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

Primary Purpose

Asthma

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
placebo Diskus®
placebo Ellipta®
Pulmicort® Turbuhaler®
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring Asthma, inhaler device, handling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bordeaux University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®

placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®

placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®

Outcomes

Primary Outcome Measures

Critical errors
Assessment of the presence of at least a critical error in the use of the inhalation system, from standardized checklist

Secondary Outcome Measures

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

Full Information

First Posted
May 11, 2017
Last Updated
February 1, 2019
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03175926
Brief Title
Description of the Ability to Learn How to Handle Inhaler Devices in Asthma
Acronym
AUDIT
Official Title
Description of the Ability to Learn How to Handle Inhaler Devices in Asthma - AUDIT
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Refusal by the ethics committee
Study Start Date
December 1, 2017 (Anticipated)
Primary Completion Date
September 1, 2018 (Anticipated)
Study Completion Date
September 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, inhaler device, handling

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
Arm Title
Group 2
Arm Type
Experimental
Arm Description
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
Arm Title
Group 3
Arm Type
Experimental
Arm Description
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
Intervention Type
Device
Intervention Name(s)
placebo Diskus®
Intervention Description
device will be given daily for one week, two puffs per day
Intervention Type
Device
Intervention Name(s)
placebo Ellipta®
Intervention Description
device will be given daily for one week, one puff per day
Intervention Type
Device
Intervention Name(s)
Pulmicort® Turbuhaler®
Intervention Description
device will be given daily for one week, two puffs per day
Primary Outcome Measure Information:
Title
Critical errors
Description
Assessment of the presence of at least a critical error in the use of the inhalation system, from standardized checklist
Time Frame
Day 8 of each treatment
Secondary Outcome Measure Information:
Title
Non device-dependent errors
Description
Assessment of the presence of non device-dependent errors from standardized checklist with first device
Time Frame
Day 8 of each treatment
Title
Time for drug administration
Description
Measure of the necessary time for drug administration with each device
Time Frame
Day 8 of each treatment
Title
Patient satisfaction questionnaire
Description
Questionnaire of satisfaction about the use of each device
Time Frame
Day 8 of each treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Olivier GIRODET, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bordeaux University Hospital
City
Bordeaux
ZIP/Postal Code
33600
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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