The effect of Omalizumab on asthma control

Phase 1

• Conditions: Asthma; MedDRA version: 16.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2009-009154-25-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-15
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Males and females aged 18 to 75 years inclusive.
Moderate/severe non-atopic asthma treated with inhaled
corticosteroid, with or without oral corticosteroids(oral, up to 20mg/day prednisolone
or equivalent) for at least 3 months prior to screening.
Written, informed consent provided.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Smoking within the last 3 months or total smoking history 10 pack years.
Pregnant or lactating females or those at risk of pregnancy.
Patients taking >20mg of prednisolone daily.
Hospitalisation for asthma or exacerbation requiring systemic corticosteroid therapy
within 3 months of the screening visit.
History of life-threatening asthma, defined as an asthma episode that required
intubation and/or was associated with hypercapnia, respiratory arrest and/or hypoxic
seizures within the 6 months prior to screening.
Pre bronchodilator FEV1 < 40% of the predicted.
Patients in whom, in the opinion of the study investigators, omalizumab therapy
might normally require precaution (current or suspected malignancy, current or
suspected autoimmune disease, renal or hepatic impairment, hyperimmunoglobulin E
syndrome, allergic bronchopulmonary aspergillosis , diabetes mellitus, current
immunosuppressive therapy and known Churg-Strauss or hypereosinophilic
syndrome).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified