A Study to Evaluate Biomarkers in Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01268072
• Other study ID #: MI-CP221
• Status: Terminated
• Phase: N/A
• First received: December 28, 2010
• Last updated: February 18, 2013
• Start date: February 2011
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: January 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Canada	Research Site	Sainte-Foy	Quebec
United States	Research Site	Baltimore	Maryland
United States	Research Site	Buffalo	New York
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Houston	Texas
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Providence	Rhode Island
United States	Research Site	Springfield	Massachusetts
United States	Research Site	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.