BronchiolitisNCT00676351
Follow up of Ventilatory Function in Infant After Bronchiolitis During the First Year of Life
A study testing body plethysmography in people with Bronchiolitis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
A significant proportion of asthma is diagnosed during childhood. Bronchiolitis is the most common lower respiratory tract illness (LRI) in early life and the present work is a prospective study undertaken to highlight the possible relationship between LRI in early life and trigger of atopy and asthma in 3 year-old… Read more about this study
- Who is it for?
- Ages 3 to 32 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- body plethysmography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2004to Jun 2007
- 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 3 to 32 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child under 32 months old
- child suffering from bronchiolitis episode at least 3 weeks before beginning the study
Who cannot join
- child over 32 months old
- child suffering from bronchiolitis episode since less than 3 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow up of Ventilatory Function in Infant After One (or More) Bronchiolitis During the First Year of Life. Course Towards Asthma
A significant proportion of asthma is diagnosed during childhood. Bronchiolitis is the most common lower respiratory tract illness (LRI) in early life and the present work is a prospective study undertaken to highlight the possible relationship between LRI in early life and trigger of atopy and asthma in 3 year-old childhood, using paediatric lung function testing.
Twenty nine infants (8 females and 21 males) were included in our study. The beginning of the study started at least three weeks after the first bronchiolitis episode. Pulmonary function test was realized using an infant specific body plethysmography (Babybody, Erich Jaeger, Germany). Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using oscillometry and occlusion systems (Masterlab-IOS, Erich Jaeger, Germany). If measured data showed an obstruction, a bronchodilatator was inhaled to assess reversibility. When results were normal, a bronchial provocation test, using inhaled metacholine, was performed.
Read more
Skin prick tests (SPTs) were performed during the first exam, and at 24 and 36 months (Stallergenes-DHS).
Collection of data was largely incomplete due to a number of patients lost of follow up. Based on the available data, it can be conclude that most of lung tests results were in the normal range but a non negligible bronchial hyper reactivity was documented (41% of patients).
This study must be continued to increase the number of included patients and to continue their follow up during a longer time.
Read the detailed description
Asthma affects a large population throughout the world and about two millions of persons in France, killing two hundred patients by year. A significant proportion of cases of asthma are diagnosed during childhood. Understanding the relation between early-life infectious exposures and asthma and atopy appears to be considerable interest.
Respiratory infectious illnesses, mostly viral, are very common in childhood. Bronchiolitis is the most common lower respiratory tract illness (LRI) in early life (1). It is commonly caused by respiratory syncytial virus (RSV) and is often associated with subsequent wheezing and childhood asthma (2). Respiratory infectious illnesses caused by other agent than RSV can be also associated with asthma and atopy (3). However, the relation between respiratory infectious illnesses in early life and asthma in childhood is again much debated since some studies show a relationship between bronchiolitis and atopy (4) but not others (5, 6).
The present work is a prospective study undertaken to highlight the possible relationship between LRI in early life and trigger of atopy and asthma in 3 year-old childhood, using paediatric lung function testing.
Twenty nine infants (8 females and 21 males) were included in our study and 8 of 29 infants were of premature birth. The youngest patient was 3 months old and the older fourteen months old. The beginning of the study started at least three weeks after the first bronchiolitis episode. Pulmonary function test was realized using body plethysmography (Babybody, Erich Jaeger, Germany). Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using an oscillometry system and an occlusion system (Masterlab-IOS, Erich Jaeger, Germany). All respiratory tests were performed on patients in asymptomatic respiratory condition and at least one month apart from respiratory infection. If measured data showed an obstruction, a bronchodilator was inhaled to assess reversibility. When results were normal, a bronchial provocation test, using inhaled metacholine, was performed.
Skin prick tests (SPTs) were performed at the first exam, and at 24 and 36 months (Stallergenes-DHS). Dermatophagoides pteronyssinus, alternaria, cat dander, cockroach, orchard grass and timothy grass were systematically tested. The SPTs were considered positive when the wheal diameter was over 3 mm and 50% larger than the positive control, and the negative control remained negative (7). The possibility of dermographism was eliminated by a negative reaction of the negative control.
