NCT04025242

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

4.1 years

First QC Date

July 17, 2019

Last Update Submit

July 22, 2019

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

  • Actual rate of inhaler adherence

    Inhaler adherence rate assessed using a mobile electronic device

    Three months post hospitalisation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients admitted to an acute hospital with exacerbation of COPD.

You may qualify if:

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

You may not qualify if:

  • No exacerbations in previous year
  • Outpatients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 18, 2019

Study Start

February 1, 2012

Primary Completion

February 28, 2016

Study Completion

April 1, 2016

Last Updated

July 23, 2019

Record last verified: 2019-07