AsthmaNOnourissonNCT01239199
Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma ?
A study testing Measure of the exhaled NO in people with Asthma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Background: It seems that in the infants and the young children, the increase of the Exhaled Nitric Oxide (eNO) is in connection with: (1) the risk of developing respiratory symptoms; (2) the risk of family and personal atopy; (3) the intensity of the respiratory symptoms; (4) the risk of passage of recurrent wheezing… Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Asthma
- What is being tested?
- Measure of the exhaled NO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to May 2011
- 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 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant between 6 and 36 months
- More than 3 wheezing episodes
- Questionary and biological assessment for recurrent wheeze
- Signature of the consent by 2 parents or by the only one of 2 parents (if this last one is the only present in the inclusion of the child)
Who cannot join
- Infant with respiratory disease in neonatal period
- Infant with other obstructive pathology (cystic fibrosis, Primary Ciliary Dyskinesia,…)
- Infant who have a respiratory infection less than 4 weeks
- Infant with asthma exacerbation or who still have corticosteroid treatment
- Infant without social security from their parents
Trial locations and contacts
1 site in 1 country.
France1 site
Service of multidisciplinary paediatrics (Armand-Trousseau Hospital)
Paris, Île-de-France Region, 75012
About this study
Official title: Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma?
Background:
It seems that in the infants and the young children, the increase of the Exhaled Nitric Oxide (eNO) is in connection with: (1) the risk of developing respiratory symptoms; (2) the risk of family and personal atopy; (3) the intensity of the respiratory symptoms; (4) the risk of passage of recurrent wheezing to asthma; (5) and contrary to the fact that the investigators noticed at the child's a positive relation with the environmental tobacco smoke
Objective: the investigators objective is to bring to light that the rise of the eNO, a non invasive biomarker of the bronchial inflammation, would be a risk factor expected from passage of recurrent wheezing of the infant and the young child (of less than 36 months old) towards the asthma of the child.Methods: Once the diagnosis of recurrent wheezing established, the investigators estimate by questionnaire the severity of the asthma, the personal and familial atopy, the collection of the environmental data. After allergic exploration (skin tests and assay of serum total and specific IgE, complete blood count), the eNO is measured by an off-line tidal breathing method using a chemiluminescence NO analyzer. Annually, a questionnaire will be send to families to appreciate the persistence or the remission of the asthma. After a simple descriptive analysis of the population and a multifactorial descriptive analysis, the investigators shall look for the connections between the rise of the eNO and the various clinical, biological and environmental parameters known to influence the variations of this marker. Then the investigators shall select a set of explanatory variables for a multivariate analysis by a logistic regression step by step.
Read the detailed description
This study is a epidemiological observation study
- Conditions
- Asthma
- Being tested
- Measure of the exhaled NO
- Keywords
- Infants, Exhaled Nitric Oxide, Asthma, Tobacco smoke exposure, environment
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of the exhaled NOOther
The exhaled NO will be measure by chemiluminescence in current ventilation by an indirect method (off-line)
| Study group | Role | What they receive |
|---|---|---|
| Exhaled NO | Experimental | Not described Receives: Other: Measure of the exhaled NO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of exhaled nitric oxide at the beginning of the study and incidence of asthma symptoms after 3 years of follow up
Measured: 1 day
Secondary outcomes (1)
Atopic status with total and specific IgE levels and skin test, complete blood count
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (76)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jocelyne Just, Principal investigator, Trousseau Hospital - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239199
- Sponsor's protocol ID
- P 070802
- Acronym
- NOnourisson
- Status last verified
- Feb 2014
- First submitted
- 21 Oct 2010
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lowe L, Custovic A, Woodcock A. Childhood asthma. Curr Allergy Asthma Rep. 2004 Mar;4(2):159-65. doi: 10.1007/s11882-004-0062-9.
PubMed 14769266Saglani S, Nicholson AG, Scallan M, Balfour-Lynn I, Rosenthal M, Payne DN, Bush A. Investigation of young children with severe recurrent wheeze: any clinical benefit? Eur Respir J. 2006 Jan;27(1):29-35. doi: 10.1183/09031936.06.00030605.
PubMed 16387932Pohunek P, Warner JO, Turzikova J, Kudrmann J, Roche WR. Markers of eosinophilic inflammation and tissue re-modelling in children before clinically diagnosed bronchial asthma. Pediatr Allergy Immunol. 2005 Feb;16(1):43-51. doi: 10.1111/j.1399-3038.2005.00239.x.
PubMed 15693911Franklin PJ, Turner SW, Mutch RC, Stick SM. Comparison of single-breath and tidal breathing exhaled nitric oxide levels in infants. Eur Respir J. 2004 Mar;23(3):369-72. doi: 10.1183/09031936.04.00084604.
