Description of the Ability to Learn How to Handle Inhaler Devices in Asthma
NCT ID: NCT03175926
Last Updated: 2019-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-12-01
2018-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Group 1
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
placebo Diskus®
device will be given daily for one week, two puffs per day
placebo Ellipta®
device will be given daily for one week, one puff per day
Pulmicort® Turbuhaler®
device will be given daily for one week, two puffs per day
Group 2
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
placebo Diskus®
device will be given daily for one week, two puffs per day
placebo Ellipta®
device will be given daily for one week, one puff per day
Pulmicort® Turbuhaler®
device will be given daily for one week, two puffs per day
Group 3
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
placebo Diskus®
device will be given daily for one week, two puffs per day
placebo Ellipta®
device will be given daily for one week, one puff per day
Pulmicort® Turbuhaler®
device will be given daily for one week, two puffs per day
Interventions
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placebo Diskus®
device will be given daily for one week, two puffs per day
placebo Ellipta®
device will be given daily for one week, one puff per day
Pulmicort® Turbuhaler®
device will be given daily for one week, two puffs per day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Pierre Olivier GIRODET, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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Bordeaux University Hospital
Bordeaux, , France
Countries
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Other Identifiers
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CHUBX 2015/15
Identifier Type: -
Identifier Source: org_study_id
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