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Teaching Inhaler Use With the INCA Device in a Community Pharmacy Setting

A Randomised, Parallel-group, Multi-centre Trial Using a Novel INCA Tracker Device to Measure and Monitor Compliance and Technique of Seretide Diskus Inhaler in a Community Pharmacy Setting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02203266
Enrollment
152
Registered
2014-07-29
Start date
2014-02-28
Completion date
2017-01-31
Last updated
2019-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Pulmonary Disease, Chronic Obstructive

Keywords

Medication Adherence, Patient Compliance

Brief summary

The purpose of this trial is to discover whether providing feedback to patients from a device that records when and how well a patient uses a Seretide Diskus inhaler will lead to: * Improved compliance with prescribed inhaler use * Improved technique of inhaler use * A reduction in respiratory health related outcomes caused by poor inhaler compliance and usage. * An improvement in patient quality of life scores

Interventions

DEVICEFeedback

Feedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months.

BEHAVIORALEducation

Feedback on the patient's own inhaler technique as observed by pharmacist and education to support best use will be provided to patients in the demonstration group after 1,2 and 6 months.

Sponsors

Royal College of Surgeons, Ireland
CollaboratorOTHER
Beaumont Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Must be 18 years old or above * Capable of understanding and willing to provide voluntary informed consent before any protocol specific procedures are performed * Capable of understanding and complying with the requirements of the protocol, and demonstrating a willingness to attend for all required visits. * Able and willing to take inhaled medication. * Have a valid prescription for use of a Seretide diskus inhaler or already using a Seretide diskus inhaler. * Have a history of regular attendance in the pharmacy in which they are recruited which will be demonstrated by the subject having collected three prescriptions for any medication in that pharmacy in the six months preceeding their recruitment to the study.

Exclusion criteria

* Patient expressly reports that their physician has indicated that they will not be continuing to receive Seretide over the next 6 months

Design outcomes

Primary

MeasureTime frameDescription
Rate of adherence2 months and 6 monthsThe rate of adherence is the proportion of correctly taken drugs at the correct time relative to the prescribed interval.

Secondary

MeasureTime frame
Rescue inhaled medication useSix months
Rescue antibiotic and/or steroid medication use6 months
Quality of life2 months and 6 months
Adherence in the time domainTwo months and six months
Technique adherenceTwo months and six months

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026