AsthmaNOLNNCT00773578
Exhaled Nitric Oxide and Nasal Lavage Fluid
An observational study of Asthma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The allergic respiratory diseases such as asthma or allergic rhinitis are the main chronic diseases in children. The airway inflammation plays an important role in their pathophysiology. Several epidemiological studies show that environmental tobacco smoke (ETS) exacerbates the symptoms of asthma and allergies. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Asthma
- What is being tested?
- Measurement of exhaled nitric oxide (eNO) and Measurement of biomarkers of nasal inflammation
- Type of treatment
- Medical device
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2007to Feb 2009
- Phase
- Observational
- 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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Atopic asthmatic children followed in the Asthma Center, Trousseau Hospital, Paris
Who may be able to join
- Aged over 5 years
- Atopic, persistent mild and moderate Asthmatic Children (GINA 2 and 3)
Who cannot join
- Child with asthma medication asthma used in the previous 15 days (oral or inhaled corticosteroids, leukotriene antagonist)
- Recent asthma attack (day of hospitalization or 15 days earlier)
- Upper respiratory infection (4 weeks) and low (2 weeks)
- Active smoking (teenager)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Environmental Tobacco Smoke on Exhaled Nitric Oxide and on Biomarkers of Nasal Inflammation in Atopic Asthmatic Children
The allergic respiratory diseases such as asthma or allergic rhinitis are the main chronic diseases in children. The airway inflammation plays an important role in their pathophysiology. Several epidemiological studies show that environmental tobacco smoke (ETS) exacerbates the symptoms of asthma and allergies.
The aim of this study is to assess the impact of environmental tobacco smoke on the measurement of exhaled nitric oxide (eNO) and biomarkers of nasal inflammation in atopic asthmatic children.
Read the detailed description
Type of study :
This study is a epidemiological observation study type exposed or unexposed to environmental tobacco smoke.
Methods :
The eNO is determined by a method On-line, at a rate expiratory 50 mL / s, using a chemiluminescence NO analyzer, before the allergy assessment (skin tests and assay of serum total and specific IgE ) and measurement of lung function (spirometry). Nasal lavage is performed by using a validated technique . Cells are counted and differentiated after Giemsa staining. We measured 1-anti-trypsin, neutrophil elastase, albumin, urea, IL4 , IL6, IL8 and IL13. Exposure to ETS is assessed by questionnaire to the parents. Statistical analysis include a narrative strand to verify the normality of distribution and an analytical analysis, including a bivariate followed by a multivariate analysis by multiple linear regression and / or logistic regression to model concentrations of biomarkers of inflammation and adjustment variables such as age, sex, atopic status, eosinophilia and severity of asthma.
- Conditions
- Asthma
- Being tested
- Measurement of exhaled nitric oxide (eNO), Measurement of biomarkers of nasal inflammation
- Keywords
- Children, Tobacco smoke exposure, Exhaled nitric oxide, Nasal lavage, Cytokines
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of exhaled nitric oxide (eNO)Device
Chemiluminescence NO analyzer Measurement of lung function (spirometry)
Measurement of biomarkers of nasal inflammationDevice
Nasal lavage
| Study group | Role | What they receive |
|---|---|---|
| 1 | atopic asthmatic children exposed to environmental tobacco smoke Receives: Device: Measurement of exhaled nitric oxide (eNO); Device: Measurement of biomarkers of nasal inflammation | |
| 2 | atopic asthmatic children unexposed to environmental tobacco smoke Receives: Device: Measurement of exhaled nitric oxide (eNO); Device: Measurement of biomarkers of nasal inflammation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the impact of environmental tobacco smoke on the measurement of exhaled nitric oxide and the nasal inflammation biomarkers, in atopic asthmatic children aged over 5 years
Measured: at the inclusion visit
Secondary outcomes (1)
Evaluation of the possible association between nasal inflammation (objectified by the determination of biomarkers in the nasal lavage fluid) and bronchial (measurement of exhaled nitric oxide).
