A clinical trial to investigate the effects of MEDI9929, a drug used in clinical research, in adults with uncontrolled, severe asthma, a disease that causes variable and recurring inflammation of the airways leading to difficulty in breathing.
- Conditions
- AsthmaMedDRA version: 19.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
- Registration Number
- EUCTR2013-003269-33-SK
- Lead Sponsor
- MedImmune LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 552
• Age and weight range as defined in the protocol.
• Documented Physician-diagnosed asthma in line with the protocol requirements.
• Subjects must have received a physician-prescribed asthma controller
regimen as outlined in the protocol.
• Able to meet the pulmonary function requirements and other defined asthma metrics/measures as outlined in the study protocol.
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 510
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42
• Established diagnosis of occupational asthma.
• Current smokers or subjects with a smoking history of = 10 pack years.
• Any concomitant respiratory disease, including acute upper or lower respiratory infections.
• Known history of active tuberculosis (TB).
• Receipt of any marketed or investigational biologic agent within 4 months or 5 half lives prior to Visit 1 (Week 5), whichever is longer.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method