Role of Indoor Pollutants on House Dust Mite Allergic Asthma

NCT ID: NCT01019291

Last Updated: 2015-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Asthma Allergy to House Dust Mite

Study Design

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Allocation Method

RANDOMIZED

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NO2

NO2 400 µg/m3

Group Type EXPERIMENTAL

Formaldehyde and NO2 (Exposure to indoor pollutants)

Intervention Type OTHER

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

Formaldehyde

Formaldehyde 100 µg/m3

Group Type EXPERIMENTAL

Formaldehyde and NO2 (Exposure to indoor pollutants)

Intervention Type OTHER

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

NO2 + Formaldehyde

mixture of Formaldehyde and NO2

Group Type EXPERIMENTAL

Formaldehyde and NO2 (Exposure to indoor pollutants)

Intervention Type OTHER

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo (Exposure to indoor pollutants)

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Hôpitaux Universitaires de Strasbourg

Principal Investigators

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Frederic DE BLAY, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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3965

Identifier Type: -

Identifier Source: org_study_id

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