Clinical trial NCT02552472: A Study of Inhaler Use in the Community
Official title: Haphazard and Careless Use of Inhalers, an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Airways Disease
Keywords: Asthma
Inhaler Use
Adherence
Chronic Obstructive Pulmonary Disease
Lead sponsor: Beaumont Hospital
Sponsor class: OTHER
Collaborators: name: Asthma Society Ireland
name: Irish Thoracic Society
name: GlaxoSmithKline
name: Vitalograph Ireland
name: Health Research Board, Ireland
First posted: 2015-09-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be a random sample of patients with a known history of respiratory illness and already prescribed a salmeterol/fluticosone Diskus inhaler. Patients will be identified in both community pharmacy centres and general practice clinics within Ireland.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Inhaler Adherence in Time
timeFrame: One month
measure: Inhaler Technique Adherence
timeFrame: One Month
Secondary outcomes:
measure: Age Measured in Years at time of recruitment
timeFrame: one month
measure: Gender Measured as Male or Female
timeFrame: One Month
measure: Education Level Measured as either primary, secondary or tertiary school at recruitment.
timeFrame: One Month
measure: Socio-economic Class Measured as the patient having either Private or Public Health Insurance
timeFrame: One Month
measure: Health Care Use Measured as the number of visits to a General Practitioner in the previous Year
timeFrame: Previous Year
measure: Hospitalisation Measured as the number of hospital admissions in the previous year
timeFrame: Previous Year
measure: Exacerbation Measured as the number of Respiratory Related Exacerbations in the previous year
timeFrame: Previous Year
measure: Background Respiratory Diagnosis, divided into Asthma, COPD and other.
timeFrame: Previous History
measure: Smoking History measured by three categories: 1. Current Smoker, 2. Ex-Smoker and 3. Never Smoker
timeFrame: Previous History
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: RCSI, Beaumont Hospital
name: Richard W Costello, MD
role: PRINCIPAL_INVESTIGATOR
References: