A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease | Completed
A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
SPRING
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Chronic Obstructive Pulmonary Disease
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01448850
Primary Trial ID Number
Summary
A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
Research Details
  • A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Biological : MEDI8968 SC for 12 months, Biological : Placebo SC for 12 months

Study Arm Groups : MEDI8968, Placebo

Intervention Type
See Interventions above
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; Approximately 12 months
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
45 Years - 80 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Research Site
Newcastle Upon Tyne
Cambridge
Research Site
Wolverhampton
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Bulgaria, Czech Republic, Hungary, Latvia, Lithuania, Philippines, Poland, Ukraine, United Kingdom
Scientific Title
A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CD-RI-MEDI8968-1103
Sponsor(s)
MedImmune LLC
Key Dates

Recruitment Start Date

Nov 2011

Recruitment End Date

Feb 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

06 Oct 2011

Last Updated

31 Mar 2014