Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00078195 · ClinicalTrials.gov registry record · Phase 2
Omalizumab (Xolair) and Allergy Shots For the Treatment of Seasonal Allergies
A Phase 2 study of Allergy and Hypersensitivity, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
- 3
- Study locations
NCT00078195: Completed Phase 2 study of Allergy and Hypersensitivity, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00078195 is a Phase 2 study of Allergy and Hypersensitivity that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 168 participants, below the 321-participant average among 15 other Allergy trials with a reported enrollment target (48% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00078195, a Phase 2 study of Allergy and Hypersensitivity, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
- 3
- Study locations
Study Summary
A series of allergy shots may reduce symptoms of seasonal ragweed allergies. This study will determine whether taking a drug called omalizumab (also known as Xolair) before getting the allergy shots is more effective than allergy shots alone or other treatments, such as prescription antihistamines.
Primary Outcome
The average daily allergy severity score will be calculated from participants' 5 symptom scores (sneezing; rhinorrhea/runny nose; itchy nose, throat, and palate; itchy, watery eyes; and nasal congestion/stuffiness) during the ragweed pollen season. Symptom scores are recorded twice daily (AM and PM). The sum of the individual symptom scores will be averaged over AM and PM to give a daily score. Each daily score will then be averaged to obtain one measure of the average daily allergy severity sco
Conditions Studied
Interventions
- BIOLOGICAL omalizumab
- BIOLOGICAL Placebo omalizumab
- BIOLOGICAL Ragweed rush immunotherapy (RIT)
- BIOLOGICAL Placebo rush immunotherapy (RIT)
- BIOLOGICAL Ragweed immunotherapy (IT)
Study Locations (3)
Iowa
- University of Iowa - Iowa City
Nebraska
- Creighton University - Omaha
Wisconsin
- University of Wisconsin - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2003-04 |
| Est. Completion | 2005-05 |
| Phase | Phase 2 |
What the finished NCT00078195 record still lists
NCT00078195 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 321-participant average among 15 other Allergy trials with a reported enrollment target (48% lower).
The record links to 4 conditions, with Allergy appearing as the primary indexed condition, and to 5 interventions - of which omalizumab is the first listed.
NCT00078195 reports a single indexed study location in Iowa, Nebraska, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT00078195 about?
NCT00078195 is a clinical study titled "Omalizumab (Xolair) and Allergy Shots For the Treatment of Seasonal Allergies". A series of allergy shots may reduce symptoms of seasonal ragweed allergies. This study will determine whether taking a drug called omalizumab (also known as Xolair) before getting the allergy shots is more effective than allergy shots alone or other treatments, such as prescription antihistamines.
What is the current status of trial NCT00078195?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2003-04. Estimated completion is 2005-05.
What conditions does trial NCT00078195 study?
This clinical trial studies the following conditions: Allergy, Hypersensitivity, Hay Fever, Rhinitis.
What interventions are being tested in trial NCT00078195?
The interventions under investigation include: omalizumab (BIOLOGICAL), Placebo omalizumab (BIOLOGICAL), Ragweed rush immunotherapy (RIT) (BIOLOGICAL), Placebo rush immunotherapy (RIT) (BIOLOGICAL), Ragweed immunotherapy (IT) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00078195?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00078195 being conducted?
This trial has 3 study locations across Iowa, Nebraska, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Allergy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00078195's enrollment target sits among peer trials
168 7th of 15 higher than 9 of 15 other Allergy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Allergy 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
-
Understanding Allergies and Sensitizations in Healthy and Allergic Individuals
RECRUITING
-
The Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron
RECRUITING · Phase 4
-
Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
RECRUITING · Phase 3
-
Childhood Allergy and the Neonatal Environment
ACTIVE NOT RECRUITING
-
Urban Environmental Factors and Childhood Asthma
COMPLETED
-
Vitamin D, Steroids, and Asthma in African American Youth
COMPLETED
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02118922 · 168 participants
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
- NCT03536897 · 168 participants
IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
- NCT04078230 · 168 participants · NA
Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma
- NCT04159168 · 168 participants · NA
Facial Affect Sensitivity Training for Young Children With Callous-unemotional Traits
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia