T2 Biomarkers Predictive Value in Occupational Asthma After Cessation of Exposure.

NCT07006285 | Not Yet Recruiting

• 1 other identifier: 9224
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Occupational exposure is known to cause 15% of asthma cases. The main treatment for occupational asthma is to stop exposure if possible. Although, remission of occupational asthma only occurs in only 30 % of patients after cessation of exposure. There is currently no way of predicting which patients will go into remission after cessation of exposure. In non-occupational asthma, the inflammatory biomarker T2 has allowed the entry into personalized medicine and can predict future exacerbations. The investigators hypothesize that T2 biomarkers could be predictive markers for remission in occupational asthma after exposure cessation. The investigators intend to carry out a follow-up study at the University Hospital of Strasbourg to perform the non-specific bronchial hyperresponsiveness test to assess remission in patients diagnosed with occupational asthma and to compare baseline T2 biomarkers in remission and non remission patients.

Conditions

Asthma; Occupational Asthma; Occupational Diseases

Outcome Measures

Primary Outcomes (2)

• Remission of occupational asthma

  Remission of occupational asthma is defined by absence of nonspecific bronchial hyperresponsiveness. Assessment of nonspecific bronchial hyperresponsiveness is realized by metacholine challenge

  Day 1

• Comparison of TH2-type inflammation levels

  To compare the level of Th2-type inflammation in sputum from patients in remission versus patients with persistent asthma.

  Day 1

Secondary Outcomes (1)

• Remission of occupational rhinitis

  Day 1

Study Arms (1)

patients with occupational asthma

OTHER

Other: Measure of T2 biomarkers

Interventions

Measure of T2 biomarkers OTHER

T2 Biomarkers are estimated via induced sputum: Sputum is induced through increasing concentrations from 0.9 or 3% to 4% and 5% of hypertonic solution. Assessment of nonspecific bronchial hyperresponsiveness is realized by metacholine challenge

patients with occupational asthma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18
• Diagnosis of occupational asthma by specific inhalation challenge
• Exposure to sensitizing agent avoided or reduced
• Able to understand the aims and risks of the research and to give free and informed consent
• For women of childbearing age: effective contraception in progress.
• Benefiting from social security coverage

You may not qualify if:

• Impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject)
• Subject under court protection
• Subject under guardianship or curatorship
• Pregnant or breast-feeding patient

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

University Hospital of Strasbourg

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Asthma; Asthma, Occupational; Occupational Diseases

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Naji KHAYATH, Doctor

CONTACT

3 69 55 09 02; naji.khayath@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: June 5, 2025
• Study Start: June 1, 2025
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)