AsthmaAUDITNCT03175926
Description of the Ability to Learn How to Handle Inhaler Devices in Asthma
A study testing Pulmicort® Turbuhaler® in people with Asthma, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Pulmicort® Turbuhaler®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Description of the Ability to Learn How to Handle Inhaler Devices in Asthma - AUDIT
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.
Read the 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
- Asthma
- Being tested
- placebo Diskus®, placebo Ellipta®, Pulmicort® Turbuhaler®
- Keywords
- Asthma, inhaler device, handling
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo Diskus®Device
device will be given daily for one week, two puffs per day
placebo Ellipta®Device
device will be given daily for one week, one puff per day
Pulmicort® Turbuhaler®Device
device will be given daily for one week, two puffs per day
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler® Receives: Device: placebo Diskus®; Device: placebo Ellipta®; Device: Pulmicort® Turbuhaler® |
| Group 2 | Experimental | placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler® Receives: Device: placebo Diskus®; Device: placebo Ellipta®; Device: Pulmicort® Turbuhaler® |
| Group 3 | Experimental | placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler® Receives: Device: placebo Diskus®; Device: placebo Ellipta®; Device: Pulmicort® Turbuhaler® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Critical errors
Assessment of the presence of at least a critical error in the use of the inhalation system, from standardized checklist
Measured: Day 8 of each treatment
Secondary outcomes (3)
Non device-dependent errors
Assessment of the presence of non device-dependent errors from standardized checklist with first device
Measured: Day 8 of each treatment
Time for drug administration
Measure of the necessary time for drug administration with each device
Measured: Day 8 of each treatment
Patient satisfaction questionnaire
Questionnaire of satisfaction about the use of each device
Measured: Day 8 of each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Sep 2018 (estimated)
Why it stopped: Refusal by the ethics committee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Olivier GIRODET, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175926
- Sponsor's protocol ID
- CHUBX 2015/15
- Acronym
- AUDIT
- Status last verified
- Feb 2019
- First submitted
- 11 May 2017
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Ability to Learn How to Handle Inhaler Devices in Asthma - AUDIT
- ClinicalTrials.gov ID
- NCT03175926
- Acronym / sponsor ID
- AUDIT / CHUBX 2015/15
- Conditions
- Asthma
- Keywords
- Asthma, inhaler device, handling
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Refusal by the ethics committee
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: placebo Diskus®, Device: placebo Ellipta®, Device: Pulmicort® Turbuhaler®placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler® |
| Group 2 | Experimental | Device: placebo Diskus®, Device: placebo Ellipta®, Device: Pulmicort® Turbuhaler®placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler® |
| Group 3 | Experimental | Device: placebo Diskus®, Device: placebo Ellipta®, Device: Pulmicort® Turbuhaler®placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo Diskus®device will be given daily for one week, two puffs per day | Device | Group 1, Group 2, Group 3 |
| placebo Ellipta®device will be given daily for one week, one puff per day | Device | Group 1, Group 2, Group 3 |
| Pulmicort® Turbuhaler®device will be given daily for one week, two puffs per day | Device | Group 1, Group 2, Group 3 |
Primary outcome
Critical errors
Time frame: 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
3 secondary outcomes
Non device-dependent errors
Time frame: Day 8 of each treatment
Time for drug administration
Time frame: Day 8 of each treatment
Patient satisfaction questionnaire
Time frame: Day 8 of each treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Olivier GIRODET, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmicort® Turbuhaler® in people with Asthma, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Critical errors (time frame: Day 8 of each treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.