Description of the Ability to Learn How to Handle Inhaler Devices in Asthma

Study Overview
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Brief Summary
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Asthma is a major public health problem. The main treatments against asthma are delivered to the lung through several dry-powder inhaler such as Turbuhaler ®, Diskus® and the new Ellipta® device. In real life, patient's ability to handle a device is not routinely assessed by their practitioner. We hypothesized that many asthmatics cannot properly prepare and prime their device, which may alter the positive effects observed in clinical trials.

Detailed Description
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The main objective of this study is to describe the handling of inhaler devices (Diskus®, Turbuhaler® and Ellipta®) in patients with asthma. All participants will use each inhaler device (Diskus®, Turbuhaler® and Ellipta®) daily for one week: Two puffs per day (Diskus® and Turbuhaler®), One puff per day (Ellipta®). At each visit (day 1, 8, 15 and 22), patients will have a physical exam. For each inhaler device, 4 video recordings will be performed: Video recording #1: Inhalation (one puff) without any instruction of use. Video recording #2: Inhalation (one puff) after reading the patient information leaflet. Video recording #3: Inhalation (one puff) after watching a standardized video demonstrating correct inhaler technique. Video recording #4: inhalation (one puff) after seven days of daily use. The patient will be asked to fulfill a satisfaction survey about each inhaler device.

Official Title
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Description of the Ability to Learn How to Handle Inhaler Devices in Asthma - AUDIT

Conditions
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Asthma

Intervention / Treatment
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* Device: placebo Diskus®
* Device: placebo Ellipta®
* Device: Pulmicort® Turbuhaler®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged more than 18 years Written informed consent Diagnosis of asthma according to international guidelines (GINA 2017) Social security or health insurance Women using an effective method of birth control. Exclusion Criteria: Previous treatment with Ellipta®, Diskus® or Turbuhaler® Asthma exacerbation within 6 weeks before inclusion Subject having close contacts with devices (Ellipta®, Diskus® or Turbuhaler®) users, currently or in the past Severe asthma Hypersensitivity to budesonide Chronic psychiatric disease Medical condition that may affect handling of inhaler devices Subject deprived of his/her liberty Protected adult Subject in exclusion period related to another protocol Pregnant or breastfeeding women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler® | Device: placebo Diskus®<br>* device will be given daily for one week, two puffs per day<br>Device: placebo Ellipta®<br>* device will be given daily for one week, one puff per day<br>Device: Pulmicort® Turbuhaler®<br>* device will be given daily for one week, two puffs per day<br>|
| Experimental: Group 2<br>placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler® | Device: placebo Diskus®<br>* device will be given daily for one week, two puffs per day<br>Device: placebo Ellipta®<br>* device will be given daily for one week, one puff per day<br>Device: Pulmicort® Turbuhaler®<br>* device will be given daily for one week, two puffs per day<br>|
| Experimental: Group 3<br>placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler® | Device: placebo Diskus®<br>* device will be given daily for one week, two puffs per day<br>Device: placebo Ellipta®<br>* device will be given daily for one week, one puff per day<br>Device: Pulmicort® Turbuhaler®<br>* device will be given daily for one week, two puffs per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Critical errors | Assessment of the presence of at least a critical error in the use of the inhalation system, from standardized checklist | Day 8 of each treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non device-dependent errors | Assessment of the presence of non device-dependent errors from standardized checklist with first device | Day 8 of each treatment | 
| Time for drug administration | Measure of the necessary time for drug administration with each device | Day 8 of each treatment | 
| Patient satisfaction questionnaire | Questionnaire of satisfaction about the use of each device | Day 8 of each treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, inhaler device, handling