Protein Biomarker Discovery and Validation in Chronic Obstructive Pulmonary Disease (COPD) And Asthma
| Status: | Terminated |
|---|---|
| Conditions: | Asthma, Chronic Obstructive Pulmonary Disease |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/28/2017 |
| Start Date: | May 2014 |
| End Date: | June 2017 |
Protein Biomarker Discovery and Validation in 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.
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).
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
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