Trial intelligence / Profile preview

Omalizumab in inner-city children with asthma

NCT00377572Phase 4

Key facts

Status: Completed
Start: Oct 2006
Primary completion: Dec 2009
Countries: 1
Sponsor: National Institute of Allergy and Infectious Diseases
Modality: Monoclonal Antibodies

Drugs: omalizumab
Conditions: asthma

Overview

Phase 4, randomised, double-blind trial in asthma comparing Omalizumab + Conventional Therapy with Placebo + Conventional Therapy (2 arms). Primary endpoint: Maximum Number of Asthma Symptom Days. Started Oct 2006; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Omalizumab + Conventional Therapy
Omalizumab injections + Standard of Care
Placebo + Conventional Therapy
Placebo injections + Standard of Care

Who it enrols

Inner-city children and adolescents (6-20 years) with moderate to severe allergic asthma, positive skin test to perennial allergen, and suitable IgE/weight for dosing.

Endpoints

Primary

Maximum Number of Asthma Symptom DaysWeeks 12-60

Secondary

Number of Missed School Days Due to AsthmaWeeks 12-60
Number of Missed Work Days by Caretaker Due to AsthmaWeeks 12-60
Child Asthma Control Test ScoreWeeks 12-60
Asthma Control Test ScoreWeeks 12-60
Forced Expiratory Volume in 1 Second % PredictedWeeks 12-60
FEV1/FVC RatioWeeks 12-60
Exhaled Nitric OxideWeeks 12-60
Percent Adherence to Asthma MedicationWeeks 12-60

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