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NCT00267202 · ClinicalTrials.gov registry record · Phase 4
Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherapy in Patients With Persistent Allergic Asthma
A Phase 4 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 4
- Development phase
- 275
- Enrollment target
NCT00267202: Completed Phase 4 study, sponsored by Novartis.
NCT00267202 is a Phase 4 study that has completed, run by Novartis. The registered enrollment target is 275 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00267202, a Phase 4 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 275 participants
- Enrollment target
Study Summary
This study is designed to investigate the use of omalizumab as a pretreatment for patients with persistent allergic asthma who are candidates for allergen immunotherapy (ie, allergy shots) and will test the hypothesis that omalizumab may reduce the rate of systemic reactions to immunotherapy in patients with persistent allergic asthma.
Primary Outcome
The number of participants with Systemic Allergic Reactions (SAR) to Specific Immunotherapy (SIT). A SAR was captured and recorded as an outcome, not as adverse events (AEs) or SAEs. The primary analysis time point was the end of Period 4 (maintenance immunotherapy). Participants were observed for 1 hour after each immunotherapy (IT) injection visit. Allergic reactions were graded on a 4-point scale from Grade 1 to Grade 4. Grade 1: Skin symptoms, Grade 2: Gastrointestinal symptoms, Grade 3: Res
Interventions
- DRUG Placebo
- DRUG Immunotherapy
- DRUG Omalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2005-12 |
| Est. Completion | 2008-04 |
| Phase | Phase 4 |
What the finished NCT00267202 record still lists
NCT00267202 is an interventional study that assigns participants to a tested intervention. The registered 275 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00267202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00267202 about?
NCT00267202 is a clinical study titled "Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherapy in Patients With Persistent Allergic Asthma". This study is designed to investigate the use of omalizumab as a pretreatment for patients with persistent allergic asthma who are candidates for allergen immunotherapy (ie, allergy shots) and will test the hypothesis that omalizumab may reduce the rate of systemic reactions to immunotherapy in pati...
What is the current status of trial NCT00267202?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 275 participants. The study started on 2005-12. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00267202?
The interventions under investigation include: Placebo (DRUG), Immunotherapy (DRUG), Omalizumab (DRUG).
Who is sponsoring clinical trial NCT00267202?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00267202's enrollment target sits among peer trials
275 311th of 2000 higher than 1,689 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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