PubMed 15065823Yang H, Wei W, Menconi M, Hasselgren PO. Dexamethasone-induced protein degradation in cultured myotubes is p300/HAT dependent. Am J Physiol Regul Integr Comp Physiol. 2007 Jan;292(1):R337-4. doi: 10.1152/ajpregu.00230.2006. Epub 2006 Sep 14.
PubMed 16973938Baraldi E, Dario C, Ongaro R, Scollo M, Azzolin NM, Panza N, Paganini N, Zacchello F. Exhaled nitric oxide concentrations during treatment of wheezing exacerbation in infants and young children. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1284-8. doi: 10.1164/ajrccm.159.4.9807084.
PubMed 10194178American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.
PubMed 15817806Phelan PD, Robertson CF, Olinsky A. The Melbourne Asthma Study: 1964-1999. J Allergy Clin Immunol. 2002 Feb;109(2):189-94. doi: 10.1067/mai.2002.120951.
PubMed 11842286Zeiger RS, Dawson C, Weiss S. Relationships between duration of asthma and asthma severity among children in the Childhood Asthma Management Program (CAMP). J Allergy Clin Immunol. 1999 Mar;103(3 Pt 1):376-87. doi: 10.1016/s0091-6749(99)70460-4.
PubMed 10069869Harris JR, Magnus P, Samuelsen SO, Tambs K. No evidence for effects of family environment on asthma. A retrospective study of Norwegian twins. Am J Respir Crit Care Med. 1997 Jul;156(1):43-9. doi: 10.1164/ajrccm.156.1.9609094.
PubMed 9230724Martinez FD, Wright AL, Taussig LM, Holberg CJ, Halonen M, Morgan WJ. Asthma and wheezing in the first six years of life. The Group Health Medical Associates. N Engl J Med. 1995 Jan 19;332(3):133-8. doi: 10.1056/NEJM199501193320301.
PubMed 7800004Young S, Le Souef PN, Geelhoed GC, Stick SM, Turner KJ, Landau LI. The influence of a family history of asthma and parental smoking on airway responsiveness in early infancy. N Engl J Med. 1991 Apr 25;324(17):1168-73. doi: 10.1056/NEJM199104253241704.
PubMed 2011160Murray CS, Pipis SD, McArdle EC, Lowe LA, Custovic A, Woodcock A; National Asthma Campaign-Manchester Asthma and Allergy Study Group. Lung function at one month of age as a risk factor for infant respiratory symptoms in a high risk population. Thorax. 2002 May;57(5):388-92. doi: 10.1136/thorax.57.5.388.
PubMed 11978912Wahn U, Lau S, Bergmann R, Kulig M, Forster J, Bergmann K, Bauer CP, Guggenmoos-Holzmann I. Indoor allergen exposure is a risk factor for sensitization during the first three years of life. J Allergy Clin Immunol. 1997 Jun;99(6 Pt 1):763-9. doi: 10.1016/s0091-6749(97)80009-7.
PubMed 9215243Sears MR, Herbison GP, Holdaway MD, Hewitt CJ, Flannery EM, Silva PA. The relative risks of sensitivity to grass pollen, house dust mite and cat dander in the development of childhood asthma. Clin Exp Allergy. 1989 Jul;19(4):419-24. doi: 10.1111/j.1365-2222.1989.tb02408.x.
PubMed 2758355
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma?
- ClinicalTrials.gov ID
- NCT01239199
- Acronym / sponsor ID
- NOnourisson / P 070802
- Conditions
- Asthma
- Keywords
- Infants, Exhaled Nitric Oxide, Asthma, Tobacco smoke exposure, environment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 11 Nov 2010 (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.
Background:
It seems that in the infants and the young children, the increase of the Exhaled Nitric Oxide (eNO) is in connection with: (1) the risk of developing respiratory symptoms; (2) the risk of family and personal atopy; (3) the intensity of the respiratory symptoms; (4) the risk of passage of recurrent wheezing to asthma; (5) and contrary to the fact that the investigators noticed at the child's a positive relation with the environmental tobacco smoke
Objective: the investigators objective is to bring to light that the rise of the eNO, a non invasive biomarker of the bronchial inflammation, would be a risk factor expected from passage of recurrent wheezing of the infant and the young child (of less than 36 months old) towards the asthma of the child.Methods: Once the diagnosis of recurrent wheezing established, the investigators estimate by questionnaire the severity of the asthma, the personal and familial atopy, the collection of the environmental data. After allergic exploration (skin tests and assay of serum total and specific IgE, complete blood count), the eNO is measured by an off-line tidal breathing method using a chemiluminescence NO analyzer. Annually, a questionnaire will be send to families to appreciate the persistence or the remission of the asthma. After a simple descriptive analysis of the population and a multifactorial descriptive analysis, the investigators shall look for the connections between the rise of the eNO and the various clinical, biological and environmental parameters known to influence the variations of this marker. Then the investigators shall select a set of explanatory variables for a multivariate analysis by a logistic regression step by step.
