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

Asthma Clinical Trial

— AUDIT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03175926
• Other study ID #: CHUBX 2015/15
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: February 2019
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• placebo Diskus®
device will be given daily for one week, two puffs per day
• placebo Ellipta®
device will be given daily for one week, one puff per day
• Pulmicort® Turbuhaler®
device will be given daily for one week, two puffs per day

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Critical errors	Assessment of the presence of at least a critical error in the use of the inhalation system, from standardized checklist	Day 8 of each treatment
Secondary	Non device-dependent errors	Assessment of the presence of non device-dependent errors from standardized checklist with first device	Day 8 of each treatment
Secondary	Time for drug administration	Measure of the necessary time for drug administration with each device	Day 8 of each treatment
Secondary	Patient satisfaction questionnaire	Questionnaire of satisfaction about the use of each device	Day 8 of each treatment