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NCT00377572 · ClinicalTrials.gov registry record · Phase 4

Inner-City Anti-IgE Therapy for Asthma

A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 4
Development phase
419
Enrollment target

NCT00377572: Completed Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00377572 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 419 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00377572, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 4
Development phase
419 participants
Enrollment target

Study Summary

The purpose of this study is to find out if adding omalizumab to standard asthma treatment results in a safer, more effective, and longer lasting asthma treatment strategy than standard treatment alone, in inner-city children with mild to severe asthma.

Primary Outcome

Maximum symptom days was calculated as the largest of the following variables: number of days with wheezing, chest tightness, or cough; number of nights of sleep disturbance; and number of days when activities were affected. This symptom scale ranges from 0 to 14 days per a 2-week look-back period. A higher score reflected a greater number of asthma symptoms. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment p

Interventions

  • BIOLOGICAL omalizumab
  • BIOLOGICAL omalizumab placebo

Trial Details

FieldValue
Enrollment Target 419 participants
Start Date 2006-10
Est. Completion 2009-12
Phase Phase 4

What the finished NCT00377572 record still lists

NCT00377572 is an interventional study that assigns participants to a tested intervention. The registered 419 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 (19% lower).

The record links to 0 conditions, and to 2 interventions - of which omalizumab is the first listed.

NCT00377572 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00377572 about?

NCT00377572 is a clinical study titled "Inner-City Anti-IgE Therapy for Asthma". The purpose of this study is to find out if adding omalizumab to standard asthma treatment results in a safer, more effective, and longer lasting asthma treatment strategy than standard treatment alone, in inner-city children with mild to severe asthma.

What is the current status of trial NCT00377572?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 419 participants. The study started on 2006-10. Estimated completion is 2009-12.

What interventions are being tested in trial NCT00377572?

The interventions under investigation include: omalizumab (BIOLOGICAL), omalizumab placebo (BIOLOGICAL).

Who is sponsoring clinical trial NCT00377572?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00377572's enrollment target sits among peer trials

419 202nd of 2000 higher than 1,799 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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Source: ClinicalTrials.gov NCT00377572, the US trial registry maintained by the National Library of Medicine. NCT00377572 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.