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CLINICAL TRIALS PROFILE FOR PULMICORT

Clinical Trials for Pulmicort

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00005880	Budesonide in Treating Former and Current Smokers With Bronchial Dysplasia	Completed	National Cancer Institute (NCI)	Phase 2	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of budesonide may be an effective way to prevent bronchial dysplasia. PURPOSE: Randomized double-blinded phase II trial to determine the effectiveness of budesonide in treating former or current smokers who have bronchial dysplasia.
NCT00005880	Budesonide in Treating Former and Current Smokers With Bronchial Dysplasia	Completed	British Columbia Cancer Agency	Phase 2	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of budesonide may be an effective way to prevent bronchial dysplasia. PURPOSE: Randomized double-blinded phase II trial to determine the effectiveness of budesonide in treating former or current smokers who have bronchial dysplasia.
NCT00146497	Cytokine Change in Bronchoalveolar Lavage Fluid After Early Budesonide-Surfactant Treatment in Premature Infants	Terminated	China Medical University Hospital	Phase 4	Pulmonary inflammation plays an important role in the development of chronic lung disease (CLD) in preterm infants. This inflammation occurs very early in postnatal life. Any therapy that could be beneficial in preventing CLD should be started very early. The investigators' previous double-blind study has shown that early (< 12 hours) postnatal use of intravenous dexamethasone for 4 weeks significantly suppressed pulmonary inflammation and significantly reduced the incidence of CLD. However, the use of dexamethasone was associated with increased incidence of infection and sepsis. Their follow-up study also suggested an increase in the incidence of psychomotor anomalies. As compared to intravenous administration, endotracheal instillation will provide more local anti-inflammatory effects and less systemic side effects. Infants will be eligible for the study if their birth weight (BW) is < 1500 gm and if they had severe respiratory distress syndrome (RDS) requiring mechanical ventilation shortly after birth. After informed consent is obtained, the infant will be randomly assigned depending on the condition of the infant. The primary outcome is the change in cytokines (interleukin-6, 8, 10 and TNF-α) levels in BAL fluid. Chronic lung disease (CLD) was judged at 36 postmenstrual weeks. Infants in the study group (S/B group) received surfactant (Survanta®, Abbott Laboratories, North Chicago, IL; 100 mg or 4 mL/kg/dose) and Budesonide (Pulmicort®, AstraZeneca Pty Ltd., Australia; 0.5 mg or 1mL/kg/dose), while those in the control group (S group) received surfactant (Survanta® Abbott, 100 mg/kg/dose) and saline (1mL/kg).
NCT00175747	A Phase IIb Trial of Pulmicort Turbuhaler (Budesonide)	Completed	National Cancer Institute (NCI)	Phase 2/Phase 3	Studies in animals suggest that inhaled budesonide may prevent the occurrence of lung cancer. We conducted a clinical trial to determine the effects of inhaled budesonide in smokers who had precancerous lesions in the breathing tubes (i.e. bronchial dysplasia.
NCT00175747	A Phase IIb Trial of Pulmicort Turbuhaler (Budesonide)	Completed	University of British Columbia	Phase 2/Phase 3	Studies in animals suggest that inhaled budesonide may prevent the occurrence of lung cancer. We conducted a clinical trial to determine the effects of inhaled budesonide in smokers who had precancerous lesions in the breathing tubes (i.e. bronchial dysplasia.
Trial ID	Title	Status	Sponsor	Phase	Summary