Collection of data was largely incomplete due to a number of patients lost of follow up. Briefly, based on the available data, most of lung tests results were in the normal range although a proportion of patients experienced recurrent wheezing episodes during follow up. Nevertheless a bronchial hyper reactivity to metacholine was documented in 41%. Atopy, as screened by SPTs, was detected in a minority of infants (13.5%). Coexistence of bronchial hyper reactivity and atopy was present in only one patient.
These incomplete results highlight the complex interplay between symptoms, bronchial obstruction, bronchial hyper reactivity and atopy in the subsequent development of asthma in wheezy children. Long term follow up is necessary to assess the prognostic value of these parameters.
- Conditions
- Bronchiolitis
- Being tested
- body plethysmography
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body plethysmographyProcedure or surgery
Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using an oscillometry system and an occlusion system
| Study group | Role | What they receive |
|---|---|---|
| A | Other | body plethysmography Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using an oscillometry system and an occlusion system Receives: Procedure: body plethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body plethysmography at least three weeks after the first bronchiolitis episode and at 18 and 24 months
Measured: 18, 24, 30 and 36 months
Respiratory resistances measure (oscillometry and occlusion systems) at 30 and 36 months
Measured: 18, 24, 30 and 36 months
Secondary outcomes (1)
Skin prick tests
Measured: at the first exam, and at 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startJan 2004
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique CRENESSE, PU PH, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676351
- Sponsor's protocol ID
- 02-PHRC-05
- Status last verified
- Mar 2026
- First submitted
- 12 May 2008
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Wright AL, Taussig LM, Ray CG, Harrison HR, Holberg CJ. The Tucson Children's Respiratory Study. II. Lower respiratory tract illness in the first year of life. Am J Epidemiol. 1989 Jun;129(6):1232-46. doi: 10.1093/oxfordjournals.aje.a115243.
PubMed 2729259Sigurs N, Gustafsson PM, Bjarnason R, Lundberg F, Schmidt S, Sigurbergsson F, Kjellman B. Severe respiratory syncytial virus bronchiolitis in infancy and asthma and allergy at age 13. Am J Respir Crit Care Med. 2005 Jan 15;171(2):137-41. doi: 10.1164/rccm.200406-730OC. Epub 2004 Oct 29.
PubMed 15516534Van Bever HP, Wieringa MH, Weyler JJ, Nelen VJ, Fortuin M, Vermeire PA. Croup and recurrent croup: their association with asthma and allergy. An epidemiological study on 5-8-year-old children. Eur J Pediatr. 1999 Mar;158(3):253-7. doi: 10.1007/s004310051062.
PubMed 10094451Schauer U, Hoffjan S, Bittscheidt J, Kochling A, Hemmis S, Bongartz S, Stephan V. RSV bronchiolitis and risk of wheeze and allergic sensitisation in the first year of life. Eur Respir J. 2002 Nov;20(5):1277-83. doi: 10.1183/09031936.02.00019902.
PubMed 12449185Stein RT, Sherrill D, Morgan WJ, Holberg CJ, Halonen M, Taussig LM, Wright AL, Martinez FD. Respiratory syncytial virus in early life and risk of wheeze and allergy by age 13 years. Lancet. 1999 Aug 14;354(9178):541-5. doi: 10.1016/S0140-6736(98)10321-5.
PubMed 10470697Sampson HA, Albergo R. Comparison of results of skin tests, RAST, and double-blind, placebo-controlled food challenges in children with atopic dermatitis. J Allergy Clin Immunol. 1984 Jul;74(1):26-33. doi: 10.1016/0091-6749(84)90083-6.
PubMed 6547461Capasso G, Jaeger P, Robertson WG, Unwin RJ. Uric acid and the kidney: urate transport, stone disease and progressive renal failure. Curr Pharm Des. 2005;11(32):4153-9. doi: 10.2174/138161205774913219.
PubMed 16375737
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up of Ventilatory Function in Infant After One (or More) Bronchiolitis During the First Year of Life. Course Towards Asthma
- ClinicalTrials.gov ID
- NCT00676351
- Acronym / sponsor ID
- 02-PHRC-05
- Conditions
- Bronchiolitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 13 May 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.
A significant proportion of asthma is diagnosed during childhood. Bronchiolitis is the most common lower respiratory tract illness (LRI) in early life and the present work is a prospective study undertaken to highlight the possible relationship between LRI in early life and trigger of atopy and asthma in 3 year-old childhood, using paediatric lung function testing.
Twenty nine infants (8 females and 21 males) were included in our study. The beginning of the study started at least three weeks after the first bronchiolitis episode. Pulmonary function test was realized using an infant specific body plethysmography (Babybody, Erich Jaeger, Germany). Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using oscillometry and occlusion systems (Masterlab-IOS, Erich Jaeger, Germany). If measured data showed an obstruction, a bronchodilatator was inhaled to assess reversibility. When results were normal, a bronchial provocation test, using inhaled metacholine, was performed.
Skin prick tests (SPTs) were performed during the first exam, and at 24 and 36 months (Stallergenes-DHS).
Collection of data was largely incomplete due to a number of patients lost of follow up. Based on the available data, it can be conclude that most of lung tests results were in the normal range but a non negligible bronchial hyper reactivity was documented (41% of patients).
This study must be continued to increase the number of included patients and to continue their follow up during a longer time.
Detailed description
Asthma affects a large population throughout the world and about two millions of persons in France, killing two hundred patients by year. A significant proportion of cases of asthma are diagnosed during childhood. Understanding the relation between early-life infectious exposures and asthma and atopy appears to be considerable interest.
Respiratory infectious illnesses, mostly viral, are very common in childhood. Bronchiolitis is the most common lower respiratory tract illness (LRI) in early life (1). It is commonly caused by respiratory syncytial virus (RSV) and is often associated with subsequent wheezing and childhood asthma (2). Respiratory infectious illnesses caused by other agent than RSV can be also associated with asthma and atopy (3). However, the relation between respiratory infectious illnesses in early life and asthma in childhood is again much debated since some studies show a relationship between bronchiolitis and atopy (4) but not others (5, 6).
The present work is a prospective study undertaken to highlight the possible relationship between LRI in early life and trigger of atopy and asthma in 3 year-old childhood, using paediatric lung function testing.
Twenty nine infants (8 females and 21 males) were included in our study and 8 of 29 infants were of premature birth. The youngest patient was 3 months old and the older fourteen months old. The beginning of the study started at least three weeks after the first bronchiolitis episode. Pulmonary function test was realized using body plethysmography (Babybody, Erich Jaeger, Germany). Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using an oscillometry system and an occlusion system (Masterlab-IOS, Erich Jaeger, Germany). All respiratory tests were performed on patients in asymptomatic respiratory condition and at least one month apart from respiratory infection. If measured data showed an obstruction, a bronchodilator was inhaled to assess reversibility. When results were normal, a bronchial provocation test, using inhaled metacholine, was performed.
Skin prick tests (SPTs) were performed at the first exam, and at 24 and 36 months (Stallergenes-DHS). Dermatophagoides pteronyssinus, alternaria, cat dander, cockroach, orchard grass and timothy grass were systematically tested. The SPTs were considered positive when the wheal diameter was over 3 mm and 50% larger than the positive control, and the negative control remained negative (7). The possibility of dermographism was eliminated by a negative reaction of the negative control.
Collection of data was largely incomplete due to a number of patients lost of follow up. Briefly, based on the available data, most of lung tests results were in the normal range although a proportion of patients experienced recurrent wheezing episodes during follow up. Nevertheless a bronchial hyper reactivity to metacholine was documented in 41%. Atopy, as screened by SPTs, was detected in a minority of infants (13.5%). Coexistence of bronchial hyper reactivity and atopy was present in only one patient.
