NCT06135324

Impairments That Affect Correct Inhaler Use in COPD

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: COPD Foundation · Academic / Other
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• COPD

Timeline

• Start date: 2023-12-14
• Primary completion: 2025-04-30
• Completion: 2025-10-31
• First posted: 2023-11-18
• Last updated: 2025-05-11

Locations

9 sites across 1 country: United States