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DSIP

Emideltide, DSIP nonapeptide, Delta sleep-inducing peptide

Quick Stats
Studies 458
Trials 82
Completed PHASE4 INTERVENTIONAL NCT01430403

Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The purpose of this trial is to compare the efficacy of 4 to 5 months of three treatments - omalizumab, corticosteroid therapy boost, and placebo - in reducing fall exacerbations in inner-city children and adolescents with allergic persistent asthma when initiated approximately 4 -6 weeks prior to the start of the first day of each participant's school year.

Detailed Description

While the increase in the prevalence of asthma has abated, levels of asthma morbidity and mortality remain near record highs. An asthma exacerbation is a major factor contributing to morbidity, and even mortality in patients with asthma. Although current approaches to treatment have reduced these risks, asthma exacerbations are major problems for inner-city patients and their families, and prevention of these events continues to be a significant challenge. In children with asthma, there are predictable seasonal epidemics of exacerbations, especially during the fall season, otherwise known as the "September epidemic."

Interventions

Name: Omalizumab
Type: BIOLOGICAL
Description: Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) \[IU/mL\] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
Name: Inhaled Corticosteroid Boost Therapy (ICS)
Type: DRUG
Description: Self-administered fluticasone (Flovent Ā® DiskusĀ®) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone. All participants will receive standardized specialist asthma care.
Name: Placebo omalizumab
Type: BIOLOGICAL
Description: Placebo was administered subcutaneously every 2 or 4 weeks over a period of 4 to 5 months. Doses (mg) and dosing frequency were determined by serum total immunoglobulin E (IgE) level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP, 2007) guidelines, under the management of an asthma specialist health care provider.
Name: Placebo fluticasone
Type: BIOLOGICAL
Description: Self-administered placebo fluticasone (placebo Flovent Ā® DiskusĀ®) inhalers identical in dose and guidance as active fluticasone. All participants will receive standardized specialist asthma care.

Primary Outcomes

Measure: Occurrence of One or More Asthma Exacerbations (All Treatment Steps [Steps 2-5])
TimeFrame: 90 Day outcome period
Description: Asthma exacerbation defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≄ 20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≄10mg per day for ≄1 day. Odds ratio comparing Placebo and Omalizumab arms across all treatment steps (Steps 2-5).
Measure: Occurrence of One or More Asthma Exacerbations (Treatment Steps 2-4)
TimeFrame: 90 Day outcome period
Description: Asthma exacerbation defined as a prescription of a course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≄20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≄10mg per day for ≄1 day. Odds ratio comparing Inhaled corticosteroid boost therapy (ICS) and Omalizumab arms at Treatment Steps 2-4.

Trial Information

NCT ID

NCT01430403

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last Updated

December 15, 2025