Study evaluating ease of use, preference and satisfaction of two different Fluticason/salmeterol inhalers in asthma or COPD patients

Study evaluating ease of use, preference and satisfaction of two different Fluticason/salmeterol inhalers in asthma or COPD patients - Ease of use of two inhalers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35747

Enrollment

110

Registered

2011-11-17

Start date

2011-12-21

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma COPD

Interventions

Patients will be asked to demonstrate their proficiency with two different inhalers, after reading the package insert, and, if errors are observed, after up to three instructions.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age > 40 with stable COPD or asthma 2. Patients naïve to the study inhalers, Accuhaler/Diskus and Elpenhaler for at least 1 year 3. Patients agreeing on participating and signing the Informed Consent Form

Exclusion criteria

Exclusion criteria: 1. Patients currently participating in another randomised clinical trial 2. Patients with body malformations or diseases affecting coordination and/or motor system 3. Patients unable to read product package instructions and answer patient reported questionnaires

Design outcomes

Primary

Measure	Time frame
The percentage of COPD and asthma patients correctly (all critical items correct) using the Accuhaler/Diskus vs Elpenhaler inhaler devices after reading the package insert	—

Secondary

Measure	Time frame
To assess patients overall satisfaction with each device. To assess the number of instructions needed for correct use of each device To assess the patients overall preference for a device	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)