Safety and Tolerability of Omalizumab in Poorly Controlled Moderate to Severe Asthma Patients
This study has been completed.
Sponsor:
Novartis
Collaborator:
Genentech
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00482508
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 the safety and tolerability of long-term treatment with omalizumab plus current asthma therapy in patients who participated in and successfully completed the treatment period of study CIGE025IA04E1. Patients who participated in CIGE025IA04E1 were perceived by both the patient and the investigator to have benefited from receiving treatment with omalizumab plus current asthma therapy according to best medical practice
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Omalizumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A One Year Open-label Extension Study to Assess Long Term Safety and Tolerability of Omalizumab Treatment in Poorly Controlled Moderate to Severe Allergic Asthma Patients Who Participated in the 52-week CIGE24IA04E1 Study |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Safety assessed by adverse events, serious adverse events, vital signs and laboratory safety data. A blood sample will be collected at each scheduled visit prior to administration of study medication and analyzed for free and total IgE levels and total
| Enrollment: | 95 |
| Study Start Date: | May 2003 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (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 who completed core study and extension study CIGE24IA05E1 up to and including visit 15, without experiencing any significant drug-related adverse events
- Patients who have given written informed consent
Exclusion Criteria:
- Patients who had not received study medication for greater than 84 days since visit 15 of study CIGE24IA05E1
- 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: | NCT00482508 History of Changes |
| Other Study ID Numbers: | CIGE025IA04E2 |
| Study First Received: | June 4, 2007 |
| Last Updated: | October 24, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices France: French Health Products Safety Agency (Afssaps) Spain: Spanish Drug Agency Switzerland: Swiss Medic United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Novartis:
|
Asthma anti immunoglobulin E omalizumab |
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 16, 2013