A study to evaluate the effect of omalizumab on asthma impairment in patients with persistent allergic asthma

Phase 1

• Conditions: Allergic asthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-001799-41-Outside-EU/EEA
• Lead Sponsor: ovartis Pharmaceutical Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-03
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

Inclusion Criteria:

•Total Asthma Control Test (ACT) score of =19 plus at least one of the following in the 4 weeks preceding visit 1, on average:
?Symptoms > 2 days/week
?Night-time awakenings =1 time/week
?Short-acting beta2-agonist (SABA) use for symptom control >2 days/week forced expiratory volume in 1 second (FEV1) = 80% predicted

Are the trial subjects under 18? yes
Number of subjects for this age range: 19
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 239
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

Exclusion Criteria:
•History of intubation for asthma.
•An asthma exacerbation requiring treatment with systemic steroids within 4 weeks of screening (Visit 1).
•Less than 3 months of stable maintenance oral corticosteroid therapy for asthma

Study & Design

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