Skip to main content
OpenTrials
Completed

NCT Number: NCT02552472

A Study of Inhaler Use in the Community

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Airways Disease Bronchial Diseases Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beaumont Hospital

Dublin, D9, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Inhaler Adherence in Time

    Time frame: 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.

  2. Inhaler Technique Adherence

    Time frame: One Month

    This is adherence measured by the INCA device in regards to technique of use. This is measured as a rate.

Secondary outcomes

  1. Age Measured in Years at time of recruitment

    Time frame: one month

    Relationship of Age to Adherence

  2. Gender Measured as Male or Female

    Time frame: One Month

    Relationship of Gender to Adherence

  3. Education Level Measured as either primary, secondary or tertiary school at recruitment.

    Time frame: One Month

    Relationship of Education Level (Primary/Secondary/Tertiary) to Adherence

  4. Socio-economic Class Measured as the patient having either Private or Public Health Insurance

    Time frame: One Month

    Relationship of Socio-economic class (Private or Public Health Insurance) to Adherence

  5. Health Care Use Measured as the number of visits to a General Practitioner in the previous Year

    Time frame: Previous Year

    Relationship of Health Care Use (Frequency of visit to General Practitioner) to Adherence

  6. Hospitalisation Measured as the number of hospital admissions in the previous year

    Time frame: Previous Year

    Relationship of Hospitalisation in the prevoius year to Adherence

  7. Exacerbation Measured as the number of Respiratory Related Exacerbations in the previous year

    Time frame: Previous Year

    Relationship of Exacerbation (Respiratory related in the prevoius year) to Adherence

  8. Background Respiratory Diagnosis, divided into Asthma, COPD and other.

    Time frame: Previous History

    Relationship of Respiratory Diagnosis (Asthma, COPD, other) to Adherence

  9. Smoking History measured by three categories: 1. Current Smoker, 2. Ex-Smoker and 3. Never Smoker

    Time frame: Previous History

    Relationship of Smoking History (Current, Ex-smoker, never smoker) to Adherence

Sponsors and collaborators

Lead sponsor

Beaumont Hospital

Other

Collaborators

  • Asthma Society Ireland
  • GlaxoSmithKline
  • Health Research Board, Ireland
  • Irish Thoracic Society
  • Vitalograph Ireland

Registry information

Official study title

Haphazard and Careless Use of Inhalers, an Observational Study

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 17, 2015
Registry last updated
Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.