An Observational Follow-Up Study of Pediatric Patients Who Participated in a Previous Respiratory Syncytial Virus (RSV)-Induced Bronchiolitis Study of Montelukast

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003971-38-FR

Enrollment

400

Registered

2007-10-01

Start date

2007-10-03

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma and atopic diseases MedDRA version: 9.1 Level: LLT Classification code 10003560 Term: Asthma NOS MedDRA version: 9.1 Level: LLT Classification code 10003637 Term: Atopic

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient successfully completed Visit 8 of Protocol 272. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient has developed or has been diagnosed with any illness or congenital disorder that could be immediately life threatening (e.g., arrhythmias congenital heart disease, “brittle diabetes,” neoplasia incompletely cured or treated within the last 3 months), or would pose a restriction on participation or successful completion of the study.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Outcome measurements: Diagnosis of Asthma, Diagnosis of Atopic Disorders3, and Use of Chronic Asthma Therapy based on standardized Epidemiology Questionnaire. ; Main Objective: Objective 1: To evaluate the relationships between baseline characteristics (e.g., family history, demographics, characteristics of the study episode [Protocol 272] of acute RSV-induced bronchiolitis) and the outcomes of Asthma, Atopic Disorders, and Use of Chronic Asthma Therapy at 6 years of age. ; Secondary Objective: Objective 2: To explore the relationships between biomarkers (e.g., eotaxin, IgE, IL-13, TNF-a and the outcomes of Asthma and Atopic Disorders at 6 years of age. Objective 3: To estimate the impact of Protocol 272 montelukast treatment on the diagnosis of Asthma and Atopic Disorders, and use of Chronic Asthma Therapy at 6 years of age. Objective 4: To estimate the impact of Protocol 272 montelukast treatment on the diagnosis of Asthma and Atopic Disorders, and use of Chronic Asthma Therapy at 6 years of age in the subgroup of patients with persistent symptoms2 and in the subgroup of patients without persistent symptoms. Objective 5: To estimate the Percentage of Patients with Asthma and Percentage of Patients with Atopic Disorders1 in the Protocol 272 placebo treatment group at 6 years of age, as well as in appropriate external pediatric cohorts.	—

Measure

Time frame

Primary end point(s): Outcome measurements: Diagnosis of Asthma, Diagnosis of Atopic Disorders3, and Use of Chronic Asthma Therapy based on standardized Epidemiology Questionnaire. ; Main Objective: Objective 1: To evaluate the relationships between baseline characteristics (e.g., family history, demographics, characteristics of the study episode [Protocol 272] of acute RSV-induced bronchiolitis) and the outcomes of Asthma, Atopic Disorders, and Use of Chronic Asthma Therapy at 6 years of age. ; Secondary Objective: Objective 2: To explore the relationships between biomarkers (e.g., eotaxin, IgE, IL-13, TNF-a and the outcomes of Asthma and Atopic Disorders at 6 years of age. Objective 3: To estimate the impact of Protocol 272 montelukast treatment on the diagnosis of Asthma and Atopic Disorders, and use of Chronic Asthma Therapy at 6 years of age. Objective 4: To estimate the impact of Protocol 272 montelukast treatment on the diagnosis of Asthma and Atopic Disorders, and use of Chronic Asthma Therapy at 6 years of age in the subgroup of patients with persistent symptoms2 and in the subgroup of patients without persistent symptoms. Objective 5: To estimate the Percentage of Patients with Asthma and Percentage of Patients with Atopic Disorders1 in the Protocol 272 placebo treatment group at 6 years of age, as well as in appropriate external pediatric cohorts.

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Countries

France, Germany, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026