Compaction assay for assessment of respiratory disease therapy

Abstract

A compaction assay measuring the viscoelasticity of sputum samples of patients subject to respiratory disease is provided. This assay is useful in determining the therapeutic efficacy of DNase, antibiotic and other respiratory disease treatments in improving lung function.

1 . A method for measuring the compaction of a sputum sample from a mammalian patient subject to respiratory disease associated with infected airway secretions, comprising obtaining a sputum sample from the mammalian patient, centrifuging said sputum sample until fractionated into supernatant and pellet phases, and measuring the pellet.  
     
     
         2 . The method of  claim 1  wherein diluent is added to the sputum sample prior to centrifugation.  
     
     
         3 . The method of  claim 2  wherein the diluent is water added in a volume equaling 50% of the sputum weight.  
     
     
         4 . The method of  claim 1  wherein said mammalian patient sputum is from a patient subject to cystic fibrosis.  
     
     
         5 . The method of  claim 1  wherein said mammalian patient sputum is from a patient subject to pneumonia.  
     
     
         6 . The method of  claim 1  wherein said mammalian patient sputum is from a patient subject to bronchitis.  
     
     
         7 . The method of  claim 1  wherein said mammalian patient sputum is from a patient subject to sinus infections.  
     
     
         8 . The method of  claim 1  wherein said mammalian patient has been treated with a therapeutic.  
     
     
         9 . The method of  claim 1  wherein said mammalian patient has been treated with DNase.  
     
     
         10 . The method of  claim 1  wherein said mammalian patient has been treated with chest physiotherapy.  
     
     
         11 . A method for measuring the compaction of a mammalian patient sputum sample treated in vitro with a therapeutic, comprising obtaining a sputum sample from the mammalian patient, adding therapeutic to the sputum sample, centrifuging said sputum sample until fractionated into supernatant and pellet phases, and measuring the pellet.  
     
     
         12 . The method of  claim 11  wherein said mammalian patient sputum is from a patient subject to respiratory disease associated with infected airway secretions.  
     
     
         13 . The method of  claim 11  wherein said respiratory disease is cystic fibrosis.  
     
     
         14 . The method of  claim 11  wherein said respiratory disease is bronchitis.  
     
     
         15 . The method of  claim 11  wherein said respiratory disease is pneumonia.  
     
     
         16 . The method of  claim 11  wherein said therapeutic useful in the treatment of respiratory disease is rhDNase.  
     
     
         17 . The method of  claim 11  wherein said therapeutic useful in the treatment of respiratory disease is an antibiotic.  
     
     
         18 . The method of  claim 11  wherein the therapeutic is added in a volume equaling 50% of the of the sputum sample weight.  
     
     
         19 . A method of assaying the compaction of a DNase treated sputum sample from a mammalian patient in need of DNase therapy comprising, obtaining a sputum sample from the mammalian patient, adding DNase to the sputum sample, centrifuging the DNase treated sputum until fractionated into supernatant and pellet phases, and measuring the pellet.  
     
     
         20 . The method of  claim 19  wherein said mammalian patient is human and said DNase is recombinant human DNase I (rhDNase I).  
     
     
         21 . The method of  claim 19  wherein said recombinant human DNase I is in a concentration of at least 1 μg rh DNase I/mL sputum.  
     
     
         22 . The method of  claim 19  wherein said DNase is added in a volume equaling 50% of the sputum weight.