OUTER SPACE: A pilot study on inhaler treatment adherence using a smart spacer in adults with COPD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27015

Enrollment

Registered

2020-11-05

Start date

2021-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

COPD

Interventions

Data of the smart spacer will be used to customize the inhalation education COPD patients receive

Eligibility

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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. Assess patient and healthcare provider satisfaction with the inhaler education Inform the design of a large RCT	—

Contacts

Public ContactJob van Boven

UMCG / MAECON

j.f.m.van.boven@umcg.nl+31 (50) 361 78 93

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)