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NCT01783873
Comparative Study of Pathophysiological Mechanisms and Bronchial Response in Occupational Asthma to Wheat Flour and Quaternary Ammonium Compounds During Standardized Bronchial Provocation Tests
NA trial testing standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™) in Occupational Asthma in 35 participants. Terminated before completion.
12 December 2019
Quick facts
| Lead sponsor | University Hospital, Strasbourg, France |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | other |
| Enrollment | 35 |
| Start date | 1 September 2012 |
| Primary completion | 12 December 2019 |
| Estimated completion | 12 December 2019 |
| Sites | 1 location across France |
Drugs / interventions tested
- standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™)
Conditions studied
- Occupational Asthma — all drugs for Occupational Asthma →
Sponsor
University Hospital, Strasbourg, France
Who can join
Adults 18 to 50, any sex, with Occupational Asthma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Assessment of cellular inflammation in peripheral blood and induced sputum
Time frame: 33 months
Before and after bronchial challenge: assessment of cellular inflammation in peripheral blood and induced sputum, exhaled NO; assessment of peripheral T lymphocyte phenotype.
Sponsor's own description
Occupational asthma (OA) caused by high molecular weight (HMW) substances have been shown to induce predominantly an eosinophilic inflammation. In contrast, OA caused by low molecular weight (LMW) substances results in a neutrophilic inflammation. In addition, data regarding phenotype of lymphocytes in OA caused by HMW and LMW substances are scarce. The use of a new equipment will allow the realization of specific standardized bronchial challenges (BC) to occupational agents. Thus, we propose to study in more detail the cellular mechanisms involved during BC to HMW and LMW occupational agents in a double-blind placebo controlled study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01783873
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01783873 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Strasbourg, France
- Last refreshed: 26 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01783873.
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