Role of Indoor Pollutants on House Dust Mite Allergic Asthma

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01019291
First received: November 23, 2009
Last updated: July 27, 2011
Last verified: July 2011
  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 Blind (Subject, 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:

Estimated Enrollment: 25
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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 23, 2009
Last Updated: July 27, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014