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

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ClinicalTrials.gov Identifier: NCT03175926
Recruitment Status : Not yet recruiting
First Posted : June 5, 2017
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Asthma Device: placebo Diskus® Device: placebo Ellipta® Device: Pulmicort® Turbuhaler® Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Description of the Ability to Learn How to Handle Inhaler Devices in Asthma - AUDIT
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : March 1, 2018
Estimated Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Group 1
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
Device: placebo Diskus®
device will be given daily for one week, two puffs per day

Device: placebo Ellipta®
device will be given daily for one week, one puff per day

Device: Pulmicort® Turbuhaler®
device will be given daily for one week, two puffs per day

Experimental: Group 2
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
Device: placebo Diskus®
device will be given daily for one week, two puffs per day

Device: placebo Ellipta®
device will be given daily for one week, one puff per day

Device: Pulmicort® Turbuhaler®
device will be given daily for one week, two puffs per day

Experimental: Group 3
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
Device: placebo Diskus®
device will be given daily for one week, two puffs per day

Device: placebo Ellipta®
device will be given daily for one week, one puff per day

Device: Pulmicort® Turbuhaler®
device will be given daily for one week, two puffs per day




Primary Outcome Measures :
  1. Critical errors [ Time Frame: Day 8 of each treatment ]
    Assessment of the presence of at least a critical error in the use of the inhalation system, from standardized checklist


Secondary Outcome Measures :
  1. Non device-dependent errors [ Time Frame: Day 8 of each treatment ]
    Assessment of the presence of non device-dependent errors from standardized checklist with first device

  2. Time for drug administration [ Time Frame: Day 8 of each treatment ]
    Measure of the necessary time for drug administration with each device

  3. Patient satisfaction questionnaire [ Time Frame: Day 8 of each treatment ]
    Questionnaire of satisfaction about the use of each device



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175926


Contacts
Contact: Pierre Olivier GIRODET, MD +33 (0)5 57 62 31 94 pierre-olivier.girodet@chu-bordeaux.fr

Locations
France
Bordeaux University Hospital Not yet recruiting
Bordeaux, France, 33600
Contact: Pierre Olivier GIRODET, MD    +33 (0)5 57 62 31 94    pierre-olivier.girodet@chu-bordeaux.fr   
Contact: Virginie NIEL    +33 (0)5 57 62 31 94    virginie.niel@chu-bordeaux.fr   
Principal Investigator: Pierre Olivier GIRODET, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Pierre Olivier GIRODET, MD University Hospital, Bordeaux

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03175926     History of Changes
Other Study ID Numbers: CHUBX 2015/15
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
Asthma
inhaler device
handling

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Lung Diseases
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists