- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01019291
Role of Indoor Pollutants on House Dust Mite Allergic Asthma
March 26, 2015 updated by: University Hospital, Strasbourg, France
Aldehyde and Nitrogen Dioxide at Homes: Measurement of the Exposure and Their Role on Allergic Asthma
It seems that the aldehydes and NO2, at the levels found indoor, could be the aggravating factors for an allergic response.
However this effect has not been demonstrated.
The investigators plan to study the effect of exposure to standard doses of these pollutants on the bronchial reactivity as measured by bronchial challenge tests with dust mite extract in volunteers asthmatic, allergic to house dust mite.
Study Overview
Status
Withdrawn
Conditions
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Strasbourg, France, 67091
- Unité de Pneumologie, d'Allergologie et de Pathologie Respiratoire de l'Environnement, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- M/F 18-50 years of age
- History of intermittent HDM allergic asthma-FEV1 > 80%
- Non smokers or smokers with smoking < 10 PY
Exclusion criteria:
- Persistent asthma and FEV1<80%
- Allergic to pets and pets at home
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Exposure to indoor pollutants (placebo) in a randomized way, followed by bronchial challenge test with house dust mite extract.
|
Experimental: NO2
NO2 400 µg/m3
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Exposure to indoor pollutants (Formaldehyde and NO2) in a randomized way, followed by bronchial challenge test with house dust mite extract.
|
Experimental: Formaldehyde
Formaldehyde 100 µg/m3
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Exposure to indoor pollutants (Formaldehyde and NO2) in a randomized way, followed by bronchial challenge test with house dust mite extract.
|
Experimental: NO2 + Formaldehyde
mixture of Formaldehyde and NO2
|
Exposure to indoor pollutants (Formaldehyde and NO2) in a randomized way, followed by bronchial challenge test with house dust mite extract.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Frederic DE BLAY, MD, Service de Pneumologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 7, 2022
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
November 23, 2009
First Submitted That Met QC Criteria
November 23, 2009
First Posted (Estimate)
November 25, 2009
Study Record Updates
Last Update Posted (Estimate)
March 27, 2015
Last Update Submitted That Met QC Criteria
March 26, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3965
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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