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

NCT ID: NCT03175926

Last Updated: 2019-02-04

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-09-01

Brief Summary

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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

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group 1

placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®

Group Type EXPERIMENTAL

placebo Diskus®

Intervention Type DEVICE

device will be given daily for one week, two puffs per day

placebo Ellipta®

Intervention Type DEVICE

device will be given daily for one week, one puff per day

Pulmicort® Turbuhaler®

Intervention Type DEVICE

device will be given daily for one week, two puffs per day

Group 2

placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®

Group Type EXPERIMENTAL

placebo Diskus®

Intervention Type DEVICE

device will be given daily for one week, two puffs per day

placebo Ellipta®

Intervention Type DEVICE

device will be given daily for one week, one puff per day

Pulmicort® Turbuhaler®

Intervention Type DEVICE

device will be given daily for one week, two puffs per day

Group 3

placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®

Group Type EXPERIMENTAL

placebo Diskus®

Intervention Type DEVICE

device will be given daily for one week, two puffs per day

placebo Ellipta®

Intervention Type DEVICE

device will be given daily for one week, one puff per day

Pulmicort® Turbuhaler®

Intervention Type DEVICE

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

Intervention Type DEVICE

placebo Ellipta®

device will be given daily for one week, one puff per day

Intervention Type DEVICE

Pulmicort® Turbuhaler®

device will be given daily for one week, two puffs per day

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

Other Identifiers

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CHUBX 2015/15

Identifier Type: -

Identifier Source: org_study_id

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