Clinical trial NCT03175926: Description of the Ability to Learn How to Handle Inhaler Devices in Asthma
Official title: Description of the Ability to Learn How to Handle Inhaler Devices in Asthma - AUDIT
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Asthma
Keywords: Asthma
inhaler device
handling
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Critical errors
timeFrame: Day 8 of each treatment
Secondary outcomes:
measure: Non device-dependent errors
timeFrame: Day 8 of each treatment
measure: Time for drug administration
timeFrame: Day 8 of each treatment
measure: Patient satisfaction questionnaire
timeFrame: Day 8 of each treatment
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Pierre Olivier GIRODET, MD
role: PRINCIPAL_INVESTIGATOR
References: