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NCT00670930 · ClinicalTrials.gov registry record · Phase 4

Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists

A Phase 4 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 4
Development phase
36
Enrollment target

NCT00670930 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 36 participants.

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The verdict

NCT00670930, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 4
Development phase
36 participants
Enrollment target

Study Summary

This study aims to investigate the effect of omalizumab on the number of tissue eosinophils and other markers of airway inflammation and remodeling, including thickness of the lamina reticularis, in moderate to severe asthmatics with persistent symptoms and evidence of airway inflammation despite treatment with inhaled corticosteroids and long acting beta-agonists. This study will also investigate the correlation between systemic and pulmonary inflammation, and the correlation between clinical outcomes and changes within the tissue, to assist in the future identification of patients with tissue eosinophilia and their response to treatment, without the need for invasive bronchoscopy.

Interventions

  • DRUG Placebo
  • DRUG omalizumab at a dose of 0.016mg/kg/IU/mL

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2008-04
Est. Completion 2011-11
Phase Phase 4

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT00670930

The ClinicalTrials.gov registry entry for NCT00670930 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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

NCT00670930 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00670930 about?

NCT00670930 is a clinical study titled "Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists". This study aims to investigate the effect of omalizumab on the number of tissue eosinophils and other markers of airway inflammation and remodeling, including thickness of the lamina reticularis, in moderate to severe asthmatics with persistent symptoms and evidence of airway inflammation despite tr...

What is the current status of trial NCT00670930?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2008-04. Estimated completion is 2011-11.

What interventions are being tested in trial NCT00670930?

The interventions under investigation include: Placebo (DRUG), omalizumab at a dose of 0.016mg/kg/IU/mL (DRUG).

Who is sponsoring clinical trial NCT00670930?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.