299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05663255 (ClinicalTrials.gov) | March 1, 2023 | 15/12/2022 | Effectiveness of CFTR Modulators According to Co-therapy | Is Effectiveness of CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Modulators Impacted by Co-therapy? A Population-based Comparative Effectiveness Study Using Data From French Cystic Fibrosis Registry Linked to French National Healthcare Insurance Database | Cystic Fibrosis | Drug: Discontinuation of respiratory co-therapy (azithromycin, RhDNase, or inhaled antibiotics) | Hospices Civils de Lyon | NULL | Not yet recruiting | 6 Years | N/A | All | 1990 | NULL | |
| 2 | NCT05523180 (ClinicalTrials.gov) | September 1, 2022 | 22/8/2022 | A Study to Evaluate the Effect of Probiotic Supplement on Quality of Life | A Prospective, Randomized, Double-blinded, Placebo-controlled Study Evaluating the Safety and Impact of resB® Lung Support on Quality of Life in Adult Volunteers With Chronic Obstructive Pulmonary Disease or Non-cystic Fibrosis Bronchiectasis | Chronic Obstructive Pulmonary Disease;Non-cystic Fibrosis Bronchiectasis | Dietary Supplement: Probiotic;Other: Placebo | ResBiotic Nutrition, Inc. | Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | Recruiting | 18 Years | 80 Years | All | 50 | N/A | United States |
| 3 | NCT04056702 (ClinicalTrials.gov) | September 5, 2019 | 27/7/2019 | Impact of Triple Combination CFTR Therapy on Sinus Disease. | Impact of Elexacaftor-tezacaftor-ivacaftor Triple Combination CFTR Therapy on Sinus Disease: Quantitative Sinus Computed Tomography, Patient Reported Outcomes and Cellular and Molecular Changes | Cystic Fibrosis | Drug: Elexacaftor-tezacaftor-ivacaftor exposure | Jennifer Taylor-Cousar | Cystic Fibrosis Foundation | Recruiting | 18 Years | 89 Years | All | 31 | United States | |
| 4 | NCT03795363 (ClinicalTrials.gov) | April 10, 2019 | 28/12/2018 | Orkambi Treatment in 2 to 5 Year Old Children With CF | Nutritional Impact of Orkambi Treatment in 2 to 5 Year Old Children Homozygous for F508del Mutations | Cystic Fibrosis | Drug: Orkambi | Children's Hospital of Philadelphia | Vertex Pharmaceuticals Incorporated | Completed | 2 Years | 5 Years | All | 28 | United States | |
| 5 | NCT03783286 (ClinicalTrials.gov) | February 6, 2019 | 18/12/2018 | Ivacaftor Treatment in 4 Month to 2 Year Old CF Subjects | Nutritional Impact of Ivacaftor Treatment in 4 Month to 2 Year Old Children With CF Gating Mutations | Cystic Fibrosis | Drug: Ivacaftor | Children's Hospital of Philadelphia | Vertex Pharmaceuticals Incorporated | Completed | 4 Months | 2 Years | All | 15 | United States | |
| 6 | NCT03625466 (ClinicalTrials.gov) | August 10, 2018 | 7/8/2018 | A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | An Exploratory Phase 2, 2-part, Randomized, Double-blind, Placebo-controlled Study With a Long-term, Open-label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | Cystic Fibrosis | Drug: LUM;Drug: IVA;Drug: Matched Placebos | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 2 Years | 5 Years | All | 51 | Phase 2 | Germany |
| 7 | EUCTR2017-003761-99-DE (EUCTR) | 27/06/2018 | 19/02/2018 | A Study of the Effects of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | An Exploratory Phase 2, 2-part, Randomized, Double blind, Placebo controlled Study With a Long term, Open label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor / ivacaftor Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Product Name: lumacaftor / ivacaftor Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Orkambi 100 mg/125 mg film-coated tablets Product Name: LUM/IVA fixed-dose combination INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Other descriptive name: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Germany | ||
| 8 | NCT03492567 (ClinicalTrials.gov) | April 25, 2018 | 3/4/2018 | Study of Circulating Blood Cell Monocytes as Predictive Biomarker of Bone Cystic Fibrosis Disease. Impact of CFTR Correctors. | Study of Circulating Monocytes as Predictive Biomarker of Osteoclastogenesis in Cystic Fibrosis-related Bone Loss. Impact of CFTR Correctors. | Cystic Fibrosis | Biological: Blood test | Assistance Publique - Hôpitaux de Paris | Vaincre la Mucoviscidose | Completed | 18 Years | N/A | All | 25 | N/A | France |
| 9 | NCT02734810 (ClinicalTrials.gov) | June 2016 | 6/4/2016 | SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis | A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | Exocrine Pancreatic Insufficiency;Cystic Fibrosis | Drug: Liprotamase Powder for Oral Solution | Anthera Pharmaceuticals | NULL | Completed | N/A | N/A | All | 15 | Phase 3 | United States |
| 10 | EUCTR2011-000801-39-ES (EUCTR) | 25/07/2014 | 25/04/2014 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens? eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Belgium;Spain;Ireland;Austria;Germany;Italy;Sweden | ||
| 11 | EUCTR2011-000801-39-AT (EUCTR) | 11/06/2014 | 24/04/2014 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 12 | EUCTR2011-000801-39-HU (EUCTR) | 22/05/2014 | 03/04/2014 | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 13 | NCT02048592 (ClinicalTrials.gov) | September 2013 | 16/12/2013 | Impact of Immunonutrition on the Patients With Cystic Fibrosis | Impact of Immunonutrition on the Patients With Cystic Fibrosis | Cystic Fibrosis;Malnutrition;Oxidative Stress | Dietary Supplement: Impact-Nutridrink;Dietary Supplement: Nutridrink-Impact | University Hospital, Motol | NULL | Recruiting | 18 Years | 40 Years | Both | 30 | Phase 4 | Czech Republic |
| 14 | EUCTR2011-000801-39-IE (EUCTR) | 07/05/2013 | 12/02/2013 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 15 | EUCTR2011-000801-39-IT (EUCTR) | 20/06/2012 | 21/06/2012 | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT -PsAer-IgY | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT -PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially effects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbility and mortality. PA infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | MUKOVISZIDOSE E.V. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 16 | EUCTR2011-000801-39-BE (EUCTR) | 26/04/2012 | 09/01/2012 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 17 | EUCTR2011-000801-39-SE (EUCTR) | 08/02/2012 | 13/12/2011 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 14.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 18 | EUCTR2011-000801-39-DE (EUCTR) | 31/08/2011 | 04/04/2011 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 17.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 19 | NCT01031706 (ClinicalTrials.gov) | September 2009 | 11/12/2009 | Effect of Hypertonic Saline on Mucus Clearance in Children Ages 5-12 With Cystic Fibrosis | Sustained Impact of Hypertonic Saline on Mucociliary Clearance in Young Children With Cystic Fibrosis | Cystic Fibrosis | Drug: Hypertonic Saline;Drug: Placebo | University of North Carolina, Chapel Hill | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 5 Years | 12 Years | All | 23 | N/A | United States |