Comparing Maintenance of Device Mastery With Turbohaler© vs. Spiromax© in Healthcare Professionals naïve to Both Devices (HCP-ELIOT)

Research in Real-Life

Status: Completed

Conditions: Asthma

Treatments: Device: Training on BF Spiromax followed by SYMBICORT Turbohaler; Device: Training on SYMBICORT Turbohaler followed by BF Spiromax

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT02570425

OR00114

Details and patient eligibility

About

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).

Full 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).

Enrollment: 516 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Written informed consent is obtained and dated by the participant before conducting any study related procedures.
• The participant is a student that is currently enrolled in the University where the study is conducted
• The participant must be willing and able to comply with study restrictions and to remain at the study site for the required duration during the study period, and willing to return to the site for the follow up evaluation as specified in this protocol.
• The participant has not previously used or received training in the use of either the SPIROMAX or the TURBOHALER in the last 6 months

Exclusion criteria

• Participants will be excluded from participating in this study if they have asthma.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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516 participants in 2 patient groups, including a placebo group

Spiromax followed by Turbohaler

Placebo Comparator group

Description:

Training on BF Spiromax followed by SYMBICORT Turbohaler

Treatment:

Device: Training on BF Spiromax followed by SYMBICORT Turbohaler

Device: Training on SYMBICORT Turbohaler followed by BF Spiromax

Turbohaler followed by Spiromax

Placebo Comparator group

Description:

Training on SYMBICORT Turbohaler followed by BF Spiromax

Treatment:

Device: Training on BF Spiromax followed by SYMBICORT Turbohaler

Device: Training on SYMBICORT Turbohaler followed by BF Spiromax