A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease (SPRING)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01448850
First received: October 6, 2011
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Biological: MEDI8968 SC for 12 months
Biological: Placebo SC for 12 months
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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 [ Time Frame: Approximately 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 464
Study Start Date: November 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MEDI8968
Subjects will receive MEDI8968.
Biological: MEDI8968 SC for 12 months
Drug
Placebo Comparator: Placebo
Subjects will receive placebo
Biological: Placebo SC for 12 months
Simulated medical intervention

Detailed Description:

A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448850

  Show 61 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Rene Van Der Merwe, MBChB, MFPM MedImmune Ltd
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01448850     History of Changes
Other Study ID Numbers: CD-RI-MEDI8968-1103
Study First Received: October 6, 2011
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
Chronic Obstructive Pulmonary Disease (COPD)

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014