Asthma
Conditions
Keywords
Asthma, inhaler device, handling
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.
Interventions
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
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Patient satisfaction questionnaire | Day 8 of each treatment | Questionnaire of satisfaction about the use of each device |
Countries
France
Outcome results
None listed