Protein Biomarker Discovery and Validation in Chronic Obstructive Pulmonary Disease (COPD) And Asthma
Protein Biomarker Discovery and Validation in Chronic Obstructive Pulmonary Disease (COPD) And Asthma
The purpose of the study is to better understand the function of asthma and COPD, and
 response to therapy. There are two Phases to this study broken into two arms. In Phase I, our
 propose is to use discovery proteins and techniques to identify protein expression
 signatures. In Phase II, is to establish and validate the predictive value of protein
 signatures for treatment responses using inhaled corticosteroids.
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 identical arms based on smoking status. One arm will contain subjects who are active
 smokers and the other arm will contain subjects with no active smoking. 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. Each arm will contain 50 subjects, 26 with COPD
 (Stage II and III with 13 subjects in each) along with 24 asthmatics (Mild to Moderate
 disease with 12 subjects in each). The investigators will not recruit Stage IV COPD due to
 the heightened risk of bronchoscopy in these patients.

 In the second Phase, is to establish and validate the predictive value of proteomic
 signatures for therapeutic responses using inhaled corticosteroids. For Phase II, the
 investigators will recruit a total of 80 subjects that will include subjects who are
 continuing in the study from Phase I. Patients continuing from Phase I will wait 4-6 weeks
 from bronchoscopy before starting Phase II. This will be done in order to avoid having the
 prior bronchoscopy affecting the Phase II results. Phase II will again be divided into two
 arms based on active smoking status as discussed previously. Each arm will contain 40
 subjects, 20 with COPD (Stage II and III with 10 subjects in each) along with 20 asthmatics
 (Mild to Moderate disease with 10 subjects in each).
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