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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01448850
First received: October 6, 2011
Last updated: November 9, 2012
Last verified: November 2012
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 300
Study Start Date: December 2011
Estimated Study Completion Date: April 2014
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448850

  Show 66 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: November 9, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 16, 2013