A Study to Evaluate Biomarkers in Chronic Obstructive Pulmonary Disease

This study has been terminated.
(Study was completed with 69 subjects enrolled due to difficult enrolment and adequate biomarker data was avaible with 69 subjects in the study.)
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01268072
First received: December 28, 2010
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

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


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study to Evaluate Biomarkers in Acute Exacerbations in Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Identify biomarkers for evaluation of efficacy in subjects presenting with AECOPD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Hospitalization, treatment and discharge of COPD subjects [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Symptom, physiological data, blood, and sputum.


Enrollment: 61
Study Start Date: February 2011
Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

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.
  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: NCT01268072

Locations
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Research Site
Springfield, Massachusetts, United States, 01199
United States, Missouri
Research Site
St. Louis, Missouri, United States, 63110
United States, New York
Research Site
Buffalo, New York, United States, 14215
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19140
Research Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Research Site
Providence, Rhode Island, United States, 02903
United States, Texas
Research Site
Houston, Texas, United States, 77030
Canada, Quebec
Research Site
Sainte-Foy, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Joseph Parker, MD MedImmune LLC
  More Information

Additional Information:
No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01268072     History of Changes
Other Study ID Numbers: MI-CP221
Study First Received: December 28, 2010
Last Updated: February 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by MedImmune LLC:
COPD

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

ClinicalTrials.gov processed this record on September 22, 2014