"Denufosol"

Long term effects of denufosol tetrasodium in patients with cystic fibrosis. Denufosol stimulates chloride secretion independent of the chloride channel which is dysfunctional in cystic fibrosis (CF) and therefore has the potential to benefit CF patients regardless of genotype. To assess the efficacy of denufosol in CF patients with mild lung function impairment age 5 years and older . This multicenter, randomized, parallel group double-blind placebo-controlled trial was conducted at 102 CF care centers in Australia, Canada and the United States (NCT00625612) The active group (n=233) received 60 mg denufosol via inhalation three times daily The primary efficacy endpoint was change in FEV(1) in liters from Day 0 to week 48. 685 patients were screened for the study and 466 patients (233 in each

Denufosol Tetrasodium in Patients with Cystic Fibrosis and Normal to Mildly Impaired Lung Function Intervention for cystic fibrosis lung disease early in its course has the potential to delay or prevent progressive changes that lead to irreversible airflow obstruction. Denufosol is a novel ion channel regulator designed to correct the ion transport defect and increase the overall mucociliary clearance in cystic fibrosis lung disease by increasing chloride secretion, inhibiting sodium absorption, and increasing ciliary beat frequency in the airway epithelium independently of cystic fibrosis transmembrane conductance regulator genotype. To evaluate the efficacy and safety of denufosol in patients with cystic fibrosis who had normal to mildly impaired lung function characteristic of early cystic

Resource use, costs, and utility estimates for patients with cystic fibrosis with mild impairment in lung function: analysis of data collected alongside a 48-week multicenter clinical trial. Transport of ions to generate epithelial rehydration (TIGER)-1 was a randomized trial conducted to evaluate the safety and efficacy of denufosol versus placebo in patients with cystic fibrosis with mild impairment in lung function. The trial met its primary end point at 24 weeks, but a subsequent trial did not show a sustained effect of denufosol at 48 weeks. By using the 48-week data, we characterized resource use, direct medical costs, indirect costs, and utility estimates. Data on medications, outpatient and emergency visits, hospital admissions, tests, procedures, and home nursing were captured

Safety and tolerability of denufosol tetrasodium inhalation solution, a novel P2Y2 receptor agonist: results of a phase 1/phase 2 multicenter study in mild to moderate cystic fibrosis. Denufosol tetrasodium (INS37217) is a selective P2Y(2) agonist that stimulates ciliary beat frequency and Cl(-) secretion in normal and cystic fibrosis (CF) airway epithelia, and is being investigated as an inhaled treatment for CF. The Cl(-) secretory response is mediated via a non-CFTR pathway, and the driving force for Cl(-) secretion is enhanced by the effect of P2Y(2) activation to also inhibit epithelial Na(+) transport. Denufosol is metabolically more stable and better tolerated, and may enhance mucociliary clearance for a longer period of time than previously investigated P2Y(2) agonists. The goal

Experience using centralized spirometry in the phase 2 randomized, placebo-controlled, double-blind trial of denufosol in patients with mild to moderate cystic fibrosis. Centralized spirometry may significantly improve quality of spirometry and reduce variability of this outcome measure in clinical trials in cystic fibrosis (CF). Spirometry was performed during the phase 2 randomized, placebo -controlled, double-blind clinical trial of denufosol in patients with mild to moderate CF using American Thoracic Society guidelines. Uniform spirometers were used with electronic data transmission of all the data to a reading center. Spirometry was evaluated for quality by a central reader based on start of test, cough during the test, and evidence of a plateau. A total of 1418 spirometry values were

Phase 2 randomized safety and efficacy trial of nebulized denufosol tetrasodium in cystic fibrosis. Denufosol tetrasodium is a selective P2Y(2) agonist that enhances mucosal hydration and mucus clearance by activating Cl(-) secretion and inhibiting epithelial Na(+) transport through a non-cystic fibrosis transmembrane conductance regulator mechanism in the lung. To examine the safety and efficacy of 28 days of treatment with denufosol compared with placebo in patients with mild cystic fibrosis. The study was a randomized, double-blind, multi-center, 28-day, phase 2 clinical trial of denufosol tetrasodium inhalation solution (20, 40, or 60 mg) versus placebo (normal saline). Patients with screening FEV(1) >or= 75% of predicted normal value and not treated with inhaled antibiotics

Denufosol: A review of studies with inhaled P2Y(2) agonists that led to Phase 3. Among the most promising of the new therapies being developed for the treatment of Cystic Fibrosis (CF) are those targeted at increasing mucosal hydration on the surface of the airways. One of these therapies, P2Y(2) receptor agonists, bypasses the defective CFTR chloride channel, and activates an alternative chloride channel. This activation results in an increase in airway surface epithelial hydration, and through these actions and effects on cilia beat frequency, increases mucociliary clearance. The pharmacology of P2Y(2) agonists has been confirmed in several preclinical and clinical studies. Denufosol tetrasodium is a novel second-generation, metabolically stable, selective P2Y(2) receptor agonist

Nucleotide receptors as targets in the pharmacological enhancement of dermal wound healing With a growing interest of the involvement of extracellular nucleotides in both normal physiology and pathology, it has become evident that P2 receptor agonists and antagonists may have therapeutic potential. The P2Y2 receptor agonists (diquafosol tetrasodium and denufosol tetrasodium) are in the phase 3

of exacerbations but there is insufficient evidence to know if it is more or less effective than other similar medications.[98] Dornase alpha may improve lung function, however there is no strong evidence that it is better than other hyperosmolar therapies.[98]Denufosol, an investigational drug, opens an alternative chloride channel, helping to liquefy mucus.[99] Whether inhaled corticosteroids are useful

Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment - Full Text View - ClinicalTrials.gov Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort. Hide glossary GlossaryStudy record managers: refer to the Data Element Definitions if submitting studies (100).Please remove one or more studies before adding more. Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov

fibrosis (CF) lung disease. Study drug will be administered through a nebulizer (a device that delivers medication as a mist by breathing it in).Condition or disease Intervention/treatment Phase Cystic Fibrosis Drug: denufosol tetrasodium (INS37217) Phase 2 Detailed Description: The purpose of this study is to: * assess the safety and efficacy of multiple dose Therapeutics Development Network and the Inspire 08-103 Working Group. Phase 2 randomized safety and efficacy trial of nebulized denufosol tetrasodium in cystic fibrosis. Am J Respir Crit Care Med. 2007 Aug 15;176(4):362-9. Epub 2007 Apr 19. Responsible Party: Merck Sharp & Dohme LLC ClinicalTrials.gov Identifier: NCT00056147 Other Study ID Numbers: 08

Eligibility Criteria Contacts and Locations More Information Brief Summary: The purpose of this study is to determine whether denufosol tetrasodium (INS37217) Intravitreal Injection is well tolerated and has the potential to treat uveitis associated macular edema.Condition or disease Intervention/treatment Phase Cystoid Macular Edema Uveitis Drug: denufosol tetrasodium (INS37217) Intravitreal Injection Phase 2 Detailed Description: Denufosol tetrasodium (INS37217) Intravitreal Injection may provide clinical benefit in treatment of uveitis associated macular edema (UME) by reducing retinal thickness as measured by OCT and possibly enabling recovery of vision loss associated with UME. Denufosol tetrasodium may also reverse

Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease - Full Text View - ClinicalTrials.gov Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort. Hide glossary GlossaryStudy record managers: refer to the Data Element Definitions if submitting registration studies (100).Please remove one or more studies before adding more. Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov

and Locations More Information Brief Summary: The purpose of this study is to investigate the safety and effectiveness of two dose strengths of study drug compared to placebo in pediatric patients with cystic fibrosis (CF).Condition or disease Intervention/treatment Phase Cystic Fibrosis Drug: denufosol tetrasodium (INS37217) Phase 2 Study Design Go to Top of Page Official Title: A Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Pediatric Patients With Cystic Fibrosis Lung Disease Study Start Date : August 2005

A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema - Full Text View - ClinicalTrials.gov Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort. Hide glossary GlossaryStudy record Save this study WarningYou have reached the maximum number of saved studies (100).Please remove one or more studies before adding more. A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been

Drug: denufosol tetrasodium (INS37217) Intravitreal Injection Phase 1 Study Design Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Study Type : Interventional (Clinical Trial

Eligibility Criteria Contacts and Locations More Information Brief Summary: The purpose of this trial is to characterize the pharmacokinetics of INS37217 following intravenous administration.Condition or disease Intervention/treatment Phase Healthy Drug: denufosol tetrasodium (INS37217) Phase 1 Study Design Go to Top of Page Study Description Study Design

Drug: denufosol tetrasodium (INS37217) Phase 1 Study Design Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Study Type : Interventional (Clinical Trial

fibrosisCondition or disease Intervention/treatment Phase Cystic Fibrosis Drug: denufosol tetrasodium (INS37217) Inhalation Solution Phase 1 Phase 2 Study Design Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Study Type Therapeutics Development Network. Safety and tolerability of denufosol tetrasodium inhalation solution, a novel P2Y2 receptor agonist: results of a phase 1/phase 2 multicenter study in mild to moderate cystic fibrosis. Pediatr Pulmonol. 2005 Apr;39(4):339-48. Responsible Party: Merck Sharp & Dohme LLC ClinicalTrials.gov Identifier: NCT00034515 Other Study ID

Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease