Flora to provide confirmation: A study evaluating the efficacy of QGE031 compared to omalizumab in patients with allergic asthma.

• Conditions: asthma; MedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-003350-84-SE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-19
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

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

Inclusion Criteria

Adult patients 18 to 65 years
Positive skin prick test to one or more common airborne allergens
Presence of airway hyperresponsiveness documented by a provocative concentration of methacholine causing a 20% fall in FEV1 (PC20 FEV1) of less than or equal to 16 mg/mL
Presence of an early asthmatic response demonstrated by an allergen challenge at screening and including a 15% fall in the FEV1
Patients with a body weight and total IgE in a range specified by local country prescribing information for omalizumab

Additional inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnant or nursing (lactating) women.
Women of child-bearing potential unless they are using a highly effective method of birth control (as further defined in the study protocol)
Smokers
Patients with poorly controlled asthma or patients who have had an asthma exacerbation within the past year

Additional exclusion criteria may apply.

Study & Design

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