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Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma

NCT01007149 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2012-07-20

Study results available
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Summary

This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.

Conditions

Interventions

DRUG

omalizumab

Omalizumab was supplied in 5mL vials with solution for subcutaneous injection.

DRUG

Placebo

Placebo was supplied in vials with solution for subcutaneous injection.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • France

Study Locations

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Entities

Drugs
Diseases
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 NCT01007149 on ClinicalTrials.gov