Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03915197
Other study ID # CHU-433
Secondary ID 2018-A02659-46
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2, 2019
Est. completion date October 30, 2023

Study information

Verified date April 2019
Source University Hospital, Clermont-Ferrand
Contact Lise LACLAUTRE
Phone 0473754963
Email promo_interne_drci@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Predicting the risk of allergenic sensitizations and asthma development in the first year of life is difficult.

Investigator decided to follow prospectively two cohorts of infants with acute bronchiolitis, hospitalized or treated at home, from the epidemic seasons of 2011-2012 and 2015-2017 to know their respiratory evolution, especially if they developed allergen sensitization and / or asthma.


Description:

Follow-up consultation 6 years after an episode of acute bronchiolitis at Clermont-Ferrand hospital with:

- Consultation with a pneumopediatrician: collection of respiratory symptoms, respiratory treatments, evaluation of the atopic site and environmental risk factors for bronchial aggression, especially passive smoking;

- Physical examination ;

- Evaluation of precariousness during the same interview with the EPICES questionnaire;

- Prick tests with positive control (histamine) and negative (physiological saline) and prick for the main pneumallergens (mites, alternaria, grasses, cat and dog) and trophallergens (egg, milk, fish, soy, wheat, peanut);

- Blood test with blood count, determination of specific IgE (5 pneumallergens and 5 trophallergens), dosage of sRAGE;

- Fonctionnal respiratory test with reversibility test


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 320
Est. completion date October 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 7 Years to 9 Years
Eligibility Inclusion Criteria:

- Acute bronchiolitis in an infant less than one year old, included in studies KL6 (winter period 2011-2012) or CC16 (winter period 2015-2016) at clermont-ferrand hospital.

Exclusion Criteria:

- Bronchopulmonary dysplasia;

- History of prematurity <34 AS;

- Mucoviscidosis;

- known immune deficiencies;

- Primary ciliary dyskinesia suspected;

- Congenital heart disease;

- Acute renal failure.

- Refusal of parents to participate

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Pneumological evaluation
Consultation with a pneumopediatrician: collection of respiratory symptoms, respiratory treatments, evaluation of the atopic site and environmental risk factors for bronchial aggression, especially passive smoking

Locations

Country Name City State
France Chu Clermont-Ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Risk factors for asthma 6 years after an episode of acute bronchiolitis Presence / absence of asthma 6-9 years after an episode of bronchiolitis during the first year of life
The diagnosis of asthma is established during a consultation by a pneumopediatrician on the following criteria:
=3 documented respiratory symptoms = 2 times;
Or an episode lasting = 4 weeks;
With symptoms: tachypnea, wheezing, expiratory stridor, signs of chest retraction or wheezing diagnosed by a doctor.
at 6 years
Secondary Correlation between onset of asthma and severity of bronchiolitis Severity of acute bronchiolitis, assessed by a clinical score based on control signs, spO2 and respiratory rate (Wainwright score) and the length of hospital stay at 6 years
Secondary relationship between KL-6 serum markers and the occurrence of longer-term asthma Correlation between onset of asthma and concentration of KL-6 during bronchiolitis at 6 years
Secondary relationship between CC16 serum markers and the occurrence of longer-term asthma Correlation between onset of asthma and concentration of CC16 during bronchiolitis. at 6 years
Secondary relationship between sRAGE serum markers and the occurrence of longer-term asthma Correlation between onset of asthma and concentration of sRAGE during bronchiolitis at 6 years
See also
  Status Clinical Trial Phase
Completed NCT04624425 - Additional Effects of Segmental Breathing In Asthma N/A
Terminated NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma Phase 2
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT03694158 - Investigating Dupilumab's Effect in Asthma by Genotype Phase 4
Terminated NCT04946318 - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma Phase 2
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Completed NCT03086460 - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH) Phase 2
Completed NCT01160224 - Oral GW766944 (Oral CCR3 Antagonist) Phase 2
Completed NCT03186209 - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) Phase 3
Completed NCT02502734 - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma Phase 3
Completed NCT01715844 - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics Phase 1
Terminated NCT04993443 - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Phase 1
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT06033833 - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Phase 2
Completed NCT03257995 - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. Phase 2
Completed NCT02212483 - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT01468805 - Childhood Asthma Reduction Study N/A
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device