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

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Medical Conditions
  • Chronic Obstructive Pulmonary Disease
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT01448850

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
The purpose of this study is to evaluate the effect of MEDI8968 on the rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with symptomatic, moderate to very severe COPD (Global Initiative for Chronic Obstructive Lung Disease - GOLD stage II-IV) receiving standard maintenance therapy for the underlying disease condition.
Research Details
  • A Phase 2 double-blind, placebo-controlled study to evaluate the efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease. The study will have a screening phase of 23 days, treatment phase from Week 1 to 53 and follow-up phase from Week 53 to 69. Participants will receive either MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by 300 mg injection subcutaneously (SC) every 4 weeks up to Week 53 or matching placebo in the same fashion. Participants will primarily be assessed for incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Safety will be monitored throughout the study.
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Biological : MEDI8968 600 mg IV, 300 mg SC, Other : Placebo

Study Arm Groups : MEDI8968 600 mg IV, 300 mg SC, Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
    Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD); Day 1 up to 393
Secondary Outcome Measures
    Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD); Day 1 up to 393; Time to First Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD); Day 1 up to 393; Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53; Baseline and Week 53; Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score; Week 53; Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score at Week 53; Baseline and Week 53; Percentage of Participants With Improvement in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score; Baseline and Week 53; Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs); Day 1 up to Week 69; Observed Serum Concentrations of MEDI8968; Pre-dose (Baseline), Post-dose on Week 53; Number of Participants Exhibiting Anti-Drug Antibodies for MEDI8968 at Any Visit; Day 1 up to Week 69
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
45 Years - 75 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 (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II, III, and IV) at Screening

    - History of previous acute exacerbations of chronic obstructive pulmonary disease (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 more than or equal to (>=) 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 investigational manufacturing product (IMP)

    - Past or current malignancy within the past 5 years

    - Subjects have had a chest x-ray or Computed Tomography (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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
Cambridge
Cambridgeshire
Newcastle upon Tyne
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
Bulgaria, Czech Republic, Hungary, Latvia, Lithuania, Philippines, Poland, Ukraine, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 added to source

06 Oct 2011

Date updated in source

30 Nov 2016