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Role of Indoor Pollutants on House Dust Mite Allergic Asthma

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01019291
First Posted: November 25, 2009
Last Update Posted: March 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Strasbourg, France
  Purpose
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.

Condition Intervention
Allergic Asthma Allergy to House Dust Mite Other: Formaldehyde and NO2 (Exposure to indoor pollutants) Other: Placebo (Exposure to indoor pollutants)

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double (Participant, Investigator)
Official Title: Aldehyde and Nitrogen Dioxide at Homes: Measurement of the Exposure and Their Role on Allergic Asthma

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Enrollment: 0
Arms Assigned Interventions
Experimental: NO2
NO2 400 µg/m3
Other: Formaldehyde and NO2 (Exposure to indoor pollutants)
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
Other: Formaldehyde and NO2 (Exposure to indoor pollutants)
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
Other: Formaldehyde and NO2 (Exposure to indoor pollutants)
Exposure to indoor pollutants (Formaldehyde and NO2) in a randomized way, followed by bronchial challenge test with house dust mite extract.
Placebo Comparator: Placebo Other: Placebo (Exposure to indoor pollutants)
Exposure to indoor pollutants (placebo) in a randomized way, followed by bronchial challenge test with house dust mite extract.

  Eligibility

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019291


Locations
France
Unité de Pneumologie, d'Allergologie et de Pathologie Respiratoire de l'Environnement, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Frederic DE BLAY, MD Service de Pneumologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
  More Information

Responsible Party: Christine GEILLER, Directeur de la Recherche Clinique et des Innovations, Hôpitaux Universitaires de Strasbourg
ClinicalTrials.gov Identifier: NCT01019291     History of Changes
Other Study ID Numbers: 3965
First Submitted: November 23, 2009
First Posted: November 25, 2009
Last Update Posted: March 27, 2015
Last Verified: March 2015

Keywords provided by University Hospital, Strasbourg, France:
Indoor pollutants

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formaldehyde
Disinfectants
Anti-Infective Agents