Measured: At the inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startOct 2007
- Primary completionSep 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Jocelyne JUST, MdPh, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773578
- Sponsor's protocol ID
- P070201
- Other IDs
- AOR05005
- Acronym
- NOLN
- Status last verified
- Feb 2009
- First submitted
- 15 Oct 2008
- Last updated
- 13 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Environmental Tobacco Smoke on Exhaled Nitric Oxide and on Biomarkers of Nasal Inflammation in Atopic Asthmatic Children
- ClinicalTrials.gov ID
- NCT00773578
- Acronym / sponsor ID
- NOLN / P070201
- Conditions
- Asthma
- Keywords
- Children, Tobacco smoke exposure, Exhaled nitric oxide, Nasal lavage, Cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 16 Oct 2008 (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.
The allergic respiratory diseases such as asthma or allergic rhinitis are the main chronic diseases in children. The airway inflammation plays an important role in their pathophysiology. Several epidemiological studies show that environmental tobacco smoke (ETS) exacerbates the symptoms of asthma and allergies.
The aim of this study is to assess the impact of environmental tobacco smoke on the measurement of exhaled nitric oxide (eNO) and biomarkers of nasal inflammation in atopic asthmatic children.
Detailed description
Type of study :
This study is a epidemiological observation study type exposed or unexposed to environmental tobacco smoke.
Methods :
The eNO is determined by a method On-line, at a rate expiratory 50 mL / s, using a chemiluminescence NO analyzer, before the allergy assessment (skin tests and assay of serum total and specific IgE ) and measurement of lung function (spirometry). Nasal lavage is performed by using a validated technique . Cells are counted and differentiated after Giemsa staining. We measured 1-anti-trypsin, neutrophil elastase, albumin, urea, IL4 , IL6, IL8 and IL13. Exposure to ETS is assessed by questionnaire to the parents. Statistical analysis include a narrative strand to verify the normality of distribution and an analytical analysis, including a bivariate followed by a multivariate analysis by multiple linear regression and / or logistic regression to model concentrations of biomarkers of inflammation and adjustment variables such as age, sex, atopic status, eosinophilia and severity of asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Measurement of exhaled nitric oxide (eNO), Device: Measurement of biomarkers of nasal inflammationatopic asthmatic children exposed to environmental tobacco smoke |
| 2 | – | Device: Measurement of exhaled nitric oxide (eNO), Device: Measurement of biomarkers of nasal inflammationatopic asthmatic children unexposed to environmental tobacco smoke |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Atopic asthmatic children followed in the Asthma Center, Trousseau Hospital, Paris
Key inclusion criteria (2 listed)
- Aged over 5 years
- Atopic, persistent mild and moderate Asthmatic Children (GINA 2 and 3)
Key exclusion criteria (4 listed)
- Child with asthma medication asthma used in the previous 15 days (oral or inhaled corticosteroids, leukotriene antagonist)
- Recent asthma attack (day of hospitalization or 15 days earlier)
- Upper respiratory infection (4 weeks) and low (2 weeks)
- Active smoking (teenager)
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 |
|---|---|---|
| Measurement of exhaled nitric oxide (eNO)Chemiluminescence NO analyzer Measurement of lung function (spirometry) | Device | 1, 2 |
| Measurement of biomarkers of nasal inflammationNasal lavage | Device | 1, 2 |
Primary outcome
Assessment of the impact of environmental tobacco smoke on the measurement of exhaled nitric oxide and the nasal inflammation biomarkers, in atopic asthmatic children aged over 5 years
Time frame: at the inclusion visit
1 secondary outcome
Evaluation of the possible association between nasal inflammation (objectified by the determination of biomarkers in the nasal lavage fluid) and bronchial (measurement of exhaled nitric oxide).
Time frame: At the inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2009.
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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.
Jocelyne JUST, MdPh principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 13 Feb 2009. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Assessment of the impact of environmental tobacco smoke on the measurement of exhaled nitric oxide and the nasal inflammation biomarkers, in atopic asthmatic children aged over 5 years (time frame: at the inclusion visit). It is what the study was designed to measure, not a finding.
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 13 Feb 2009.