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Omalizumab in Non-atopic Asthma

NCT01113437 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-01-21

No results posted yet for this study

Summary

Hypothesis- Omalizumab(humanized monoclonal anti-IgE antibody)improves disease control and reduces bronchial mucosal inflammation in non-atopic asthma.

In order to test the above hypothesis, the investigators propose a placebo controlled, double blind, parallel group study to obtain proof of principle that omalizumab exerts beneficial effects on disease control in non-atopic severe adult asthmatics aged 18-60 years . Forty patients will be randomized in a 1:1 ratio to receive omalizumab or matching placebo. Following 12 weeks of treatment with omalizumab/placebo, and as this treatment is continued for a further 8 weeks, anti-asthma treatment will be reduced. Dosages will be administered at 4 or 2 weekly intervals over a 16 week period (5 or 10 doses in total), which corresponds with the time stated as necessary to judge efficacy of therapy according to omalizumab's licensed indications in atopic asthma. Efficacy will be judged by clinical monitoring and by bronchial biopsy to assess effects on bronchial inflammation and local IgE production.

Conditions

  • Bronchial Asthma

Interventions

DRUG

Omalizumab

Omalizumab or placebo by subcutaneous injections, at 4 weekly or 2 weekly intervals. Dosage is according to manufacturer's guidance and calculated based on body weight and total serum IgE.

DRUG

Placebo

Omalizumab or placebo by subcutaneous injections, at 4 weekly or 2 weekly intervals. Dosage is according to manufacturer's guidance and calculated based on body weight and total serum IgE.

Sponsors & Collaborators

Principal Investigators

  • Christopher Corrigan, MD, PhD · King's College, London, UK

  • Neil Barnes, MD · London Chest Hospital, UK

  • Prathap Pillai, MD · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-08-31

Countries

  • United Kingdom

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01113437 on ClinicalTrials.gov