Detailed description
This study is a epidemiological observation study
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exhaled NO | Experimental | Other: Measure of the exhaled NO |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infant between 6 and 36 months
- More than 3 wheezing episodes
- Questionary and biological assessment for recurrent wheeze
- Signature of the consent by 2 parents or by the only one of 2 parents (if this last one is the only present in the inclusion of the child)
Key exclusion criteria (5 listed)
- Infant with respiratory disease in neonatal period
- Infant with other obstructive pathology (cystic fibrosis, Primary Ciliary Dyskinesia,…)
- Infant who have a respiratory infection less than 4 weeks
- Infant with asthma exacerbation or who still have corticosteroid treatment
- Infant without social security from their parents
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 |
|---|---|---|
| Measure of the exhaled NOThe exhaled NO will be measure by chemiluminescence in current ventilation by an indirect method (off-line) | Other | Exhaled NO |
Primary outcome
Measure of exhaled nitric oxide at the beginning of the study and incidence of asthma symptoms after 3 years of follow up
Time frame: 1 day
1 secondary outcome
Atopic status with total and specific IgE levels and skin test, complete blood count
Time frame: 1 day
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 27 Feb 2014.
- Background: PubMed 14769266Lowe L, Custovic A, Woodcock A. Childhood asthma. Curr Allergy Asthma Rep. 2004 Mar;4(2):159-65. doi: 10.1007/s11882-004-0062-9.
- Background: PubMed 16387932Saglani S, Nicholson AG, Scallan M, Balfour-Lynn I, Rosenthal M, Payne DN, Bush A. Investigation of young children with severe recurrent wheeze: any clinical benefit? Eur Respir J. 2006 Jan;27(1):29-35. doi: 10.1183/09031936.06.00030605.
- Background: PubMed 15693911Pohunek P, Warner JO, Turzikova J, Kudrmann J, Roche WR. Markers of eosinophilic inflammation and tissue re-modelling in children before clinically diagnosed bronchial asthma. Pediatr Allergy Immunol. 2005 Feb;16(1):43-51. doi: 10.1111/j.1399-3038.2005.00239.x.
- Background: PubMed 15065823Franklin PJ, Turner SW, Mutch RC, Stick SM. Comparison of single-breath and tidal breathing exhaled nitric oxide levels in infants. Eur Respir J. 2004 Mar;23(3):369-72. doi: 10.1183/09031936.04.00084604.
- Background: PubMed 16973938Yang H, Wei W, Menconi M, Hasselgren PO. Dexamethasone-induced protein degradation in cultured myotubes is p300/HAT dependent. Am J Physiol Regul Integr Comp Physiol. 2007 Jan;292(1):R337-4. doi: 10.1152/ajpregu.00230.2006. Epub 2006 Sep 14.
- Background: PubMed 10194178Baraldi E, Dario C, Ongaro R, Scollo M, Azzolin NM, Panza N, Paganini N, Zacchello F. Exhaled nitric oxide concentrations during treatment of wheezing exacerbation in infants and young children. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1284-8. doi: 10.1164/ajrccm.159.4.9807084.
- Background: PubMed 15817806American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.
- Background: PubMed 11842286Phelan PD, Robertson CF, Olinsky A. The Melbourne Asthma Study: 1964-1999. J Allergy Clin Immunol. 2002 Feb;109(2):189-94. doi: 10.1067/mai.2002.120951.
- Background: PubMed 10069869Zeiger RS, Dawson C, Weiss S. Relationships between duration of asthma and asthma severity among children in the Childhood Asthma Management Program (CAMP). J Allergy Clin Immunol. 1999 Mar;103(3 Pt 1):376-87. doi: 10.1016/s0091-6749(99)70460-4.
- Background: PubMed 9230724Harris JR, Magnus P, Samuelsen SO, Tambs K. No evidence for effects of family environment on asthma. A retrospective study of Norwegian twins. Am J Respir Crit Care Med. 1997 Jul;156(1):43-9. doi: 10.1164/ajrccm.156.1.9609094.
- Background: PubMed 7800004Martinez FD, Wright AL, Taussig LM, Holberg CJ, Halonen M, Morgan WJ. Asthma and wheezing in the first six years of life. The Group Health Medical Associates. N Engl J Med. 1995 Jan 19;332(3):133-8. doi: 10.1056/NEJM199501193320301.
- Background: PubMed 2011160Young S, Le Souef PN, Geelhoed GC, Stick SM, Turner KJ, Landau LI. The influence of a family history of asthma and parental smoking on airway responsiveness in early infancy. N Engl J Med. 1991 Apr 25;324(17):1168-73. doi: 10.1056/NEJM199104253241704.
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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 principal investigator
Trousseau Hospital - APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measure of the exhaled NO in people with 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 4 inclusion and 5 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 27 Feb 2014. 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?
Measure of exhaled nitric oxide at the beginning of the study and incidence of asthma symptoms after 3 years of follow up (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01239199, which also lists 76 linked publications.
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 Feb 2014.