Therapeutic combination comprising a pulmonary surfactant and a steroid for the prophylaxis of bpd

Abstract

Administering a pulmonary surfactant and a corticosteroid in a low dose is effective for the prophylaxis of bronchopulmonary dysplasia (BPD) in preterm neonates.

1 . A composition, comprising:
 (a) at least one pulmonary surfactant; and   (b) budesonide,   wherein said budesonide is present in an amount sufficient to deliver a dose of about 0.01 to about 0.1 mg/kg of body weight to a preterm neonate.   
     
     
         2 . A composition according to  claim 1 , which comprises budesonide in an amount sufficient to deliver a dose of about 0.02 to about 0.09 mg/kg of body weight to a preterm neonate. 
     
     
         3 . A composition according to  claim 1 , which comprises budesonide in an amount sufficient to deliver a dose of about 0.03 to about 0.08 mg/kg of body weight to a preterm neonate. 
     
     
         4 . A composition according to  claim 1 , which comprises budesonide in an amount sufficient to deliver a dose of about 0.04 to about 0.07 mg/kg of body weight to a preterm neonate. 
     
     
         5 . A composition according to  claim 1 , which comprises said at least one pulmonary surfactant in an amount sufficient to deliver a dose of about 100 to about 200 mg/kg a preterm neonate. 
     
     
         6 . A composition according to  claim 1 , which comprises poractant alfa. 
     
     
         7 . A composition according to  claim 1 , which is in a form of an aqueous suspension comprising a pharmaceutically acceptable carrier. 
     
     
         8 . A kit, comprising:
 (a) a pulmonary surfactant in an amount sufficient to deliver a dose of about 100 to about 200 mg/kg, to a preterm neonate, and a pharmaceutically acceptable carrier or diluent in a first unit dosage form;   (b) budesonide in an amount sufficient to deliver a dose of dose of about 0.01 to about 0.1 mg/kg of body weight, to a preterm neonate, and a pharmaceutically acceptable carrier or diluent in a second unit dosage form; and   (c) a container for containing said first and second dosage forms.   
     
     
         9 . A method for the prophylaxis of bronchopulmonary dysplasia (BPD) in a preterm neonate, comprising administering to a preterm neonate at least one pulmonary surfactant and budesonide in a dose of about 0.01 to about 0.1 mg/kg of body weight. 
     
     
         10 . A method according to  claim 9 , wherein said pulmonary surfactant and budesonide are administered from the 1 st to the 4 th  day of life of the preterm neonate. 
     
     
         11 . A method according to  claim 9 , wherein said preterm neonate is kept under a non-invasive ventilation procedure. 
     
     
         12 . A method according to  claim 9 , wherein said non-invasive ventilation procedure is nasal CPAP. 
     
     
         13 . A method according to  claim 9 , wherein said budesonide is administered at a dose of about 0.02 to about 0.09 mg/kg of body weight. 
     
     
         14 . A method according to  claim 9 , wherein said budesonide is administered at a dose of about 0.03 to about 0.08 mg/kg of body weight. 
     
     
         15 . A method according to  claim 9 , wherein said budesonide is administered at a dose of about 0.04 to about 0.07 mg/kg of body weight. 
     
     
         16 . A method according to  claim 9 , wherein said at least one pulmonary surfactant and budesonide are administered simultaneously. 
     
     
         17 . A method according to  claim 9 , wherein said at least one pulmonary surfactant and budesonide are administered sequentially. 
     
     
         18 . A method according to  claim 9 , wherein said at least one pulmonary surfactant and budesonide are administered separately. 
     
     
         19 . A method according to  claim 9 , comprising administering said at least one pulmonary surfactant at a dose of about 100 to about 200 mg/kg. 
     
     
         20 . A method according to  claim 9 , comprising administering poractant alfa. 
     
     
         21 . A method according to  claim 9 , wherein said administering is administration by inhalation or intratracheal route. 
     
     
         22 . A method according to  claim 9 , wherein said at least one pulmonary surfactant and budesonide are administered in the form of an aqueous suspension comprising a pharmaceutically acceptable carrier. 
     
     
         23 . A method according to  claim 9 , wherein said preterm neonate is of a gestational age of 26 to 35 weeks. 
     
     
         24 . A method according to  claim 9 , wherein said preterm neonate is of a gestational age of 28 to 32 weeks. 
     
     
         25 . A method of improving lung function in a pre-term neonate, comprising the step of administering the composition of  claim 1 . 
     
     
         26 . A method of reducing lung inflammation in a pre-term neonate treated with mechanical ventilation, comprising the step of administering the composition of  claim 1  to said pre-term neonate, wherein said administration occurs during, before, or after said mechanical ventilation.