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

Not Applicable

Withdrawn

• Conditions: Asthma
• Interventions: Device: placebo Diskus®; Device: placebo Ellipta®; Device: Pulmicort® Turbuhaler®

• Registration Number: NCT03175926
• Lead Sponsor: University Hospital, Bordeaux

Brief 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.

Study Timeline

• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-31
• Study First Posted: 2017-06-05
• Study Start: 2017-12-01
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	placebo Diskus®	placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
Group 2	Pulmicort® Turbuhaler®	placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
Group 1	Pulmicort® Turbuhaler®	placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
Group 2	placebo Ellipta®	placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
Group 1	placebo Ellipta®	placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
Group 1	placebo Diskus®	placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
Group 3	placebo Ellipta®	placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
Group 3	Pulmicort® Turbuhaler®	placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
Group 3	placebo Diskus®	placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®

Primary Outcome Measures

Name	Time	Method
Critical errors	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

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction questionnaire	Day 8 of each treatment	Questionnaire of satisfaction about the use of each device
Non device-dependent errors	Day 8 of each treatment	Assessment of the presence of non device-dependent errors from standardized checklist with first device
Time for drug administration	Day 8 of each treatment	Measure of the necessary time for drug administration with each device

Trial Locations

Locations (1)

Bordeaux University Hospital; 🇫🇷 Bordeaux, France