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Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma

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ClinicalTrials.gov Identifier: NCT03899740
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Association Jean Baptiste Desbrest

Brief 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 the level of consensus for each statement from the panel as a whole.

Condition or disease Intervention/treatment
Asthma Other: Brainstorming 1 Other: Brainstorming 2 Other: Ranking - Round 1 Other: Ranking - Round 2 Other: Ranking - Round 3

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 performed live at a web conference 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.)


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: OCS-Tapering-Delphi: Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma: A Delphi Consensus Study
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
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.

Other: Brainstorming 1
Expert recommendation statements will be collected for peer evaluation.

Other: Brainstorming 2
Additional expert recommendation statements will be collected for peer evaluation.

Other: Ranking - Round 1
Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.

Other: Ranking - Round 2
Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.

Other: Ranking - Round 3
Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. The number of statements meeting the stopping rule after ranking round 1. [ Time Frame: Approximately month 5 ]
    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.

  2. The number of statements meeting the stopping rule after ranking round 2. [ Time Frame: Approximately month 5 ]
    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.

  3. The number of statements meeting the stopping rule after ranking round 3. [ Time Frame: Approximately month 5 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899740


Contacts
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Contact: Carey Suehs, PhD +33 (0)4 67 33 63 03 c-suehs@chu-montpellier.fr

Locations
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France
Association Jean Baptiste Desbrest Recruiting
Montpellier, France
Principal Investigator: Carey Suehs, PhD         
Sponsors and Collaborators
Association Jean Baptiste Desbrest
AstraZeneca
Investigators
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Study Director: Carey Suehs, PhD Association Jean Baptiste Desbrest

Additional Information:
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Responsible Party: Association Jean Baptiste Desbrest
ClinicalTrials.gov Identifier: NCT03899740     History of Changes
Other Study ID Numbers: JDB-Delphi-201903
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized data will be shared on an appropriate public platform at the time of publication.
Supporting Materials: Study Protocol
Time Frame: Anonymized data will be shared on an appropriate public platform at the time of publication.
URL: https://osf.io/wrdbu/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases