Cystic Fibrosis
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CLINICAL_TRIALS research · 2011-05-13Clinical Trial Update: Amiloride Solution and Tobramycin Solution for Inhalation for the Eradication of Burkholderia Dolosa in Patients With Cystic Fibrosis [Phase 1]
A Phase 1 clinical trial evaluating inhaled amiloride and inhaled tobramycin for eradication of Burkholderia dolosa in cystic fibrosis patie…
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CLINICAL_TRIALS research · 2011-05-13Clinical Trial Update: Tissue Bank for Pulmonary Diseases
An update on a Tissue Bank for Pulmonary Diseases sponsored by Boston Children's Hospital, associated with Cystic Fibrosis. The trial status…
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CLINICAL_TRIALS research · 2011-05-13Clinical Trial Update: Microbial Community Composition and Dynamics in Lungs of Cystic Fibrosis Sibling Pairs
This entry reports on a completed clinical study from Boston Children's Hospital investigating the microbial community composition and dynam…
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CLINICAL_TRIALS trial_result · 2011-04-21Clinical Trial Update: International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa [Phase 3]
Phase 3 trial update for aztreonam for inhalation solution (Cayston) evaluating safety and efficacy in cystic fibrosis patients with Pseudom…
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CLINICAL_TRIALS research · 2011-04-18Clinical Trial Update: Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic Fibrosis [Phase 1, Phase 2]
A Phase 1/2 pharmacokinetic bioequivalence trial comparing Nebcinal inhalation (150 mg/3 mL) via Aeroneb Idehaler to Tobi (tobramycin 300 mg…
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CLINICAL_TRIALS trial_result · 2011-04-18Clinical Trial Update: Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis [NA]
Clinical trial update reporting short-term safety and efficacy results of lubiprostone in adults with cystic fibrosis, with constipation lis…
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CLINICAL_TRIALS trial_result · 2011-04-18Clinical Trial Update: Comparison of Antibiotics for Pseudomonas in Early CF [Phase 1]
Phase 1 trial comparing antibiotics for Pseudomonas infection in early cystic fibrosis has completed.
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CLINICAL_TRIALS trial_result · 2011-04-13Clinical Trial Update: Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis [Phase 2]
Phase 2 trial evaluating the safety and efficacy of a 12-week two-dose tiotropium Respimat regimen in cystic fibrosis.
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CLINICAL_TRIALS trial_result · 2011-03-30Clinical Trial Update: Phase I Study of Liposome-Mediated Gene Transfer in Patients With Cystic Fibrosis [Phase 1]
This is a completed Phase I clinical trial evaluating liposome-mediated gene transfer in patients with cystic fibrosis.
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CLINICAL_TRIALS research · 2011-03-30Clinical Trial Update: Study of Yoga as a Therapy for Cystic Fibrosis (CF) Patients [NA]
This entry reports on a study investigating yoga as a therapy for cystic fibrosis, with the trial status listed as unknown.
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CLINICAL_TRIALS trial_result · 2011-03-29Clinical Trial Update: Phase I Pilot Study of Gene Therapy for Cystic Fibrosis Using Cationic Liposome Mediated Gene Transfer [Phase 1]
Phase I pilot study evaluating cationic liposome–mediated gene transfer for cystic fibrosis; the trial has completed.
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CLINICAL_TRIALS trial_result · 2011-03-11Clinical Trial Update: Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA) [Phase 3]
Phase 3 clinical trial evaluating aztreonam for inhalation solution (AZLI) in cystic fibrosis patients with Pseudomonas aeruginosa completed…
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CLINICAL_TRIALS trial_result · 2011-03-11Clinical Trial Update: Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa [Phase 3]
Phase 3 study evaluating aztreonam for inhalation solution (AZLI) in cystic fibrosis patients with Pseudomonas aeruginosa has completed and …
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CLINICAL_TRIALS research · 2011-03-07Clinical Trial Update: Anti-inflammatory Pulmonal Therapy of Cystic Fibrosis (CF) Patients With Amitriptyline and Placebo [Phase 2]
A Phase 2 clinical trial is evaluating amitriptyline as an anti-inflammatory treatment in cystic fibrosis patients, with placebo control; cu…
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CLINICAL_TRIALS trial_result · 2011-02-16Clinical Trial Update: Evaluation of Bronchial Inflammation in Allergic Bronchopulmonary Aspergillosis (ABPA)
A completed clinical trial evaluating bronchial inflammation in Allergic bronchopulmonary aspergillosis (ABPA) in patients with cystic fibro…
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CLINICAL_TRIALS research · 2011-02-02Clinical Trial Update: Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® [NA]
This clinical trial update describes a pharmacokinetic bioequivalence study comparing Nebcinal inhalation therapy to Tobi in cystic fibrosis…
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CLINICAL_TRIALS trial_result · 2011-01-12Clinical Trial Update: Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects [Phase 1]
Phase 1 pharmacokinetic and safety study of VX-770 (ivacaftor) in subjects with moderate hepatic impairment and matched healthy controls has…
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CLINICAL_TRIALS trial_result · 2011-01-11Clinical Trial Update: Pharmacokinetic Study of Lansoprazole in Cystic Fibrosis [Phase 1]
Phase 1 pharmacokinetic study of lansoprazole in individuals with cystic fibrosis has completed.
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CLINICAL_TRIALS trial_result · 2010-12-20Clinical Trial Update: Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa [Phase 3]
A Phase 3 safety and efficacy trial of aztreonam for inhalation solution (AZLI) in cystic fibrosis patients with Pseudomonas aeruginosa comp…
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CLINICAL_TRIALS trial_result · 2010-12-09Clinical Trial Update: Study of VX-770 on Desipramine [Phase 1]
A Phase 1 trial evaluating the interaction between ivacaftor (VX-770) and desipramine in cystic fibrosis has completed.
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CLINICAL_TRIALS trial_result · 2010-12-01Clinical Trial Update: Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis [Phase 1, Phase 2]
Phase 1/2 trial assessing safety and tolerability of inhaled nitric oxide in cystic fibrosis patients; study completed with results posted i…
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CLINICAL_TRIALS trial_result · 2010-11-16Clinical Trial Update: A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC) [Phase 4]
A Phase 4 trial (TOPIC) examined the impact of Pulmozyme withdrawal on exercise tolerance in cystic fibrosis patients with severe lung disea…
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CLINICAL_TRIALS trial_result · 2010-11-11Clinical Trial Update: Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis [NA]
A clinical trial evaluating quadriceps muscle electrostimulation in patients with cystic fibrosis has been terminated.
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CLINICAL_TRIALS trial_result · 2010-10-11Clinical Trial Update: Effects of Vitamin D Supplementation on Lung Function in an Acute Pulmonary Exacerbation of Cystic Fibrosis [NA]
This clinical trial update reports on the completed study assessing the effect of vitamin D supplementation on lung function during acute pu…
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FDA approval · 2010-10-06FDA Approved: PULMOZYME — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for Pulmozyme (dornase alfa) from Genentech, Inc., under the original Biologics License Application.