Study Stopped
Refusal by the ethics committee
Description of the Ability to Learn How to Handle Inhaler Devices in Asthma
AUDIT
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2017
Shorter than P25 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2017
CompletedFirst Posted
Study publicly available on registry
June 5, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedFebruary 4, 2019
February 1, 2019
9 months
May 11, 2017
February 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Non device-dependent errors
Day 8 of each treatment
Time for drug administration
Day 8 of each treatment
Patient satisfaction questionnaire
Day 8 of each treatment
Study Arms (3)
Group 1
EXPERIMENTALplacebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
Group 2
EXPERIMENTALplacebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
Group 3
EXPERIMENTALplacebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
Interventions
device will be given daily for one week, two puffs per day
device will be given daily for one week, one puff per day
device will be given daily for one week, two puffs per day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Previous treatment with Ellipta®, Diskus® or Turbuhaler®
- 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
- Pregnant or breastfeeding women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bordeaux University Hospital
Bordeaux, 33600, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Olivier GIRODET, MD
University Hospital, Bordeaux
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2017
First Posted
June 5, 2017
Study Start
December 1, 2017
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
February 4, 2019
Record last verified: 2019-02