Occupational AsthmaNCT03568305
Characterization of Phenotypes of Occupational Asthma
An observational study of Occupational Asthma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The general objective of this multicenter, international study is to perform a multivariate descriptive analysis of a large population of well-defined subjects with sensitizer-induced OA ascertained by a positive SIC result in order to provide more information on the characteristics of this condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occupational Asthma
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2017to Jun 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who performed a specific inhalation test with a positive result between january 2006 and december 2015.- Subject giving their consent for their participation
Who may be able to join
- Adult Patient
- Patient who performed a specific inhalation test with a positive result between January 2006 and December 2015.- Subject giving their consent for their participation
- Patient agreeing to use his data for research purposes
Who cannot join
- Patient objecting to the use of his data for research purposes
- Subjects under safeguard of justice
- Subject under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de pneumologie, d'allergologie et de pathologie de l'environnement
Strasbourg, 67091
Frédéric De Blay, MD, PhD, 33.3.69.55.06.39, frederic.deblay@chru-strasbourg.fr
About this study
Official title: Characterization of Phenotypes of Occupational Asthma: Descriptive Study
The general objective of this multicenter, international study is to perform a multivariate descriptive analysis of a large population of well-defined subjects with sensitizer-induced OA ascertained by a positive SIC result in order to provide more information on the characteristics of this condition.
- Conditions
- Occupational Asthma
- Keywords
- asthma, occupational asthma
- Medical subject headings
- Asthma, Occupational, Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study to perform a multi-varied descriptive analysis of a cohort of patients with occupational asthma confirmed by a specific inhalation test
Measured: The period from from January 1st, 2006 to December 31st, 2015 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Jun 2017
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric De Blay, MD, PhD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568305
- Sponsor's protocol ID
- 6513
- Status last verified
- Jun 2017
- First submitted
- 14 Jun 2018
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Phenotypes of Occupational Asthma: Descriptive Study
- ClinicalTrials.gov ID
- NCT03568305
- Acronym / sponsor ID
- 6513
- Conditions
- Occupational Asthma
- Keywords
- asthma, occupational asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 26 Jun 2018 (actual)
- 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.
The general objective of this multicenter, international study is to perform a multivariate descriptive analysis of a large population of well-defined subjects with sensitizer-induced OA ascertained by a positive SIC result in order to provide more information on the characteristics of this condition.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who performed a specific inhalation test with a positive result between january 2006 and december 2015.- Subject giving their consent for their participation
Key inclusion criteria (3 listed)
- Adult Patient
- Patient who performed a specific inhalation test with a positive result between January 2006 and December 2015.- Subject giving their consent for their participation
- Patient agreeing to use his data for research purposes
Key exclusion criteria (3 listed)
- Patient objecting to the use of his data for research purposes
- Subjects under safeguard of justice
- Subject under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective study to perform a multi-varied descriptive analysis of a cohort of patients with occupational asthma confirmed by a specific inhalation test
Time frame: The period from from January 1st, 2006 to December 31st, 2015 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
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, PhD study director
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?
An observational study of 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jun 2018. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frédéric De Blay, MD, PhD (33.3.69.55.06.39, frederic.deblay@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study to perform a multi-varied descriptive analysis of a cohort of patients with occupational asthma confirmed by a specific inhalation test (time frame: The period from from January 1st, 2006 to December 31st, 2015 will be examined). 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 27 Jun 2018.