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.

Phase 1

Conditions: Chronic Obstructive Pulmonary Disease
MedDRA version: 16.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2011-002563-23-CZ

Lead Sponsor: MedImmune Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

- 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

Exclusion Criteria

- 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
Main Objective: To evaluate the effect of MEDI8968 on the rate of acute exacerbations of COPD (AECOPD) in adult subjects with COPD; GOLD II-IV on standard maintenance therapy;Secondary Objective: To evaluate the safety and tolerability of MEDI8968.<br>To evaluate the effect of MEDI8968 on the number of hospitalizations due to AECOPD, time to first AECOPD event and quality of life.;Primary end point(s): Rate of moderate or severe AECOPD;Timepoint(s) of evaluation of this end point: At the point that the average number of exacerbations has reached 0.6 per patient; at approximatley 6 months.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Safety and tolerability of MEDI8968<br>- Additional efficacy endpoints regarding rate and severity of AECOPD and quality of life<br>- Pharmacokinetic and immunogenicity analysis;Timepoint(s) of evaluation of this end point: 69 weeks