Objective Assessment of Adherence to Inhalers by COPD Patients

COPD Clinical Trial

Official title:

Objective Assessment of Adherence to Inhalers by COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04025242
• Other study ID #: INCA-COPD
• Status: Completed
• Start date: February 1, 2012
• Est. completion date: April 1, 2016

Study information

• Verified date: July 2019
• Source: Beaumont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: April 1, 2016
• Est. primary completion date: February 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beaumont Hospital

Outcome

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