Cystic Fibrosis / Bronchiectasis

  1. VX16-659-101: A study evaluating the safety and efficacy of VX-659 combination therapy in subjects aged 18 years and older with cystic fibrosis (CF). This is a phase 2, randomized, double-blind, controlled study designed to evaluate the safety and efficacy of VX-659 in triple combination with Tezacaftor and Ivacaftor in subjects with CF who are homozygous for the F508del mutation or heterozygous for the F508del with a second allele carrying a minimal function (MF) mutation that is not expected to respond to Tezacaftor, Ivacaftor, and Tezacaftor/Ivacaftor.
    [Not yet submitted to Clinicaltrials.gov]
    https://clinicaltrials.gov/ct2/show/NCT03224351
  2. VX14-661-110: A Study to Evaluate the Safety and Efficacy of Long Term Treatment with VX-661 in Combination with Ivacaftor in Subjects with Cystic Fibrosis Who Have an F508del-CFTR Mutation. This is a Phase 3, multicenter, open-label, rollover study in subjects with CF who are homozygous or heterozygous (one or two copies) for the F508del-CFTR mutation. The study is designed to evaluate the safety and efficacy of long term treatment of VX-661 in combination with Ivacaftor. (Vertex Pharmaceuticals)
    [ClinicalTrials.gov Identifier: NCT02565914]
    https://clinicaltrials.gov/ct2/show/NCT02565914?term=NCT02565914&rank=1
  3. VX15-440-101: A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects with Cystic Fibrosis. This is a Phase 2, randomized, double-blind, placebo multicenter study to evaluate the safety, tolerability, and efficacy of VX-440 in dual and triple combination with Tezacaftor (VX-661) and Ivacaftor (VX-770) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation.(Vertex Pharmaceuticals).
    [ClinicalTrials.gov Identifier: NCT02951182]
  4. VX16-440-102: A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects with Cystic Fibrosis. This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of VX-440 in combination with Tezacaftor/Ivacaftor in subjects with Cystic Fibrosis who are heterozygous for F508del and a minimal function mutation (F508del/MF). This is triple combination therapy. (Vertex Pharmaceuticals)
    [Not yet submitted to Clinicaltrials.gov]
  5. VX16-440-105: A Study to Evaluate the Safety and Efficacy of Long-term VX-440 Combination Therapy with Cystic Fibrosis. This is a Phase 3, open-label study to evaluate the safety and efficacy of long-term VX-440 combination therapy in subjects with Cystic Fibrosis who are homozygous or who are heterozygous for F508del and a minimal function mutation (F508del/MF). Subjects who enroll in VX16-440-102 will be invited to enroll in this study.(Vertex Pharmaceuticals)
    [Not yet submitted to Clinicaltrials.gov]
  6. NTM PREDICT Trial: Prospective Evaluation of NTM Disease In Cystic Fibrosis. The study is observational in nature, and is designed to advance understanding of nontuberculous mycobacteria (NTM) infection and facilitate the decision making process regarding treatment. (Cystic Fibrosis Foundation).
    [ClinicalTrials.gov Identifier: NCT02073409]
    https://clinicaltrials.gov/ct2/show/NCT02073409?term=NCT02073409&rank=1
  7. NTM PATIENCE Trial: Prospective Algorithm for Treatment of NTM in Cystic Fibrosis. This trial tests the feasibility of a standardized treatment algorithm for confirmed infection with either M. avium complex or the M. abscessus complex. (Cystic Fibrosis Foundation).
    [ClinicalTrials.gov identifier NCT02419989]
    https://clinicaltrials.gov/ct2/show/NCT02419989?term=NCT02419989&rank=1
  8. EMPIRE study: A Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety and tolerability of CTX-4430 (an oral anti-inflammatory drug) administered orally once-daily for 48 Weeks in adult patients with cystic fibrosis. (Sponsor Celtaxys).
    [Clinical trials.gov identifier: NCT02443688]
    https://clinicaltrials.gov/ct2/show/NCT02443688?term=NCT02443688&rank=1
  9. STOP-2--- Standardized Treatment of Pulmonary Exacerbations II: Identification of an optimal IV antibiotic treatment duration has the potential to improve overall pulmonary exacerbation treatment outcomes and at the same time reduce toxicity and treatment burden associated with overtreatment for pulmonary exacerbations. Subjects with an early response to treatment are randomized to receive 10 vs. 14 days of therapy; those with a delayed response are randomized to receive 14 vs. 21 days of therapy. (Cystic Fibrosis Foundation).
    [Clinicaltrials.gov identifier: NCT02781610]
    https://clinicaltrials.gov/ct2/show/NCT02781610?term=STOP-2&cond=Cystic+Fibrosis&rank=1
  10. TEACH--- Testing the Effect of Adding Chronic Azithromycin to Inhaled Tobramycin. A randomized, placebo-controlled, double-blinded trial of azithromycin 500mg thrice weekly vs. placebo in combination with inhaled tobramycin. The purpose of this study is to test whether adding the medication azithromycin to tobramycin regimens alters effectiveness of in tobramycin.
    [Clinicaltrials.gov identifier: NCT02677701]
    https://clinicaltrials.gov/ct2/show/NCT02677701?term=TEACH&cond=Cystic+Fibrosis&draw=1&rank=1
  11. SAV005-04-- A Phase III, randomized, double-blind, placebo-controlled study of AeroVanc for the treatment of persistent methicillin-resistant Staphylococcus aureus lung infection in cystic fibrosis patients.AeroVanc is a novel dry powder formulation of vancomycin in a reloadable, capsule inhaler, intended for the treatment of MRSA lung infection in CF patients. (Savara Pharmaceuticals).
    [Clinicaltrials.gov identifier: NCT03181932].
    https://clinicaltrials.gov/ct2/show/NCT03181932?term=SAV005-04&cond=Cystic+Fibrosis&rank=1
  12. CQBW276X2201--- A randomized, double blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of inhaled QBW276 in patients with cystic fibrosis. CQBW276X2201is a potent inhaled sodium channel (ENaC) inhibitor. A therapy designed to improve the hydration of respiratory secretions and possibly lead to enhancement of clearance of respiratory secretions, thereby reducing the frequency of respiratory infections and slowing the decline in lung function.(Novartis).
    [Clinicaltrials.gov identifier: NCT02566044].
    https://clinicaltrials.gov/ct2/show/NCT02566044?term=Novartis+CQBW276X2201&cond=Cystic+Fibrosis&rank=1

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