CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 271 enrolled
Drug / intervention
Omalizumab +1 moredrug
Likely dose
Omalizumab 5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00870584
NCT00870584Phase 4Completed
CompareCT.gov

A 26-week Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma

Novartis Pharmaceuticals·interventional·Posted Mar 27, 2009·Updated Nov 17, 2011

In Brief

A Phase 4 clinical trial evaluating Omalizumab and Placebo for Persistent Allergic Asthma. Completed, enrolled 271 participants across 50 sites.

Detailed Summary

This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPersistent Allergic Asthma
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 27, 2009
Enrollment StartMar 1, 2009
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.3 years ago

Interventions

Omalizumabdrug

Omalizumab was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of omalizumab for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.

Placebodrug

Placebo was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of placebo for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.