# Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations

> **NCT01430403** · PHASE4 · COMPLETED · sponsor: **National Institute of Allergy and Infectious Diseases (NIAID)** · enrollment: 478 (actual)

## Conditions studied

- Asthma

## Interventions

- **BIOLOGICAL:** Omalizumab
- **DRUG:** Inhaled Corticosteroid Boost Therapy (ICS)
- **BIOLOGICAL:** Placebo omalizumab
- **BIOLOGICAL:** Placebo fluticasone

## Key facts

- **NCT ID:** NCT01430403
- **Lead sponsor:** National Institute of Allergy and Infectious Diseases (NIAID)
- **Sponsor class:** NIH
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-09
- **Primary completion:** 2013-12
- **Final completion:** 2014-03
- **Target enrollment:** 478 (ACTUAL)
- **Last updated:** 2017-05-30

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01430403

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01430403, "Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT01430403. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*