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

Study Overview
=================
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.

Official Title
-----------------
Protein Biomarker Discovery and Validation in COPD And Asthma

Conditions
-----------------
Asthma, COPD

Intervention / Treatment
-----------------
* Procedure: Exhaled Breath Condensate (EBC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Criteria for Asthma 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: Exclusion for Asthma EXCLUSION Other respiratory illness other than asthma Chronic infectious process Significant other medical illness Inability to consent Pregnancy Exclusion for COPD EXCLUSION Other respiratory illness other than COPD Chronic infectious process Significant other medical illness Inability to consent Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD Smoker Subjects<br>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. | Procedure: Exhaled Breath Condensate (EBC)<br>* Collection of EBC condensate<br>|
| Asthma Non-Smoker Subjects<br>Non-Smokers Subjects with no active smoking. No active smoking defined as never smoking or having stopped smoking for 5 years or greater. | Procedure: Exhaled Breath Condensate (EBC)<br>* Collection of EBC condensate<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled Breath Condensate Protein Concentration | Protein concentrations were below the limit of detectability and are not scientifically robust. | 1 year through study completion |