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

  
19 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2016-000398-19-BE
(EUCTR)
08/03/201609/02/2016Pilot study: pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem in blood and sputum of cystic fibrosis patients.Pilot study: pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem in blood and sputum of cystic fibrosis patients. - pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem Cystic fibrosis;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Trade Name: Meropenem Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie
INN or Proposed INN: Meropenem Fresenius Kabi
Other descriptive name: MEROPENEM TRIHYDRATE
Trade Name: Ceftazidim Fresenius Kabi 2000 mg poeder voor oplossing voor injectie of infusie
INN or Proposed INN: Ceftazidim Fresenius Kabi
Other descriptive name: CEFTAZIDIME PENTAHYDRATE
Trade Name: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie
INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie
Other descriptive name: PIPERACILLIN SODIUM
INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie
Other descriptive name: TAZOBACTAM SODIUM
Trade Name: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie
INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie
Other descriptive name: PIPERACILLIN SODIUM
INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie
Other descriptive name: TAZOBACTAM SODIUM
Ghent UniversityNULLNot RecruitingFemale: yes
Male: yes
45Phase 4Belgium
2NCT02840136
(ClinicalTrials.gov)
February 201618/7/2016LC-MS/MS Based Method Development for the Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis PatientsOptimisation, Valorisation and Application of UPLC-MS/MS Based Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients - Part 3: Non-blank Sputum Samples for Method Optimisation and ValidationCystic FibrosisDrug: Piperacillin-tazobactam combination product;Drug: Meropenem;Drug: CeftazidimeUniversity GhentKing Baudouin Foundation;Belgische Vereniging voor Strijd tegen MucoviscidoseSuspended12 YearsN/AAll40N/ABelgium
3NCT02589444
(ClinicalTrials.gov)
December 201520/10/2015Vitamin D and Microbiota in Cystic FibrosisPilot Study Evaluating the Role of Vitamin D Repletion on Gut and Lung Microbiota in Cystic FibrosisVitamin D Deficiency;Cystic FibrosisDietary Supplement: High-Dose Vitamin D3;Other: Stool Sample;Other: Sputum Sample;Other: Sham Comparator;Procedure: Blood drawEmory UniversityNULLCompleted18 YearsN/AAll41N/AUnited States
4EUCTR2015-003662-87-DK
(EUCTR)
13/11/201522/09/2015Pseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of lifePseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of life - Pseudomonas, Tazocin or Colistin Chronic pulmonary disease patients, except cystic fibrosis patients, with confirmed pulmonary infection by sputum sample positive for Pseudomonas Aeruginosa.
MedDRA version: 18.1;Level: LLT;Classification code 10051190;Term: Pneumonia Pseudomonas aeruginosa;System Organ Class: 100000004862
MedDRA version: 18.1;Classification code 10050700;Term: Chronic respiratory disease NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: colistimethate sodium (promixin)
INN or Proposed INN: COLISTIMETHATE SODIUM
Trade Name: Piperacillin with Tazobactam (tazocin)
INN or Proposed INN: PIPERACILLIN
Other descriptive name: PIPERACILLIN
INN or Proposed INN: TAZOBACTAM
Other descriptive name: TAZOBACTAM
Aarhus University Hospital, Department of Respiratory MedicineNULLNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
5NCT02444234
(ClinicalTrials.gov)
July 20156/5/2015Pharmacokinetics of Tedizolid Phosphate in Cystic FibrosisSteady-State Pharmacokinetics of Tedizolid in Plasma and Sputum of Patients With Cystic FibrosisCystic FibrosisDrug: Tedizolid PO;Drug: Tedizolid IVUniversity of Southern CaliforniaMerck Sharp & Dohme Corp.Completed18 YearsN/AAll11Phase 4United States
6EUCTR2013-004987-80-BE
(EUCTR)
28/08/201418/02/2014Colistin dosage through blood samples and sputum in Cystic Fibrosis (CF) populationColistin use in Cystic Fibrosis patients: pharmacokinetic studies (intravenous administration) in relation with pharmacodynamics, tolerance profile and risk of selection of resistance. Colistin use in Cystic Fibrosis patients
MedDRA version: 16.1;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]
Trade Name: COLISTINEB 2MUI
INN or Proposed INN: Colistineb
Other descriptive name: COLISTIMETHATE SODIUM (A COMPONENT)
CUB - Hôpital ErasmeNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Belgium
7NCT01576315
(ClinicalTrials.gov)
June 201429/3/2012ATCF (Azole Therapy in Cystic Fibrosis)Efficacy of Itraconazole and of Voriconazole in Patients With Cystic Fibrosis and Presenting With Persistent Positive Sputums for Aspergillus.Cystic Fibrosis;Aspergillus InfectionsDrug: Itraconazole/voriconazoleRennes University HospitalNULLCompleted12 YearsN/ABoth11Phase 2France;United Kingdom
8EUCTR2011-005799-41-GB
(EUCTR)
