Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma
This study has been completed.
Sponsor:
Novartis
Collaborator:
Genentech
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00482248
First received: June 4, 2007
Last updated: October 24, 2011
Last verified: October 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study will assess further the safety and tolerability of long-term treatment with omalizumab by extending omalizumab treatment by 1 year for those patients with allergic asthma who successfully completed study CIGE25011E2.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Omalizumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Extension Study to Assess Long Term Safety and Tolerability of Omalizumab Treatment in Adults and Adolescents With Severe Allergic Asthma Who Participated in the 52 Week CIGE250011E2 Study |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Safety assessed by adverse events, serious adverse events, hematology, blood chemistry and urinalysis value, vital signs data, the performance of physical examinations and body weight measurements.
Secondary Outcome Measures:
- Efficacy assessed by changes in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC), the investigator's assessment of asthma control, corticosteroid use, the incidence of hospitalization and outpatients visits, and absenteeism fr
| Enrollment: | 132 |
| Study Start Date: | June 2003 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 12 Years to 75 Years |
| Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
- Patients with a history of severe allergic asthma who completed the treatment period of CIGE250011E3 protocol, without experiencing any significant drug-related adverse events
- Male or female patients 12-75 years of age who have given written informed consent approved by the ethical committee
Exclusion Criteria:
- Patients who had not received study medication for greater than 84 days since visit 38 of study CIGE240011E3
- Pregnant females or nursing mothers
- Patients with know hypersensitivity to any ingredients of Omalizumab or related drugs
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00482248 History of Changes |
| Other Study ID Numbers: | CIGE0250011E3 |
| Study First Received: | June 4, 2007 |
| Last Updated: | October 24, 2011 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Germany: Federal Institute for Drugs and Medical Devices France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Canada: Health Canada Italy: Direzione Generale di Sanità Veterinaria e degli Alimenti Russia: Ministry of Public Health Sweden: Medical Products Agency Netherlands: Medicines Evaluation Board (MEB) Czech Republic: State Institute for Drug Control United Kingdom: Medical and Healthcare Products Regulatory Agency (MHRA) |
Keywords provided by Novartis:
|
Asthma anti-immunoglobulin E omalizumab allergic asthma |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity |
Immune System Diseases Omalizumab Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 21, 2013