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OpenTrials
Completed

NCT Number: NCT04025242

Objective Assessment of Adherence to Inhalers by COPD Patients

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Actual rate of inhaler adherence

    Time frame: Three months post hospitalisation

    Inhaler adherence rate assessed using a mobile electronic device

Sponsors and collaborators

Lead sponsor

Beaumont Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 18, 2019
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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