AsthmaNCT03899740
Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma
An observational study of Asthma, run by Association Jean Baptiste Desbrest at 1 site in France.
Trial summary
The objectives of this study are to use the Delphi method to assemble an expert panel representing innovation in asthma treatment, to collect freely suggested recommendation statements concerning OCS tapering (and sub-topics) among severe asthma patients from this panel for peer evaluation, and finally to determine… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- Brainstorming 1, Ranking - Round 1 and Ranking - Round 2
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 26 Sep 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The expert panel may include pulmonologists, endocrinologists, allergists, paediatricians and rheumatologists. Additionally, patient advocacy organization representatives will also be invited. Potential experts may respond to open invitation via the link at the end of this study registration.
Who may be able to join
- The expert is either a pulmonologist/respiratory disease specialist, an allergist, an endocrinologist, a paediatrician, a rheumatologist or a patient advocacy organisation representative
- All clinicians involved must manage patients on a weekly basis and have clinical experience in managing disease following oral corticosteroid withdrawal/tapering.
- Patient advocacy organization representatives must represent a relevant patient group (and provide contact information for their group)
Who cannot join
- Currently employed by a pharmaceutical company, or will have such employment in the upcoming 12 months
- Ownership in a pharmaceutical company or any other conflict of interest with the present study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OCS-Tapering-Delphi: Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma: A Delphi Consensus Study
The objectives of this study are to use the Delphi method to assemble an expert panel representing innovation in asthma treatment, to collect freely suggested recommendation statements concerning OCS tapering (and sub-topics) among severe asthma patients from this panel for peer evaluation, and finally to determine the level of consensus for each statement from the panel as a whole.
Read the detailed description
A series of anonymous questionnaires will be administered to a panel of experts. Each questionnaire administered results in a body of information that is re-presented to the experts before performing the next round. Initial brainstorming questionnaires are open in nature, and are used to generate statements that individual experts would like to see evaluated by their peers. Subsequent ranking questionnaires require that each expert rank each statement according to a pre-defined likert scale. Serial ranking questionnaires are administered electronically and continue until stopping rules are met, or the maximum number of allowed rounds is achieved (capped at three rounds for the present study).
Experts are recruited by invitation or response to open call (see eligibility criteria and url at the end of this declaration.)
- Conditions
- Asthma
- Being tested
- Brainstorming 1, Ranking - Round 1, Ranking - Round 2, Ranking - Round 3
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brainstorming 1Other
Expert recommendation statements will be collected for peer evaluation.
Ranking - Round 1Other
Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.
Ranking - Round 2Other
Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.
Ranking - Round 3Other
Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.
| Study group | Role | What they receive |
|---|---|---|
| The expert panel | Participation in this study will be proposed to a group of experts, including pulmonologists, endocrinologists, allergists, paediatricians and rheumatologists. Additionally, patient advocacy organization representatives will also be invited.
Experts meeting eligibility criteria (see section below) are invited to participate. Further details are available via the URL link at the end of this declaration. Receives: Other: Brainstorming 1; Other: Ranking - Round 1; Other: Ranking - Round 2; Other: Ranking - Round 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of recommendation statements achieving positive consensus
When >= 70% of the expert panel indicates either "agree" or "strongly agree" for a given statement, a positive consensus has been met.
Measured: Approximately month 5
The number of recommendation statements achieving negative consensus
When >= 70% of the expert panel indicates either "disagree" or "strongly disagree" for a given statement, a positive consensus has been met.
Measured: Approximately month 5
The number of recommendation statements achieving consensus for neutrality
When >= 70% of the expert panel indicates "neutral" for a given statement, a consensus for neutrality has been met.
Measured: Approximately month 5
Secondary outcomes (3)
The number of statements meeting the stopping rule after ranking round 1.
When >= 70% of the expert panel indicates the same score for a given statement, no subsequent rounds of ranking for that statement will be performed.
Measured: Approximately month 5
The number of statements meeting the stopping rule after ranking round 2.
When >= 70% of the expert panel indicates the same score for a given statement, no subsequent rounds of ranking for that statement will be performed.
Measured: Approximately month 5
The number of statements meeting the stopping rule after ranking round 3.
When >= 70% of the expert panel indicates the same score for a given statement, no subsequent rounds of ranking for that statement will be performed.
