NCT01019291

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

First QC Date

November 23, 2009

Last Update Submit

March 26, 2015

Conditions

Allergic AsthmaAllergy to House Dust Mite

Keywords

Indoor pollutants

Study Arms (4)

NO2

EXPERIMENTAL

NO2 400 µg/m3

Other: Formaldehyde and NO2 (Exposure to indoor pollutants)

Formaldehyde

EXPERIMENTAL

Formaldehyde 100 µg/m3

Other: Formaldehyde and NO2 (Exposure to indoor pollutants)

NO2 + Formaldehyde

EXPERIMENTAL

mixture of Formaldehyde and NO2

Other: Formaldehyde and NO2 (Exposure to indoor pollutants)

Placebo

PLACEBO COMPARATOR
Other: Placebo (Exposure to indoor pollutants)

Interventions

Formaldehyde and NO2 (Exposure to indoor pollutants)OTHER

Exposure to indoor pollutants (Formaldehyde and NO2) in a randomized way, followed by bronchial challenge test with house dust mite extract.

FormaldehydeNO2NO2 + Formaldehyde
Placebo (Exposure to indoor pollutants)OTHER

Exposure to indoor pollutants (placebo) in a randomized way, followed by bronchial challenge test with house dust mite extract.

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • M/F 18-50 years of age
  • History of intermittent HDM allergic asthma-FEV1 \> 80%
  • Non smokers or smokers with smoking \< 10 PY

You may not qualify if:

  • Persistent asthma and FEV1\<80%
  • Allergic to pets and pets at home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de Pneumologie, d'Allergologie et de Pathologie Respiratoire de l'Environnement, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Dust Mite Allergy

Interventions

Formaldehyde

Condition Hierarchy (Ancestors)

Rhinitis, Allergic, PerennialRhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AldehydesOrganic Chemicals

Study Officials

  • Frederic DE BLAY, MD

    Service de Pneumologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 23, 2009

First Posted

November 25, 2009

Last Updated

March 27, 2015

Record last verified: 2015-03

Locations

FR(1)