A Study of Inhaler Use in the Community

NCT ID: NCT02552472

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-10-31

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.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease; Airways Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asthma Society Ireland

UNKNOWN

Sponsor Role: collaborator

Irish Thoracic Society

OTHER

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Vitalograph Ireland

UNKNOWN

Sponsor Role: collaborator

Health Research Board, Ireland

OTHER

Sponsor Role: collaborator

Beaumont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Professor Richard Costello

Professor Richard W Costello

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard W Costello, MD

Role: PRINCIPAL_INVESTIGATOR

RCSI, Beaumont Hospital

Locations

Beaumont Hospital

Dublin, Dublin, Ireland

Countries

Ireland

Other Identifiers

INCA-CC

Identifier Type: -

Identifier Source: org_study_id