04/10/201221/08/2012Azole Therapy in Cystic Fibrosis (ATCF)Azole Therapy in Cystic Fibrosis (ATCF) : Efficacy of itraconazole and ofvoriconazole in patients with cystic fibrosis and presenting withpersistent positive sputums for Aspergillus - Azole Therapy in Cystic Fibrosis (ATCF) Cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: HLT;Classification code 10003486;Term: Aspergillus infections;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: SPORANOX
Product Name: Sporanox 10 mg/ml Oral Solution
INN or Proposed INN: ITRACONAZOLE
Other descriptive name: SPORANOX
Trade Name: V-Fend
Product Name: VFEND 40 mg/ml powder for oral suspension
INN or Proposed INN: voriconazole
Other descriptive name: Vfend
CHU de Rennes (Rennes University Hospital Centre)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150United Kingdom
9NCT01201434
(ClinicalTrials.gov)
October 201031/8/2010Effect of Probiotics on Sputum Inflammation and Pulmonary Infections in Patients With Cystic FibrosisThe Effect of Probiotics on Sputum Bacteria, Sputum Inflammation, and Pulmonary Infections in Patients With Cystic Fibrosis: A Double-blind Placebo-controlled TrialCystic FibrosisDietary Supplement: Bio-25 probioticSheba Medical CenterNULLTerminated5 Years40 YearsBoth12N/ANULL
10NCT02198079
(ClinicalTrials.gov)
March 201021/2/2014A Prospective, Multicenter, Collaborative Study to Determine the Prevalence of Nontuberculous Mycobacteria (NTM) in Pediatric Patients With Cystic Fibrosis in FloridaA Prospective, Multicenter, Collaborative Study to Determine the Prevalence of Nontuberculous Mycobacteria (NTM) in Pediatric Patients With Cystic Fibrosis in FloridaCystic Fibrosis;PediatricsBiological: SputumUniversity of MiamiUniversity of FloridaCompletedN/A18 YearsBoth85N/AUnited States
11NCT00996424
(ClinicalTrials.gov)
January 201015/10/2009The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung FunctionThe Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function.Cystic FibrosisDrug: Acetylcysteine;Drug: normal salineUniversity Hospital, GhentBVSMTerminated6 Years64 YearsBoth19Phase 4Belgium
12EUCTR2008-008317-20-BE
(EUCTR)
13/11/200921/09/2009The effect of inhaled N-Acetylcysteine compared to normal saline on sputum rheology and lung functionThe effect of inhaled N-Acetylcysteine compared to normal saline on sputum rheology and lung function Cystic Fibrosis
MedDRA version: 12.0;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Lysomucil 10 %
Product Name: N-acetylcysteine
INN or Proposed INN: Acetylcysteine
University Hospital GhentNULLNot RecruitingFemale: yes
Male: yes
Belgium
13NCT00843817
(ClinicalTrials.gov)
April 200912/2/2009RhDNase and Biodistribution of PMN Serine Proteases in Cystic Fibrosis SputumRhDNase Effect on Biodistribution of PMN Serine Proteases in Cystic Fibrosis SputumCystic FibrosisDrug: PulmozymeUniversity Hospital, ToursNULLCompleted18 YearsN/AAll15Phase 4France
14NCT01112059
(ClinicalTrials.gov)
November 200820/4/2010Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) PatientsA Randomized Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult CF Patients Hospitalized for Pulmonary ExacerbationsCystic FibrosisDrug: Doxycycline;Other: placeboUniversity of Alabama at BirminghamCystic Fibrosis Foundation TherapeuticsCompleted19 YearsN/AAll40N/AUnited States
15NCT01323101
(ClinicalTrials.gov)
April 200815/2/2011Doxycycline Effects on Inflammation in Cystic FibrosisEffect of Doxycycline on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Patients With Cystic Fibrosis.Cystic FibrosisDrug: Doxycycline;Other: No doxycyclineUniversity of Southern CaliforniaNULLCompleted18 YearsN/AAll21Phase 4United States
16NCT00719381
(ClinicalTrials.gov)
January 200817/7/2008Effect of Pioglitazone on Inflammation in Cystic FibrosisEffect of Pioglitazone on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Cystic FibrosisCystic FibrosisDrug: PioglitazonePaul BeringerNULLCompleted18 YearsN/ABoth24Phase 1United States
17EUCTR2007-002707-40-BE
(EUCTR)
28/06/200704/06/2007The effect of inhalation with hypertonic saline (7%) on lung function and sputum rheology in Cystic Fibrosis patients The effect of inhalation with hypertonic saline (7%) on lung function and sputum rheology in Cystic Fibrosis patients Mucoviscidose
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Hypertonic saline solution
INN or Proposed INN: Sodium Chloride
Product Name: Normal saline solution
INN or Proposed INN: Sodium Chloride
University Hospital GhentNULLNot RecruitingFemale: yes
Male: yes
60Belgium
18NCT00721071
(ClinicalTrials.gov)
December 200621/7/2008Utility of Induced Sputum Using Hypertonic Saline to Evaluate Infection and Inflammation in Cystic FibrosisDiagnostic Utility of Induced Sputum Using Hypertonic Saline to Evaluate Airway Infection and Inflammation in Cystic FibrosisCystic FibrosisDrug: Hypertonic SalineThe Hospital for Sick ChildrenNULLCompleted6 Years18 YearsBoth95Phase 2Canada
19NCT00219895
(ClinicalTrials.gov)
August 200416/9/2005Assessment of Inflammatory Mediators (AIM)Assessment of Induced Sputum as a Tool to Evaluate Anti-Inflammatory Agents in Patients With Cystic FibrosisCystic FibrosisDrug: IbuprofenRamsey, Bonnie, MDCystic Fibrosis Foundation TherapeuticsCompleted10 YearsN/ABoth120N/AUnited States