A Phase 2 study to test how effective MEDI8968 is in treating subjects with chronic bronchitis, emphysema, or both, in which airflow to the lungs is restricted.
- Conditions
- Chronic Obstructive Pulmonary DiseaseMedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2011-002563-23-GB
- Lead Sponsor
- MedImmune Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 324
- Age 45 through 75 years.
- Predicted (GOLD stage II, III, and IV) at screening.
- History of previous AECOPD 12 months prior to screening Clinically stable and free from an AECOPD for 8 weeks prior to Day 1.
- Current smoker or ex-smoker with a tobacco history of = 10 pack-years
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 230
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
- Past or present disease or disorder,
- Significant or unstable ischemic heart disease, etc
- Known history of allergy or reaction to any component of the IMP
- Past or current malignancy within the past 5 years
- Subjects have had a chest x-ray or CT scan suggestive of malignancy or tuberculosis (TB).
- Use of immunosuppressive medication receipt of any biologic agent
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