Allergic AsthmaNCT01019291
Role of Indoor Pollutants on House Dust Mite Allergic Asthma
A study testing Formaldehyde and NO2 (Exposure to indoor pollutants) in people with Allergic Asthma and Allergy to House Dust Mite, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Asthma, Allergy to House Dust Mite
- What is being tested?
- Formaldehyde and NO2 (Exposure to indoor pollutants)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- M/F 18-50 years of age
- History of intermittent HDM allergic asthma-FEV1 > 80%
- Non smokers or smokers with smoking < 10 PY
Who cannot join
- Persistent asthma and FEV1<80%
- Allergic to pets and pets at home
Trial locations and contacts
1 site in 1 country.
France1 site
Unité de Pneumologie, d'Allergologie et de Pathologie Respiratoire de l'Environnement, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: 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.
- Conditions
- Allergic Asthma, Allergy to House Dust Mite
- Being tested
- Formaldehyde and NO2 (Exposure to indoor pollutants), Placebo (Exposure to indoor pollutants)
- Keywords
- Indoor pollutants
- Medical subject headings
- Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| NO2 | Experimental | NO2 400 µg/m3 Receives: Other: Formaldehyde and NO2 (Exposure to indoor pollutants) |
| Formaldehyde | Experimental | Formaldehyde 100 µg/m3 Receives: Other: Formaldehyde and NO2 (Exposure to indoor pollutants) |
| NO2 + Formaldehyde | Experimental | mixture of Formaldehyde and NO2 Receives: Other: Formaldehyde and NO2 (Exposure to indoor pollutants) |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo (Exposure to indoor pollutants) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- Frederic DE BLAY, MD, Principal investigator, Service de Pneumologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019291
- Sponsor's protocol ID
- 3965
- Status last verified
- Mar 2015
- First submitted
- 23 Nov 2009
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aldehyde and Nitrogen Dioxide at Homes: Measurement of the Exposure and Their Role on Allergic Asthma
- ClinicalTrials.gov ID
- NCT01019291
- Acronym / sponsor ID
- 3965
- Conditions
- Allergic Asthma, Allergy to House Dust Mite
- Keywords
- Indoor pollutants
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- First posted
- 25 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NO2 | Experimental | Other: Formaldehyde and NO2 (Exposure to indoor pollutants)NO2 400 µg/m3 |
| Formaldehyde | Experimental | Other: Formaldehyde and NO2 (Exposure to indoor pollutants)Formaldehyde 100 µg/m3 |
| NO2 + Formaldehyde | Experimental | Other: Formaldehyde and NO2 (Exposure to indoor pollutants)mixture of Formaldehyde and NO2 |
| Placebo | Placebo comparator | Other: Placebo (Exposure to indoor pollutants) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- M/F 18-50 years of age
- History of intermittent HDM allergic asthma-FEV1 > 80%
- Non smokers or smokers with smoking < 10 PY
Key exclusion criteria (2 listed)
- Persistent asthma and FEV1<80%
- Allergic to pets and pets at home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Formaldehyde, NO2, NO2 + Formaldehyde |
| Placebo (Exposure to indoor pollutants)Exposure to indoor pollutants (placebo) in a randomized way, followed by bronchial challenge test with house dust mite extract. | Other | Placebo |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic DE BLAY, MD principal investigator
Service de Pneumologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formaldehyde and NO2 (Exposure to indoor pollutants) in people with Allergic Asthma and Allergy to House Dust Mite, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.