Tuesday, August 3, 2010

Another Day, Another Drug Study

Can I just say, I love me some drug studies! I'm pretty much on a schedule now of doing drug studies back-to-back-to-back and so on and I'm already plotting the next one I'd like to do. I figured though that I'd fill you guys in on the one that I started today. Actually, I misspoke, I sort of started it today. I went in to give blood and urine so they could establish a baseline to compare the rest of the data with. Friday is the big day in which I actually get to take one of two doses of the drug or a placebo. I of course hope I get the real deal, but hey, somebodies got to take the sugar pill right?

Ok, so what is this drug? Since I'm no medical mind and although I have a pretty good idea of what it is supposed to do according to my doc, I still won't attempt to answer. I will however let Clinical Trials Feeds give you their answer:

Official Title: “A Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients With Cystic Fibrosis”

Study Drug, SB-656933, is a selective CXCR2 antagonist in development as a novel, once-daily oral anti-inflammatory agent for the maintenance treatment of Cystic Fibrosis (CF) and Chronic Obstructive Pulmonary Disease (COPD). We want to find out if this experimental drug will help decrease inflammation and slow the progression of lung disease. This study compares how well different doses of the experimental study drug (SB-656933) control inflammation in patients with CF. Two doses of the study drug will be assessed against placebo to see which dose works best.

And how will they know if this stuff works? Well, we have to go to ClinicalTrials.gov for that:

Primary Outcome Measures:
  • Safety and tolerability of SB-656933 in subjects with cystic fibrosis, including, adverse events, vital signs, clinical laboratory assessments (hematology, chemistry, urinalysis, and VB-1),electrocardiographic (ECG)parameters,and exacerbation of CF [ Time Frame: 28 days and followup ]

Secondary Outcome Measures:
  • Sputum microbiology at 28 days as measured by bacterial colony counts of Pseudomonas aeruginosa and Staphylococcus aureus [ Time Frame: 28 days ]
  • Induced sputum neutrophil number (cells/mL) and percentage (%) [ Time Frame: 28 days ]
  • Induced sputum inflammatory markers: (e.g. but not limited to: NE, MPO, total protein). [ Time Frame: 28 days ]
  • FEV1 and FVC [ Time Frame: 28 days and followup ]
  • Serum and plasma markers of inflammation: (e.g. but not limited to: fibrinogen, CRP, CC-16, MMP8, MMP9, SP-D, CXCL8 (IL-8)) [ Time Frame: 28 days ]
  • Daily Respiratory Symptom Diary for Cystic Fibrosis (Self Reported Version (Exploratory)) [ Time Frame: 28 days ]
  • Plasma SB-656933 concentrations and pharmacokinetic parameters including area under the plasma drug concentration vs time curve (AUC(0-24), AUC(0-infinity)),maximum observed plasma drug concentration (Cmax)and time to maximum observed plasma drug consent [ Time Frame: 28 days ]
So needless to say, I'm hoping this sucker works cause inflammation is definitely something I battle. I will keep you guys posted on how it's going and let's all hope that this can be another gun in our arsenal in the next handful of years. I guess I better go read the disclosure clause in the contract now :)