Objective Assessment of Adherence to Inhalers by COPD Patients

NCT ID: NCT04025242

Last Updated: 2019-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

244 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-01

Study Completion Date

2016-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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COPD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beaumont Hospital

OTHER

Sponsor Role lead

Responsible Party

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Professor Richard Costello

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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INCA-COPD

Identifier Type: -

Identifier Source: org_study_id

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