299. 嚢胞性線維症 [臨床試験数:1,592,薬物数:1,539(DrugBank:255),標的遺伝子数:81,標的パスウェイ数:162

Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
35 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-001785-29-IE15/08/201610/05/2016Study of the effects of combined treatment with the CFTR corrector ivacaftor and IV antibiotics on infection in CF.Combined Effect of CFTR Modifiers and Intensive Antibiotic Treatment Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Kalydeco
INN or Proposed INN: IVACAFTOR
Trade Name: Ciprofloxacin
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE
Product Name: Flucloxicillin
INN or Proposed INN: FLUCLOXACILLIN SODIUM
Trade Name: Fortum
INN or Proposed INN: CEFTAZIDIME
Product Name: Tobramycin
INN or Proposed INN: TOBRAMYCIN SULFATE
Trade Name: Meropenem
INN or Proposed INN: Meropenem
Other descriptive name: MEROPENEM
Trade Name: Colistin
INN or Proposed INN: COLISTIMETHATE SODIUM
St. Vincent's University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Ireland
2EUCTR2013-004295-35-AT30/04/201402/04/2014Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept studyLung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study - LCI-OUT Chronic lung P. Aeruginosa Infection
MedDRA version: 16.1Level: PTClassification code 10061229Term: Lung infectionSystem Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler
Product Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler
INN or Proposed INN: aztreonam
Other descriptive name: AZTREONAM LYSINE
Trade Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel
Product Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel
INN or Proposed INN: COLISTIMETHATE SODIUM
Trade Name: TOBI
Product Name: Tobi
INN or Proposed INN: TOBRAMYCIN SULFATE
Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Austria
3EUCTR2011-000443-24-NL25/04/201306/07/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
4EUCTR2011-000443-24-DK14/12/201222/07/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
5EUCTR2011-000441-20-NL11/09/201206/07/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 13.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2011-000441-20-BG13/06/201203/05/2012Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 17.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Serbia;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
7EUCTR2011-000443-24-SE24/05/201207/06/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden
8EUCTR2011-000441-20-IE02/05/201226/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Code: TOBI
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
9EUCTR2011-000443-24-IT10/04/201219/03/2012Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin
Product Code: NA
INN or Proposed INN: AMIKACIN SULFATE
INSMED INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
250Greece;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Canada;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
10EUCTR2011-000441-20-DK29/03/201222/07/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2011-000443-24-BE30/01/201225/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
Product Code: N/A
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
12EUCTR2011-000441-20-BE30/01/201225/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
Product Code: N/A
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Name: TOBI
Product Code: N/A
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany
13EUCTR2011-000443-24-PL20/01/201206/10/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 16.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
14EUCTR2011-000443-24-DE11/10/201130/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 17.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
15EUCTR2011-000442-38-BG03/10/201105/07/2011Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaRandomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin Sulfate
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2011-000443-24-BG03/10/201128/07/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
17EUCTR2011-000441-20-IT01/10/201108/03/2012Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis
MedDRA version: 14.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
Product Code: NA
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: Tobi
INN or Proposed INN: TOBRAMYCIN
INSMED INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
300Hungary;Greece;Canada;Spain;Ireland;Denmark;Austria;Bulgaria;Netherlands;United Kingdom;Italy
18EUCTR2011-000442-38-ES21/09/201111/11/2011Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaRandomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaESTUDIO ALEATORIZADO, CONTROLADO CON PLACEBO, DOBLE CIEGO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE™ EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin Sulfate
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Poland;Spain;Ukraine;Australia;Bulgaria;New Zealand;Sweden
19EUCTR2011-000441-20-DE19/09/201130/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Name: TOBI
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
20EUCTR2011-000443-24-GR09/08/201123/06/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2011-000443-24-IE05/08/201126/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
22EUCTR2011-000441-20-GB03/08/201124/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
23EUCTR2011-000443-24-GB03/08/201124/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
24EUCTR2011-000443-24-FR28/07/201131/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 13.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
Product Code: NA
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
25EUCTR2011-000443-24-AT22/07/201127/06/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2011-000441-20-AT19/07/201121/06/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
27EUCTR2011-000441-20-GR15/07/201122/06/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
28EUCTR2011-000441-20-SK04/07/201125/11/2014Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 17.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
29EUCTR2011-000443-24-SK04/07/201120/02/2014Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 16.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Germany;New Zealand;Sweden;United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands
30EUCTR2011-000443-24-HU29/06/201111/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2011-000441-20-HU29/06/201120/04/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
32NCT01755455June 201119/12/2012Does a Daily Iron Tablet Improve Anemia in Cystic FibrosisIron Supplementation for the Hypoferremic Anemia of Cystic FibrosisCystic Fibrosis;Anemia, Iron-DeficiencyDrug: Ferrous sulfate 325mg;Drug: PlaceboDartmouth-Hitchcock Medical CenterNULLCompleted18 Years70 YearsAll22N/AUnited States
33EUCTR2006-006980-22-BE27/06/200719/07/2007MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSAMULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA Cystic fibrosis
MedDRA version: 9.1Level: LLTClassification code 10011762Term: Cystic fibrosis
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin sulfate
Transave, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Hungary;Belgium
34EUCTR2006-006980-22-PL22/08/2007MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSAMULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA Cystic fibrosis
MedDRA version: 9.1Level: LLTClassification code 10011762Term: Cystic fibrosis
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Transave, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Slovakia;Belgium;Poland
35EUCTR2011-000442-38-PL01/08/2011Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaRandomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin Sulfate
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden