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

  
13 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02088216
(ClinicalTrials.gov)
April 1, 20145/3/2014Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of BronchiectaisisEffect of N-acetylcysteine on Exacerbations of Bronchiectasis (BENE): a Randomized Controlled TrialNon-Cystic Fibrosis BronchiectasisDrug: N-acetylcysteine;Other: On-demand treatmentQilu Hospital of Shandong UniversityNULLCompleted18 Years80 YearsAll161N/AChina
2EUCTR2010-018454-13-DK
(EUCTR)
27/10/201013/08/2010A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® Cystic fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Laboratoires SMB S.A.NULLNot RecruitingFemale: yes
Male: yes
552Phase 3France;Czech Republic;Hungary;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
3EUCTR2010-018454-13-ES
(EUCTR)
06/09/201031/05/2010A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®Estudio de fase III multicéntrico, doble ciego, aleatorizado y controlado con placebo de la incidencia de recurrencia de las exacerbaciones pulmonares en pacientes con fibrosis quística utilizando dos dosis diferentes de Nacystelyn® inhaladoA Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®Estudio de fase III multicéntrico, doble ciego, aleatorizado y controlado con placebo de la incidencia de recurrencia de las exacerbaciones pulmonares en pacientes con fibrosis quística utilizando dos dosis diferentes de Nacystelyn® inhalado Cystic fibrosisFibrosis quistica
MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine- N-acetylcysteinate
Other descriptive name: Nacystelyn®
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine- N-acetylcysteinate
Other descriptive name: Nacystelyn®
Laboratoires SMB S.A.NULLNot RecruitingFemale: yes
Male: yes
552Phase 3France;Czech Republic;Hungary;Belgium;Spain;Denmark;Germany;United Kingdom;Italy
4EUCTR2010-018454-13-GB
(EUCTR)
01/09/201018/06/2010A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® Cystic fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Laboratoires SMB S.A.NULLNot RecruitingFemale: yes
Male: yes
552Phase 3Hungary;Czech Republic;Germany;United Kingdom;France;Spain;Italy
5EUCTR2010-018454-13-DE
(EUCTR)
31/08/201021/05/2010A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® Cystic fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Laboratoires SMB S.A.NULLNot RecruitingFemale: yes
Male: yes
552Phase 3Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy
6EUCTR2010-018454-13-CZ
(EUCTR)
27/08/201021/06/2010A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® Cystic fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Laboratoires SMB S.A.NULLNot RecruitingFemale: yes
Male: yes
552Phase 3Hungary;United Kingdom;Germany;Czech Republic;France;Spain;Italy
7EUCTR2010-018454-13-HU
(EUCTR)
17/08/201017/06/2010A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® Cystic fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Laboratoires SMB S.A.NULLNot RecruitingFemale: yes
Male: yes
552Phase 3Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy
8EUCTR2010-018454-13-FR
(EUCTR)
10/08/201028/05/2010A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® Cystic fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Laboratoires SMB S.A.NULLNot RecruitingFemale: yes
Male: yes
552Phase 3France;Czech Republic;Hungary;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
9EUCTR2010-018454-13-IT
(EUCTR)
15/07/201015/06/2010A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn - NDA Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn - ND Cystic fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10011762
Product Name: Nacystelyn
Product Code: NAL
INN or Proposed INN: L-Lysine N acetylcysteinate
Product Name: Nacystelyn
Product Code: NAL
INN or Proposed INN: L-Lysine N-acetylcysteinate
LABORATOIRES SMB S.A.NULLNot RecruitingFemale: yes
Male: yes
552Phase 3Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy
10EUCTR2007-001401-15-DK
(EUCTR)
21/05/201014/04/2010Treatment of patients with cystic fibrosis with N-acetylcysteineTreatment of patients with cystic fibrosis with N-acetylcysteine Patients with cystic fibrosis and chronic Pseudomonas lung infection
MedDRA version: 12.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: ACC600Tabs
Product Name: N-acetylcystein
Product Code: R05C B01
INN or Proposed INN: ACETYLCYSTEINE
RigshospitaletNULLNot RecruitingFemale: yes
Male: yes
Phase 4Denmark
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
13NCT00809094
(ClinicalTrials.gov)
November 200815/12/2008NAC Phase IIB: A Multi-Center, Phase IIB, Randomized, Placebo-controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis PatientsA Multi-Center, Phase IIB, Randomized, Placebo-controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis PatientsCystic FibrosisDrug: N-acetylcysteine (NAC);Drug: PlaceboStanford UniversityCystic Fibrosis Foundation TherapeuticsCompleted7 YearsN/AAll70Phase 2United States