NCT00676351

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

3.4 years

First QC Date

May 12, 2008

Last Update Submit

March 26, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Body plethysmography at least three weeks after the first bronchiolitis episode and at 18 and 24 months

    18, 24, 30 and 36 months

  • Respiratory resistances measure (oscillometry and occlusion systems) at 30 and 36 months

    18, 24, 30 and 36 months

Secondary Outcomes (1)

  • Skin prick tests

    at the first exam, and at 24 and 36 months

Study Arms (1)

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

Procedure: body plethysmography

Interventions

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

A

Eligibility Criteria

Age3 Months - 32 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • child under 32 months old
  • child suffering from bronchiolitis episode at least 3 weeks before beginning the study

You may not qualify if:

  • child over 32 months old
  • child suffering from bronchiolitis episode since less than 3 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRENESSE Dominique

Nice, 06000, France

Location

Related Publications (7)

  • 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.

    PMID: 2729259BACKGROUND
  • Sigurs 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.

    PMID: 15516534BACKGROUND
  • Van 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.

    PMID: 10094451BACKGROUND
  • Schauer 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.

    PMID: 12449185BACKGROUND
  • Stein 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.

    PMID: 10470697BACKGROUND
  • Sampson 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.

    PMID: 6547461BACKGROUND
  • Capasso 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.

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Dominique CRENESSE, PU PH

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2008

First Posted

May 13, 2008

Study Start

January 1, 2004

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations