NCT02570425

Comparing Maintenance of Device Mastery With Turbohaler© vs. Spiromax© in Healthcare Professionals naïve to Both Devices

THE HCP ELIOT STUDY: Comparing Maintenance of Device Mastery With TURBOHALER© vs. SPIROMAX© in Healthcare Professionals naïve to Both Devices (The Easy Low Instruction Over Time [ELIOT] Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 516 (actual)
• Sponsor: Research in Real-Life Ltd · Network
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This study is conducted to assess the ease of device mastery of a placebo SYMBICORT TURBOHALER vs a placebo Budesonide/Formoterol SPIROMAX device among healthcare professionals in-training (HCP).

Detailed description

The purpose of this study is to identify how intuitive devices are to use and what level of training is required to ensure that HCPs are able to demonstrate the correct technique. The two devices examined will be the SYMBICORT TURBOHALER and placebo Budesonide/Formoterol SPIROMAX device among healthcare professionals (HCP).

Conditions

• Asthma

Interventions

Type	Name	Description
DEVICE	Training on BF Spiromax followed by SYMBICORT Turbohaler	Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
DEVICE	Training on SYMBICORT Turbohaler followed by BF Spiromax	Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-09-01
• Completion: 2015-06-01
• First posted: 2015-10-07
• Last updated: 2016-05-30
• Results posted: 2016-05-30