Occupational AsthmaNCT01783873
Comparative Study of Pathophysiological Mechanisms and Bronchial Response in Occupational Asthma to Wheat Flour and Quaternary Ammonium Compounds During Standardized Bronchial Provocation Tests
A study testing standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™) in people with Occupational Asthma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Occupational Asthma
- What is being tested?
- standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to 12 Dec 2019
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- For patients with occupational asthma to wheat flour:
- Clinical history,
- A positive skin test to wheat flour and / or specific IgE to wheat flour
- For patients with occupational asthma to quaternary ammonium compounds:
- -Clinical history,
- For two types of asthma:
- Patients must have a worsening of bronchial hyperreactivity during work compared to a rest period assessed by a metacholine challenge
- FEV before challenge (nonspecific and specific) must be> 70%.
Who cannot join
- Asthmas:
- no occupational asthma:
- secondary to clinically relevant sensitization to an allergen domestic
- aggravated at work.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Occupational Asthma
- Being tested
- standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™)
- Medical subject headings
- Asthma, Occupational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™)Other
At Visit 1: Patients are selected and they will receive a metacholine challenge test during and outside of work. After randomization, patients undergo a standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™) to either an wheat flour allergen extract or didecyldimethylammonium chloride or placebo. Each bronchial challenge test is followed by blood sampling at different time points and induced sputum. The immediate bronchial response and late bronchial response will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™) |
| flour allergen extract or quaternary ammonium compound | Active comparator | Not described Receives: Other: standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of cellular inflammation in peripheral blood and induced sputum
Before and after bronchial challenge: assessment of cellular inflammation in peripheral blood and induced sputum, exhaled NO; assessment of peripheral T lymphocyte phenotype.
Measured: 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startSep 2012
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Why it stopped: recruitement difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational AsthmaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric De BLAY, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783873
- Sponsor's protocol ID
- 4707
- Status last verified
- Aug 2019
- First submitted
- 28 Jan 2013
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Pathophysiological Mechanisms and Bronchial Response in Occupational Asthma to Wheat Flour and Quaternary Ammonium Compounds During Standardized Bronchial Provocation Tests
- ClinicalTrials.gov ID
- NCT01783873
- Acronym / sponsor ID
- 4707
- Conditions
- Occupational Asthma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitement difficulty
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 5 Feb 2013 (estimated)
- 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™) |
| flour allergen extract or quaternary ammonium compound | Active comparator | Other: standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Clinical history,
- A positive skin test to wheat flour and / or specific IgE to wheat flour
- -Clinical history,
- Patients must have a worsening of bronchial hyperreactivity during work compared to a rest period assessed by a metacholine challenge
- FEV before challenge (nonspecific and specific) must be> 70%.
Key exclusion criteria (4 listed)
- no occupational asthma:
- secondary to clinically relevant sensitization to an allergen domestic
- aggravated at work.
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 |
|---|---|---|
| standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™)At Visit 1: Patients are selected and they will receive a metacholine challenge test during and outside of work. After randomization, patients undergo a standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™) to either an wheat flour allergen extract or didecyldimethylammonium chloride or placebo. Each bronchial challenge test is followed by blood sampling at different time points and induced sputum. The immediate bronchial response and late bronchial response will be recorded. | Other | Placebo, flour allergen extract or quaternary ammonium compound |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: recruitement difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
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.
Frédéric De BLAY, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™) in people with Occupational Asthma, run by University Hospital, Strasbourg, France 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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 29 Jun 2020. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: recruitement difficulty). 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?
Assessment of cellular inflammation in peripheral blood and induced sputum (time frame: 33 months). 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 29 Jun 2020.