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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02203266
• Date of registration: 27/07/2014
• Prospective Registration: No
• Primary sponsor: Beaumont Hospital
• Public title: Teaching Inhaler Use With the INCA Device in a Community Pharmacy Setting
• Scientific title: 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
• Date of first enrolment: February 2014
• Target sample size: 152
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02203266
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Ireland

Contacts

• Name: Richard Costello, Professor
• Affiliation: Royal College of Surgeons in Ireland, Clinical Research Centre, Beaumont Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Pulmonary Disease, Chronic Obstructive

Intervention(s)

Behavioral: Education

Device: Feedback

Primary Outcome(s)

Rate of adherence [Time Frame: 2 months and 6 months]

Secondary Outcome(s)

Rescue antibiotic and/or steroid medication use [Time Frame: 6 months]

Technique adherence [Time Frame: Two months and six months]

Quality of life [Time Frame: 2 months and 6 months]

Adherence in the time domain [Time Frame: Two months and six months]

Rescue inhaled medication use [Time Frame: Six months]

Secondary ID(s)

RC004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Royal College of Surgeons, Ireland