A Study to Evaluate Biomarkers in Chronic Obstructive Pulmonary Disease

NCT01268072 | Terminated

• 1 other identifier: MI-CP221
• Study Type: observational
• Target: 61
• Locations: 2 countries
• Sites: 10

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hospitalization, treatment and discharge of COPD subjects

  12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (10)

Research Site

Baltimore, Maryland, 21201, United States

Location

Research Site

Springfield, Massachusetts, 01199, United States

Location

Research Site

St Louis, Missouri, 63110, United States

Location

Research Site

Buffalo, New York, 14215, United States

Location

Research Site

Cincinnati, Ohio, 45267, United States

Location

Research Site

Philadelphia, Pennsylvania, 19140, United States

Location

Research Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Research Site

Providence, Rhode Island, 02903, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Research Site

Sainte-Foy, Quebec, G1V 4G5, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Symptom, physiological data, blood, and sputum.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph Parker, MD

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: December 29, 2010
• Study Start: February 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: January 1, 2013
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

CA (1); US (9)