A Double-Blinded, Placebo-Controlled, Parallel Group Study Of Uridine 5'-Triphosphate (UTP) Solution For Inhalation As An Adjunct In The Diagnosis Of Lung Cancer By Sputum Cytology

OBJECTIVES:

• Compare the number of lung cancer diagnoses obtained from cytological evaluation of sputum expectorated after inhalation of INS316 versus normal saline as an adjunct for spontaneous expectoration of sputum in patients with suspected lung cancer.
• Compare the relative sensitivity of sputum cytology in the diagnosis of primary lung cancer using these methods of sputum collection in these patients.
• Compare the amount of sputum collected from patients using these methods.
• Correlate the number of macrophages in sputum with the predictive likelihood of obtaining a positive diagnosis by sputum cytology in these patients.
• Determine whether specificity of sputum cytology is adversely affected by induction with INS316 in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel, multicenter study. Patients are stratified according to tumor size and location as visualized by chest radiography, CT scan, or positron-emission tomography scan (peripheral tumor (distal to the subsegmental bronchi) no greater than 2 cm in diameter vs peripheral tumor greater than 2 cm in diameter vs central tumor no greater than 2 cm in diameter vs central tumor greater than 2 cm in diameter). Patients are randomized to one of two arms.

Prior to dosing with sputum induction adjunct, all patients expectorate sputum spontaneously.

• Arm I: Patients receive a single dose of INS316 by inhalation.
• Arm II: Patients receive a single dose of placebo (normal saline) by inhalation.