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

NCT03934801 | Completed

• 1 other identifier: RECHMPL19_0195
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Approximately month 5

Secondary Outcomes (3)

• The number of statements meeting the stopping rule after ranking round 1.

  Approximately month 5

• The number of statements meeting the stopping rule after ranking round 2.

  Approximately month 5

• The number of statements meeting the stopping rule after ranking round 3.

  Approximately month 5

Study Arms (1)

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; Other: Ranking Round 1; Other: Ranking Round 2; Other: Ranking Round 3

Interventions

Brainstorming 1 OTHER

Expert recommendation statements will be collected for peer evaluation.

The expert panel

Ranking Round 1 OTHER

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

The expert panel

Ranking Round 2 OTHER

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

The expert panel

Ranking Round 3 OTHER

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

The expert panel

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Association Jean Baptiste Desbrest: collaborator
• AstraZeneca: collaborator

Study Sites (1)

Carey Suehs

Montpellier, 34295, France

Location

Related Publications (2)

• Suehs CM, Bourdin A. Tapering of Oral Corticosteroids for the Treatment of Asthma. Arch Bronconeumol (Engl Ed). 2021 Feb 17:S0300-2896(21)00054-5. doi: 10.1016/j.arbres.2021.01.029. Online ahead of print. No abstract available. English, Spanish.

  PMID: 33722424 BACKGROUND

• Suehs CM, Menzies-Gow A, Price D, Bleecker ER, Canonica GW, Gurnell M, Bourdin A; Oral Corticosteroids Tapering Delphi Expert Panel. Expert Consensus on the Tapering of Oral Corticosteroids for the Treatment of Asthma. A Delphi Study. Am J Respir Crit Care Med. 2021 Apr 1;203(7):871-881. doi: 10.1164/rccm.202007-2721OC.

  PMID: 33112646 RESULT

Related Links

• Description The OCS Tapering Delphi study on the Open Science Framework.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Carey Suehs, PhD

  Association Jean Baptiste Desbrest

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 2, 2019
• Study Start: April 1, 2019
• Primary Completion: September 26, 2019
• Study Completion: September 26, 2019
• Last Updated: March 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Anonymized data will be shared on an appropriate public platform at the time of publication.

Locations

FR (1)