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

University Hospital of Bordeaux

Status: Withdrawn

Conditions: Asthma

Treatments: Device: placebo Ellipta®; Device: Pulmicort® Turbuhaler®; Device: placebo Diskus®

Study type: Interventional

Funder types: Other

Identifiers

NCT03175926

CHUBX 2015/15

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Group 1

Experimental group

Description:

placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®

Treatment:

Device: placebo Ellipta®

Device: Pulmicort® Turbuhaler®

Device: placebo Diskus®

Group 2

Experimental group

Description:

placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®

Treatment:

Device: placebo Ellipta®

Device: Pulmicort® Turbuhaler®

Device: placebo Diskus®

Group 3

Experimental group

Description:

placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®

Treatment:

Device: placebo Ellipta®

Device: Pulmicort® Turbuhaler®

Device: placebo Diskus®