A Study of Inhaler Use in the Community

Asthma Clinical Trial

Official title:

Haphazard and Careless Use of Inhalers, an Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552472
• Other study ID #: INCA-CC
• Status: Completed
• Phase: N/A
• First received: September 15, 2015
• Last updated: January 11, 2016
• Start date: August 2012
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Beaumont Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Airways Disease
• Asthma
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Ireland	Beaumont Hospital	Dublin

Sponsors (6)

Lead Sponsor	Collaborator
Beaumont Hospital	Asthma Society Ireland, GlaxoSmithKline, Health Research Board, Ireland, Irish Thoracic Society, Vitalograph Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inhaler Adherence in Time	This is adherence as measured by the INCA device in regards to time of use. This is measured as a rate of use.	One month	No
Primary	Inhaler Technique Adherence	This is adherence measured by the INCA device in regards to technique of use. This is measured as a rate.	One Month	No
Secondary	Age Measured in Years at time of recruitment	Relationship of Age to Adherence	one month	No
Secondary	Gender Measured as Male or Female	Relationship of Gender to Adherence	One Month	No
Secondary	Education Level Measured as either primary, secondary or tertiary school at recruitment.	Relationship of Education Level (Primary/Secondary/Tertiary) to Adherence	One Month	No
Secondary	Socio-economic Class Measured as the patient having either Private or Public Health Insurance	Relationship of Socio-economic class (Private or Public Health Insurance) to Adherence	One Month	No
Secondary	Health Care Use Measured as the number of visits to a General Practitioner in the previous Year	Relationship of Health Care Use (Frequency of visit to General Practitioner) to Adherence	Previous Year	No
Secondary	Hospitalisation Measured as the number of hospital admissions in the previous year	Relationship of Hospitalisation in the prevoius year to Adherence	Previous Year	No
Secondary	Exacerbation Measured as the number of Respiratory Related Exacerbations in the previous year	Relationship of Exacerbation (Respiratory related in the prevoius year) to Adherence	Previous Year	No
Secondary	Background Respiratory Diagnosis, divided into Asthma, COPD and other.	Relationship of Respiratory Diagnosis (Asthma, COPD, other) to Adherence	Previous History	No
Secondary	Smoking History measured by three categories: 1. Current Smoker, 2. Ex-Smoker and 3. Never Smoker	Relationship of Smoking History (Current, Ex-smoker, never smoker) to Adherence	Previous History	No