Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03175926

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

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

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
University Hospital, Bordeaux · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEplacebo Diskus®device will be given daily for one week, two puffs per day
DEVICEplacebo Ellipta®device will be given daily for one week, one puff per day
DEVICEPulmicort® Turbuhaler®device will be given daily for one week, two puffs per day

Timeline

Start date
2017-12-01
Primary completion
2018-09-01
Completion
2018-09-01
First posted
2017-06-05
Last updated
2019-02-04

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03175926. Inclusion in this directory is not an endorsement.