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NCT00482248 Clinical Trial

Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00482248
Other study ID # CIGE0250011E3
Secondary ID
Status Completed
Phase Phase 3
First received June 4, 2007
Last updated November 16, 2016
Start date June 2003
Est. completion date June 2006

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Canada: Health CanadaItaly: Direzione Generale di Sanità Veterinaria e degli AlimentiRussia: Ministry of Public HealthSweden: Medical Products AgencyNetherlands: Medicines Evaluation Board (MEB)Czech Republic: State Institute for Drug ControlUnited Kingdom: Medical and Healthcare Products Regulatory Agency (MHRA)
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers
Gender Both
Age group 12 Years to 75 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Omalizumab

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Novartis Genentech, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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