A Study to Evaluate Biomarkers in Chronic Obstructive Pulmonary Disease

A Prospective Observational Study to Evaluate Biomarkers in Acute Exacerbations in Chronic Obstructive Pulmonary Disease

The primary objective of this study is to identify biomarkers that can be used for evaluation of efficacy in subjects presenting with AECOPD

Study Overview

• Status: Terminated
• Conditions: Chronic Obstructive Pulmonary Disease

Detailed Description

Identify biomarkers that can be used for evaluation of efficacy in subjects presenting with AECOPD by evaluating longitudinal changes and the interrelationship of blood and sputum biomarkers with physiological endpoints and symptom measures in stable subjects with COPD likely to experience a future AECOPD, and in subjects during severe AECOPD.

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sainte-Foy, Quebec, Canada, G1V 4G5
      • Research Site
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Research Site
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Research Site
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Research Site
  • New York
    • Buffalo, New York, United States, 14215
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • Research Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Research Site
  • Texas
    • Houston, Texas, United States, 77030
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The subjects in this study will be adult males or females, ≥40 years of age, at increased risk for AECOPD (Cohort 1) or who present with severe AECOPD requiring hospitalization (Cohort 2).

Description

Inclusion Criteria:

• Age ≥ 40 years at the time of screening
• Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
• Cohort 1 only: A primary diagnosis of clinically stable physician-diagnosed COPD upon entry into the study meeting one of the following criteria:
• Subjects who have experienced a severe AECOPD requiring inpatient hospitalization in the previous 12 months
• Subject who had one severe AECOPD requiring ED visits in the past 9 months
• Subjects who are currently on LTOT.
• Cohort 1 only: Stable COPD for 4 weeks prior to screening, as defined by no change in ICS therapy and no use of oral corticosteroids or antibiotics for a respiratory tract infection.
• Cohort 1 only: Forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) < 0.70 or lower limits of normal (LLN).
• Cohort 1 only: FEV1 < 60% predicted normal value.
• Cohort 2 only: A primary diagnosis of physician-diagnosed AECOPD requiring admission to the hospital.
• Current smoker or ex-smoker with a tobacco history of ≥ 10 pack-years (one pack year = 20 cigarettes smoked per day for 1 year).
• Ability and willingness to complete the appropriate follow-up period of time as required by the protocol.
• Able to read and write and use the electronic devices (English or Spanish version).

Exclusion Criteria:

• Participation (defined as administration of at least one dose of investigational product) in another clinical study, the last follow-up visit of which is within 12 weeks (for a small molecule drug) and (6 months for a large molecule drug) of entry into this study.
• Any condition that, in the opinion of the investigator would interfere with interpretation of subject safety or study results.
• Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
• The presence of another chronic pulmonary or systemic disease, which in the opinion of the investigator or medical monitor might affect the analysis of the data (eg, idiopathic pulmonary fibrosis, sarcoidosis, active cancer or autoimmune disease).
• History of immunodeficiency.
• Current alcohol or drug abuse or a history of unsuccessfully treated alcohol or drug abuse within the past year.
• Cohort 2 only: Diagnosis of an acute disease/condition (eg, congestive heart failure, acute myocardial infarction, pneumonia, or pulmonary embolus) that is the primary reason for the subject's hospitalization.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort 2; Subjects who are recruited on admission to hospital for AECOPD.
Cohort 1; Subjects with COPD who are stable, but at risk of presenting with an AECOPD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify biomarkers for evaluation of efficacy in subjects presenting with AECOPD	Investigate changes in physiological measures, symptoms, and blood, urine and sputum biomarkers in subjects with stable COPD during AECOPD, and as subjects return to clinical stability.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization, treatment and discharge of COPD subjects	Gain an understanding of the reasons subjects with COPD may be hospitalized for their AECOPD and to understand the criteria physicians use for treatment and discharge.	12 months

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Investigators: Study Director: Joseph Parker, MD, MedImmune LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: December 28, 2010
• First Submitted That Met QC Criteria: December 28, 2010
• First Posted (Estimate): December 29, 2010

Study Record Updates

• Last Update Posted (Estimate): February 20, 2013
• Last Update Submitted That Met QC Criteria: February 18, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: MI-CP221