These incomplete results highlight the complex interplay between symptoms, bronchial obstruction, bronchial hyper reactivity and atopy in the subsequent development of asthma in wheezy children. Long term follow up is necessary to assess the prognostic value of these parameters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Procedure: body plethysmographybody plethysmography Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using an oscillometry system and an occlusion system |
Who may qualify
- Ages
- 3 to 32 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- child under 32 months old
- child suffering from bronchiolitis episode at least 3 weeks before beginning the study
Key exclusion criteria (2 listed)
- child over 32 months old
- child suffering from bronchiolitis episode since less than 3 weeks
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 |
|---|---|---|
| body plethysmographySame tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using an oscillometry system and an occlusion system | Procedure or surgery | A |
Primary outcome
Body plethysmography at least three weeks after the first bronchiolitis episode and at 18 and 24 months
Time frame: 18, 24, 30 and 36 months
Respiratory resistances measure (oscillometry and occlusion systems) at 30 and 36 months
Time frame: 18, 24, 30 and 36 months
1 secondary outcome
Skin prick tests
Time frame: at the first exam, and at 24 and 36 months
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 31 Mar 2026.
- Background: PubMed 2729259Wright AL, Taussig LM, Ray CG, Harrison HR, Holberg CJ. The Tucson Children's Respiratory Study. II. Lower respiratory tract illness in the first year of life. Am J Epidemiol. 1989 Jun;129(6):1232-46. doi: 10.1093/oxfordjournals.aje.a115243.
- Background: PubMed 15516534Sigurs N, Gustafsson PM, Bjarnason R, Lundberg F, Schmidt S, Sigurbergsson F, Kjellman B. Severe respiratory syncytial virus bronchiolitis in infancy and asthma and allergy at age 13. Am J Respir Crit Care Med. 2005 Jan 15;171(2):137-41. doi: 10.1164/rccm.200406-730OC. Epub 2004 Oct 29.
- Background: PubMed 10094451Van Bever HP, Wieringa MH, Weyler JJ, Nelen VJ, Fortuin M, Vermeire PA. Croup and recurrent croup: their association with asthma and allergy. An epidemiological study on 5-8-year-old children. Eur J Pediatr. 1999 Mar;158(3):253-7. doi: 10.1007/s004310051062.
- Background: PubMed 12449185Schauer U, Hoffjan S, Bittscheidt J, Kochling A, Hemmis S, Bongartz S, Stephan V. RSV bronchiolitis and risk of wheeze and allergic sensitisation in the first year of life. Eur Respir J. 2002 Nov;20(5):1277-83. doi: 10.1183/09031936.02.00019902.
- Background: PubMed 10470697Stein RT, Sherrill D, Morgan WJ, Holberg CJ, Halonen M, Taussig LM, Wright AL, Martinez FD. Respiratory syncytial virus in early life and risk of wheeze and allergy by age 13 years. Lancet. 1999 Aug 14;354(9178):541-5. doi: 10.1016/S0140-6736(98)10321-5.
- Background: PubMed 6547461Sampson HA, Albergo R. Comparison of results of skin tests, RAST, and double-blind, placebo-controlled food challenges in children with atopic dermatitis. J Allergy Clin Immunol. 1984 Jul;74(1):26-33. doi: 10.1016/0091-6749(84)90083-6.
- Results publication: PubMed 16375737Capasso G, Jaeger P, Robertson WG, Unwin RJ. Uric acid and the kidney: urate transport, stone disease and progressive renal failure. Curr Pharm Des. 2005;11(32):4153-9. doi: 10.2174/138161205774913219.
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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.
Dominique CRENESSE, PU PH principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing body plethysmography in people with Bronchiolitis, run by Centre Hospitalier Universitaire de Nice 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 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: finished, as of the sponsor's last update on 31 Mar 2026. 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?
Body plethysmography at least three weeks after the first bronchiolitis episode and at 18 and 24 months (time frame: 18, 24, 30 and 36 months). The study lists 2 primary outcomes in all. 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 NCT00676351, which also lists 7 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 31 Mar 2026.