Protein Biomarker Discovery and Validation in Chronic Obstructive Pulmonary Disease (COPD) And Asthma

Terminated

Brief Summary: The purpose of the study is to better understand proteomics of asthma and COPD, and response to therapy. There are two Phases to this study broken into two arms. In Phase I, we propose is to use discovery proteomics and techniques to identify protein expression signatures. Subjects who complete Phase I are eligible, but not required, to enroll in Phase II. In Phase II, we propose to establish and validate the predictive value of protein signatures for treatment responses using inhaled corticosteroids.

Detailed Description: There are two Phases to this study broken into two arms. In Phase I, our propose to use discovery proteomics and high throughput techniques to identify protein expression signatures. The total planned size of Phase I is 100 patients. Patients will be divided into two arms based on disease status (COPD or asthma). Active smoking will be defined as daily use of cigarettes, pipes, cigarillos or cigars at time of entry into the study and through duration of study. No active smoking defined as never smoking or having stopped smoking for 5 years or greater.

In the Phase II, we aim to establish and validate the predictive value of proteomic signatures for therapeutic responses using inhaled corticosteroids. For Phase II, subjects who completed Phase I are eligible, but not required to participate in Phase II.

Recruitment & Eligibility

Inclusion Criteria

INCLUSION

History consistent with asthma: episodic wheezing, shortness of breath, or cough
Airway lability recognized by at least 12% improvement in Forced Expiratory Volume (FEV1) after 2 puffs of beta2 agonist Age >18yrs
FEV1 >40% predicted
Never smoker, current smoker, or quit smoking ≥5 years ago Criteria for COPD

INCLUSION

History consistent with COPD: dyspnea with exertion, productive cough, progressive course
Smoking history of at least 20 pack years
Current smoker or quit smoking ≥5 years ago
Age >18yrs
FEV1: Forced Vital Capacity (FVC) ratio < 0.70 following 2 puffs of albuterol
FEV1 greater than 50% predicted

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Asthma Non-Smoker Subjects	Exhaled Breath Condensate (EBC)	Non-Smokers Subjects with no active smoking. No active smoking defined as never smoking or having stopped smoking for 5 years or greater.
COPD Smoker Subjects	Exhaled Breath Condensate (EBC)	Smokers Active smoking will be defined as daily use of cigarettes, pipes, cigarillos or cigars at time of entry into the study and through duration of study.

Primary Outcome Measures

Name	Time	Method
Exhaled Breath Condensate Protein Concentration	1 year through study completion	Protein concentrations were below the limit of detectability and are not scientifically robust.

Secondary Outcome Measures