Cystic Fibrosis
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CLINICAL_TRIALS trial_result · 2016-06-09Clinical Trial Update: Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis Patients [Phase 2]
This document reports the completion of a Phase II trial evaluating the safety and efficacy of inhaled alpha-1 antitrypsin in cystic fibrosi…
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FDA approval · 2016-06-08FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approves a supplemental application for KALYDECO (ivacaftor) from Vertex Pharmaceuticals Incorporated.
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CLINICAL_TRIALS trial_result · 2016-06-07Clinical Trial Update: Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis [Phase 1, Phase 2]
Phase 1/Phase 2 trial results evaluating the efficacy and tolerability of NM-BL in patients with exocrine pancreatic insufficiency due to cy…
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CLINICAL_TRIALS research · 2016-06-06Clinical Trial Update: Transition From Pediatric to Adult Cystic Fibrosis Care Center
This clinical trial update describes a study on transitioning pediatric cystic fibrosis patients to adult care at a French center; the curre…
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CLINICAL_TRIALS trial_result · 2016-06-03Clinical Trial Update: Evaluation of the Safety and Tolerability of Inhaled Nitric Oxide to Subjects With Cystic Fibrosis [Phase 1, Phase 2]
Phase 1/2 clinical trial evaluating the safety and tolerability of inhaled nitric oxide in subjects with cystic fibrosis has completed.
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CLINICAL_TRIALS trial_result · 2016-06-03Clinical Trial Update: A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis [Phase 2]
A Phase 2 short-term comparative trial evaluating Aerosure for airway clearance in cystic fibrosis has been terminated.
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CLINICAL_TRIALS trial_result · 2016-05-24Clinical Trial Update: Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI) [Phase 4]
Phase 4 trial comparing ease of use and microbial contamination of Tobramycin Inhalation Powder (TIP) versus Nebulised Tobramycin Inhalation…
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CLINICAL_TRIALS trial_result · 2016-05-23Clinical Trial Update: Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients [Phase 4]
Phase 4 clinical trial updating validation of usage instructions for TOBI Podhaler in cystic fibrosis; results posted in 2016.
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FDA label_change · 2016-05-20FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for KALYDECO (ivacaftor) from Vertex Pharmaceuticals Incorporated, resulting in a label change. The …
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FDA approval · 2016-05-18FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA has approved a supplemental application for ORKAMBI (lumacaftor and ivacaftor) from Vertex Pharmaceuticals Incorporated. The approval up…
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CLINICAL_TRIALS trial_result · 2016-05-17Clinical Trial Update: Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult Volunteers [Phase 1]
Phase 1 study evaluating safety, tolerability and pharmacokinetics of inhaled AIR DNAse in healthy adult volunteers is reported, sponsored b…
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FDA approval · 2016-05-16FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)
FDA approved a supplemental application for Pancreaze (pancrelipase) by VIVUS LLC, expanding labeling/indications related to exocrine pancre…
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CLINICAL_TRIALS trial_result · 2016-05-09Clinical Trial Update: Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF [Phase 3]
This entry reports the results of a Phase 3 trial evaluating aztreonam for inhalation solution (AZLI) given in a continuous alternating ther…
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CLINICAL_TRIALS trial_result · 2016-05-02Clinical Trial Update: Investigating Mucinase Activity in Airway Disease
A completed clinical study investigating mucinase activity in airway diseases including asthma and cystic fibrosis has concluded.
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CLINICAL_TRIALS research · 2016-05-02Clinical Trial Update: Blood Collection From Individuals With Lung Disease for Genetic Studies (Qatar)
A completed clinical trial update describing a genetic blood collection study from individuals with lung diseases in Qatar.
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FDA approval · 2016-04-29FDA Approved: TOBI — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for TOBI (tobramycin inhalation solution) from Viatris Specialty LLC. This action updates the produc…
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CLINICAL_TRIALS research · 2016-04-29Clinical Trial Update: Blood Collection From Individuals With Lung Disease for Genetic Studies
A completed clinical trial update describing blood collection from people with lung diseases for genetic studies to advance understanding of…
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CLINICAL_TRIALS research · 2016-04-28Clinical Trial Update: Registry Study on Cystic Fibrosis in Chinese Children
A registry study focusing on cystic fibrosis in Chinese children has been registered; the study status is NOT_YET_RECRUITING.
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CLINICAL_TRIALS trial_result · 2016-04-27Clinical Trial Update: Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years [Phase 3]
Phase 3 randomized trial in young children with cystic fibrosis evaluating treatment of early Pseudomonas aeruginosa lung infections; the st…
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CLINICAL_TRIALS research · 2016-04-19Clinical Trial Update: The iStep Study: Development and Validation of an Incremental Exercise Step Test for Children With Cystic Fibrosis [NA]
The iStep Study aims to develop and validate an incremental exercise step test for children with cystic fibrosis. The study status is comple…
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CLINICAL_TRIALS trial_result · 2016-04-12Clinical Trial Update: Muco Smartphone Exacerbation [EARLY_Phase 1]
This update reports the completed results of an early Phase 1 trial involving Muco Smartphone Exacerbation in cystic fibrosis, conducted by …
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CLINICAL_TRIALS research · 2016-04-12Clinical Trial Update: Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis [NA]
A clinical trial update evaluating a high-frequency digit triplet test in individuals with cystic fibrosis, with sensorineural hearing loss …
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CLINICAL_TRIALS trial_result · 2016-04-08Clinical Trial Update: FTIH - Single and Repeat Oral Doses of FDL169 in Healthy Volunteers [Phase 1]
Phase 1 study evaluating safety, tolerability, and pharmacokinetics of single and repeat oral doses of FDL169 in healthy volunteers has been…
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FDA approval · 2016-04-06FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for ORKAMBI (lumacaftor and ivacaftor) filed by Vertex Pharmaceuticals Incorporated.
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CLINICAL_TRIALS trial_result · 2016-03-31Clinical Trial Update: Pharmacokinetics of FDL169 in Healthy Female Subjects [Phase 1]
This Phase 1 pharmacokinetic study of FDL169 in healthy female subjects has completed.