A Study to Evaluate Biomarkers in Chronic Obstructive Pulmonary Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Biomarkers of Early Chronic Obstructive Pulmonary Disease (COPD) in Smokers - Longitudinal Study

NCT02076061

Chronic Obstructive Pulmonary Disease Cardiovascular Disease Lung Cancer

COMPLETED

A Study of the Inflammatory Pathways Associated With Chronic Obstructive Pulmonary Disease Exacerbations

NCT01337661

Chronic Obstructive Pulmonary Disease

COMPLETED

Biomarkers of Chronic Obstructive Pulmonary Disease

NCT04963023

COPD Asthma-COPD Overlap Syndrome Asthma

COMPLETED

Markers of COPD Exacerbations

NCT05315674

COPD COPD Exacerbation

RECRUITING

Longitudinal Follow up to Assess Biomarkers Predictive of Emphysema Progression in Patients With COPD (Chronic Obstructive Pulmonary Disease)

NCT02719184

Pulmonary Disease, Chronic Obstructive Pulmonary Emphysema

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 2

Subjects who are recruited on admission to hospital for AECOPD.

No interventions assigned to this group

Cohort 1

Subjects with COPD who are stable, but at risk of presenting with an AECOPD.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No