Methods for Diagnosing and Treating Subjects for Pulmonary Exacerbation

Abstract

The present invention is related to novel methods for diagnosing and treating acute pulmonary exacerbation in subjects in need thereof.

What is claimed is: 
     
         1 . A method of diagnosing acute pulmonary exacerbation in a subject, said method comprising:
 a. obtaining a biological sample from the subject;   b. detecting the expression level of CD64 in the biological sample; and   c. diagnosing the subject as having acute pulmonary exacerbation when an elevated CD64 expression level from step b as compared to a control level is detected.   
     
     
         2 . The method of  claim 1 , wherein the subject has been diagnosed as having a disease selected from the group consisting of cystic fibrosis, asthma, chronic pulmonary obstructive disease, emphysema, interstitial lung disease, bronchitis, acute respiratory distress syndrome, and pneumonia. 
     
     
         3 . The method of  claim 1 , wherein the subject has been diagnosed as having cystic fibrosis. 
     
     
         4 . The method of  claim 1 , wherein the biological sample is whole blood, peripheral blood mononuclear cells (PBMCs), leukocytes, monocytes, lymphocytes, neutrophils, basophils, or eosinophils. 
     
     
         5 . The method of  claim 1 , wherein the biological sample is whole blood. 
     
     
         6 . The method of  claim 1 , wherein the expression level of CD64 is detected by quantitative PCR or quantitative flow cytometry (QFCM). 
     
     
         7 . The method of  claim 1 , further comprising measuring the subject's forced expiratory volume (FEV 1 ) and/or C-reactive protein (CRP) levels. 
     
     
         8 . The method of  claim 1 , wherein the method further comprises treating the subject. 
     
     
         9 . A method of treating a subject at risk for increased pulmonary exacerbation wherein the subject has experienced a previous pulmonary exacerbation, the method comprising:
 a. obtaining a biological sample from the subject;   b. detecting the expression level of CD64 in the biological sample;   c. identifying the subject as being at risk for increased pulmonary exacerbation when an elevated CD64 expression level from step b as compared to a control level is detected; and   d. treating the subject.   
     
     
         10 . The method of  claim 9 , wherein the subject has been diagnosed as having a disease selected from the group consisting of cystic fibrosis, asthma, chronic pulmonary obstructive disease, emphysema, interstitial lung disease, bronchitis, acute respiratory distress syndrome, and pneumonia. 
     
     
         11 . The method of  claim 9 , wherein the subject has been diagnosed as having cystic fibrosis. 
     
     
         12 . The method of  claim 9 , wherein the biological sample is whole blood, peripheral blood mononuclear cells (PBMCs), leukocytes, monocytes, lymphocytes, neutrophils, basophils, or eosinophils. 
     
     
         13 . The method of  claim 9 , wherein the biological sample is whole blood. 
     
     
         14 . The method of  claim 9 , wherein the expression level of CD64 is detected by quantitative PCR or QFCM. 
     
     
         15 . The method of  claim 9 , wherein the subject identified as having an increased risk for pulmonary exacerbation will have an increased risk of morbidity, mortality, and/or an increased risk for exacerbation recurrence. 
     
     
         16 . A method for detecting the presence of acute pulmonary exacerbation in a subject in need thereof, the method comprising
 a. obtaining a biological sample from the subject;   b. detecting the expression level of CD64 in the biological sample;   c. detecting the presence of acute pulmonary exacerbation in the subject when an elevated CD64 expression level from step b as compared to a control level is detected.   
     
     
         17 . The method of  claim 16 , wherein the subject has been diagnosed as having a disease selected from the group consisting of cystic fibrosis, asthma, chronic pulmonary obstructive disease, emphysema, interstitial lung disease, bronchitis, acute respiratory distress syndrome, and pneumonia. 
     
     
         18 . The method of  claim 16 , wherein the biological sample is whole blood, Peripheral Blood Mononuclear Cells (PBMCs), leuokocytes, monocytes, lymphocytes, neutrophils, basophils, or eosinophils. 
     
     
         19 . The method of  claim 16 , wherein the expression level of CD64 is detected by quantitative PCR or QFCM. 
     
     
         20 . The method of  claim 16 , further comprising treating the acute pulmonary exacerbation in the subject.