- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Actual rate of inhaler adherence
Time Frame: Three months post hospitalisation
|
Inhaler adherence rate assessed using a mobile electronic device
|
Three months post hospitalisation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- INCA-COPD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COPD
-
University Medical Center GroningenCompleted
-
Peking University First HospitalFirst Affiliated Hospital Xi'an Jiaotong University; Shandong Provincial Hospital and other collaboratorsRecruiting
-
Hôpital NOVORecruiting
-
Rigshospitalet, DenmarkRecruiting
-
NHS Greater Glasgow and ClydeLenus Health; University of Glasgow Robertson Centre for Bio StatisticsRecruiting
-
Xemed LLCUniversity of Pennsylvania; Temple UniversityNot yet recruiting
-
Erasme University HospitalRecruiting
-
Istituti Clinici Scientifici Maugeri SpARecruiting
-
Temple UniversityGlaxoSmithKlineNot yet recruiting