Safety and Tolerability of Omalizumab in Poorly Controlled Moderate to Severe Asthma Patients

Sponsor
Novartis
Study ID
NCT00482508
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
May 31, 2003
Status verified
Oct 2011
Primary completion
Oct 31, 2005
Completion
Oct 31, 2005

Study Design

Enrollment
95 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

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

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