A Study of Inhaler Use in the Community

Completed

• Conditions: Airways Disease; Asthma; Chronic Obstructive Pulmonary Disease

• Registration Number: NCT02552472
• Lead Sponsor: Beaumont Hospital

Brief Summary

This is a prospective cohort observational study of inhaler adherence in a community care setting (ie. general practice clinics and pharmacies in the community).

Detailed Description

Over a 2-4 week period, consecutive patients with a history of respiratory illness already prescribed a salmeterol/fluticasone Diskus inhaler will be asked to participate in this study. Patients will give informed consent to participate in this study of adherence, which will be assessed with the INCA device. Both clinicians and patients will be fully aware that the device is an acoustic recording device and that both time and technique of inhaler use will be assessed. Once consented, patients will be given an INCA enabled inhaler for 1 month and asked to use it as they normally would and then to return it at the end of one month. The days used and the number of doses used in the study period, as per the dose counter, will also be recorded.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2015-09-15
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-17
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Known history of Respiratory Illness
• Prescribed salmeterol/fluticasone Diskus Inhaler

Exclusion Criteria

• Unable to understand study protocol
• Refusal to sign consent form

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inhaler Technique Adherence	One Month	This is adherence measured by the INCA device in regards to technique of use. This is measured as a rate.
Inhaler Adherence in Time	One month	This is adherence as measured by the INCA device in regards to time of use. This is measured as a rate of use.

Secondary Outcome Measures

Name	Time	Method
Background Respiratory Diagnosis, divided into Asthma, COPD and other.	Previous History	Relationship of Respiratory Diagnosis (Asthma, COPD, other) to Adherence
Age Measured in Years at time of recruitment	one month	Relationship of Age to Adherence
Health Care Use Measured as the number of visits to a General Practitioner in the previous Year	Previous Year	Relationship of Health Care Use (Frequency of visit to General Practitioner) to Adherence
Exacerbation Measured as the number of Respiratory Related Exacerbations in the previous year	Previous Year	Relationship of Exacerbation (Respiratory related in the prevoius year) to Adherence
Gender Measured as Male or Female	One Month	Relationship of Gender to Adherence
Education Level Measured as either primary, secondary or tertiary school at recruitment.	One Month	Relationship of Education Level (Primary/Secondary/Tertiary) to Adherence
Hospitalisation Measured as the number of hospital admissions in the previous year	Previous Year	Relationship of Hospitalisation in the prevoius year to Adherence
Socio-economic Class Measured as the patient having either Private or Public Health Insurance	One Month	Relationship of Socio-economic class (Private or Public Health Insurance) to Adherence
Smoking History measured by three categories: 1. Current Smoker, 2. Ex-Smoker and 3. Never Smoker	Previous History	Relationship of Smoking History (Current, Ex-smoker, never smoker) to Adherence

Trial Locations

Locations (1)

Beaumont Hospital; 🇮🇪 Dublin, Ireland