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

February 1, 2019 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33600
        • Bordeaux University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 8 of each treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 8 of each treatment
Time for drug administration
Time Frame: Day 8 of each treatment
Measure of the necessary time for drug administration with each device
Day 8 of each treatment
Patient satisfaction questionnaire
Time Frame: Day 8 of each treatment
Questionnaire of satisfaction about the use of each device
Day 8 of each treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Pierre Olivier GIRODET, MD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2017

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 31, 2017

First Posted (Actual)

June 5, 2017

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2015/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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