: COPD Foundation
Sponsor class: OTHER
Collaborators: name: Viatris Inc.
First posted: 2023-11-18
Enrollment: 500
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Prevalence
timeFrame: 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.
measure: Errors using inhaler devices
timeFrame: Through study completion, average of 1 year using a standardized check list for assessment of Inhaler Techniques using pMDI, SMI, and/or DPIs.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - Lung Health Center
state: Alabama
city: Chicago
country: United States
facility: RUSH University
state: Illinois
city: Burlington
country: United States
facility: Lahey Clinic, Inc.
state: Massachusetts
city: Saint Charles
country: United States
facility: Midwest Chest Consultants, PC
state: Missouri
city: Claremont
country: United States
facility: Valley Regional Hospital
state: New Hampshire
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Chattanooga
country: United States
facility: Erlanger Health
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Brach at Galveston
state: Texas
Study officials:
affiliation: Valley Regional Hospital
name: Donald A Mahler, MD
role: PRINCIPAL_INVESTIGATOR
References: