Trials / Withdrawn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- Withdrawn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
| Type | Name | Description |
|---|---|---|
| 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 |
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.