Objective Assessment of Adherence to Inhalers by COPD Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04025242

Enrollment

244

Registered

2019-07-18

Start date

2012-02-01

Completion date

2016-04-01

Last updated

2019-07-23

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

Conditions

COPD

Brief summary

Rationale: Objective adherence to inhaled therapy by patients with chronic obstructive pulmonary disease (COPD) has not been reported. Objectives: To objectively quantify adherence to preventer Diskus inhaler therapy by patients with COPD with an electronic audio recording device (INCA). Methods: This was a prospective observational study. On discharge from hospital patients were given a salmeterol/fluticasone inhaler with an INCA device attached. Analysis of this audio quantified the frequency and proficiency of inhaler use.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients hospitalised with an exacerbation of COPD * FEV1/FVC \<70% or FEV1 \<80% * Age\>40 years * smoking history * Previously prescribed fluticasone/salmeterol inhaler

Exclusion criteria

* No exacerbations in previous year * Outpatients

Design outcomes

Primary

Measure	Time frame	Description
Actual rate of inhaler adherence	Three months post hospitalisation	Inhaler adherence rate assessed using a mobile electronic device

Outcome results