OUTER SPACE: A pilot study on inhaler treatment adherence using a smart spacer in adults with COPD
Completed
- Conditions
- COPD
- Registration Number
- NL-OMON27015
- Lead Sponsor
- Trudell medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
(1) adults >40 years; (2) spirometry confirmed COPD; (3) using formoterol (+/-ICS+/- LAMA+/- SABA) administered by pMDIs and spacer; (4) willing to sign informed consent
Exclusion Criteria
(1) < 40 years; (2) exacerbation in the last 3 months (defined as use of antibiotics and/or prednisone short-course and/or admission to a ED or hospital).
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Explore the effects of pre-post inhaler education: on the distribution of medication adherence patterns (persistence and inhaler technique, as measured by a smart spacer).
- Secondary Outcome Measures
Name Time Method Explore the effect of the pre-post inhaler education: on the drug concentration in hair, and its relation with clinical outcomes in patients with COPD.<br>Assess patient and healthcare provider satisfaction with the inhaler education<br>Inform the design of a large RCT <br>