At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 79 enrolled
Drug / intervention
omalizumab +1 moredrug
Likely dose
omalizumab 5mLfrom 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.
A 16-week Treatment, Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel-group Study to Assess the Effect of Omalizumab on the Expression of FcεRI Receptors of Blood Basophils and Dendritic Cells in Patients With Severe Persistent Non-atopic Asthma, Uncontrolled Despite Optimal Therapy
In Brief
A Phase 3 clinical trial evaluating omalizumab and Placebo for Asthma. Completed, enrolled 79 participants across 10 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesFrance
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedNov 2009
Primary CompletionFeb 2011
TodayJul 2026
First PostedNov 3, 2009
Enrollment StartSep 1, 2009
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.7 years ago
Interventions
omalizumabdrug
Omalizumab was supplied in 5mL vials with solution for subcutaneous injection.
Placebodrug
Placebo was supplied in vials with solution for subcutaneous injection.