Measured: Approximately month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Apr 2019
- Primary completion26 Sep 2019 (estimated)
- Study completion26 Sep 2019 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Jean Baptiste Desbrest
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, University Hospital, Montpellier
- Responsible party
- Sponsor
- Investigators
- Carey Suehs, PhD, Study director, Association Jean Baptiste Desbrest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899740
- Sponsor's protocol ID
- JDB-Delphi-201903
- Status last verified
- Sep 2019
- First submitted
- 25 Mar 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be shared on an appropriate public platform at the time of publication.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCS-Tapering-Delphi: Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma: A Delphi Consensus Study
- ClinicalTrials.gov ID
- NCT03899740
- Acronym / sponsor ID
- JDB-Delphi-201903
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Association Jean Baptiste DesbrestUniversity, hospital or other
- Collaborators
- AstraZeneca, University Hospital, Montpellier
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 26 Sep 2019 (estimated)
- Study completion
- 26 Sep 2019 (estimated)
- First posted
- 2 Apr 2019 (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.
The objectives of this study are to use the Delphi method to assemble an expert panel representing innovation in asthma treatment, to collect freely suggested recommendation statements concerning OCS tapering (and sub-topics) among severe asthma patients from this panel for peer evaluation, and finally to determine the level of consensus for each statement from the panel as a whole.
Detailed description
A series of anonymous questionnaires will be administered to a panel of experts. Each questionnaire administered results in a body of information that is re-presented to the experts before performing the next round. Initial brainstorming questionnaires are open in nature, and are used to generate statements that individual experts would like to see evaluated by their peers. Subsequent ranking questionnaires require that each expert rank each statement according to a pre-defined likert scale. Serial ranking questionnaires are administered electronically and continue until stopping rules are met, or the maximum number of allowed rounds is achieved (capped at three rounds for the present study).
Experts are recruited by invitation or response to open call (see eligibility criteria and url at the end of this declaration.)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The expert panel | – | Other: Brainstorming 1, Other: Ranking - Round 1, Other: Ranking - Round 2, Other: Ranking - Round 3Participation in this study will be proposed to a group of experts, including pulmonologists, endocrinologists, allergists, paediatricians and rheumatologists. Additionally, patient advocacy organization representatives will also be invited. Experts meeting eligibility criteria (see section below) are invited to participate. Further details are available via the URL link at the end of this declaration. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The expert panel may include pulmonologists, endocrinologists, allergists, paediatricians and rheumatologists. Additionally, patient advocacy organization representatives will also be invited. Potential experts may respond to open invitation via the link at the end of this study registration.
Key inclusion criteria (3 listed)
- The expert is either a pulmonologist/respiratory disease specialist, an allergist, an endocrinologist, a paediatrician, a rheumatologist or a patient advocacy organisation representative
- All clinicians involved must manage patients on a weekly basis and have clinical experience in managing disease following oral corticosteroid withdrawal/tapering.
- Patient advocacy organization representatives must represent a relevant patient group (and provide contact information for their group)
Key exclusion criteria (2 listed)
- Currently employed by a pharmaceutical company, or will have such employment in the upcoming 12 months
- Ownership in a pharmaceutical company or any other conflict of interest with the present study
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 |
|---|---|---|
| Brainstorming 1Expert recommendation statements will be collected for peer evaluation. | Other | The expert panel |
| Ranking - Round 1Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree. | Other | The expert panel |
| Ranking - Round 2Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree. | Other | The expert panel |
| Ranking - Round 3Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree. | Other | The expert panel |
Primary outcome
The number of recommendation statements achieving positive consensus
Time frame: Approximately month 5
When >= 70% of the expert panel indicates either "agree" or "strongly agree" for a given statement, a positive consensus has been met.
The number of recommendation statements achieving negative consensus
Time frame: Approximately month 5
When >= 70% of the expert panel indicates either "disagree" or "strongly disagree" for a given statement, a positive consensus has been met.
The number of recommendation statements achieving consensus for neutrality
Time frame: Approximately month 5
When >= 70% of the expert panel indicates "neutral" for a given statement, a consensus for neutrality has been met.
3 secondary outcomes
The number of statements meeting the stopping rule after ranking round 1.
Time frame: Approximately month 5
The number of statements meeting the stopping rule after ranking round 2.
Time frame: Approximately month 5
The number of statements meeting the stopping rule after ranking round 3.
Time frame: Approximately month 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- The OCS Tapering Delphi study on the Open Science Framework.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized data will be shared on an appropriate public platform at the time of publication.
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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.
Carey Suehs, PhD study director
Association Jean Baptiste Desbrest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Association Jean Baptiste Desbrest 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Sep 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?
Results are not available in the source record.
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?
The number of recommendation statements achieving positive consensus (time frame: Approximately month 5). The study lists 3 primary outcomes in all. 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 Sep 2019.