Aztreonam Lysine for Inhalation ( DrugBank: Lysine, Aztreonam )


1 disease
IDDisease name (Link within this page)Number of trials
299Cystic fibrosis10

299. Cystic fibrosis


Clinical trials : 1,696 Drugs : 1,644 - (DrugBank : 272) / Drug target genes : 96 - Drug target pathways : 170
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PhaseCountries
1NCT01460836
(ClinicalTrials.gov)
April 201025/10/2011Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic FibrosisIndirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic FibrosisCystic FibrosisDrug: Tobramycin solution for inhalation;Drug: Aztreonam lysine for inhalationNovartis PharmaceuticalsNULLCompleted6 YearsN/ABothN/ANULL
2NCT00989807
(ClinicalTrials.gov)
September 20092/10/2009Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic FibrosisExpanded Access for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease ProgressionCystic Fibrosis;Pseudomonas AeruginosaDrug: Aztreonam lysineGilead SciencesNULLApproved for marketing6 YearsN/ABothN/ACanada
3EUCTR2007-004277-26-ES
(EUCTR)
25/08/200824/01/2008An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quísticaAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. Pacientes adultos y pediátricos con fibrosis quística (FQ) con infección pulmonar por Pseudomonas aeruginosa (PA).
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;France;Belgium;Spain;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom
4EUCTR2007-004277-26-IE
(EUCTR)
19/06/200827/02/2008An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria
5NCT00712166
(ClinicalTrials.gov)
May 20087/7/2008Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. AeruginosaA Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)Cystic Fibrosis;Lung Infection;Pseudomonas AeruginosaDrug: AZLI 75 mg three times daily (TID);Drug: Placebo three times daily (TID)Gilead SciencesNULLCompleted6 YearsN/AAll160Phase 3United States;Australia;Canada
6EUCTR2007-004277-26-FR
(EUCTR)
30/04/200821/01/2008An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom
7NCT00499720
(ClinicalTrials.gov)
October 20039/7/2007Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway InfectionExpanded Access Program for Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease ProgressionCystic Fibrosis;Pseudomonas Aeruginosa Airway InfectionDrug: Aztreonam Lysine for InhalationGilead SciencesNULLApproved for marketing6 YearsN/ABothN/AUnited States;Puerto Rico
8EUCTR2015-000395-97-Outside-EU/EEA
(EUCTR)
02/02/2015A Clinical Trial to Evaluate the Effects of the drug Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and infection with the bacteria Pseudomonas aeruginosa (AIR-CF4)A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and P. aeruginosa (AIR-CF4) Cystic Fibrosis with Mild Lung Disease and P. aeruginosa (AIR-CF4);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Cayston
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.Gilead Sciences Pty Ltd;Gilead Sciences Canada, Inc.NAFemale: yes
Male: yes
157United States;Australia;Canada
9EUCTR2015-000396-26-Outside-EU/EEA
(EUCTR)
02/02/2015Program to Give the Drug Aztreonam Lysine for Inhalation to Patients with Cystic Fibrosis and infection by the Bacteria Pseudomonas aeruginosa Who Have Limited Treatment Options and are at Risk for Disease ProgressionExpanded Access Program for Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk for Disease Progression Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Cayston
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNAFemale: yes
Male: yes
603United States
10EUCTR2015-000397-36-Outside-EU/EEA
(EUCTR)
03/02/2015Program to Give the Drug Aztreonamn Lysine for Inhalation to Canadian Patients with Cystic Fibrosis and infection by the Bacteria Pseudomonas aeruginosa Who Have Limited Treatment Options and are at Risk for Disease ProgressionExpanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk for Disease Progression Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 17.1;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: Cayston
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNAFemale: yes
Male: yes
45Canada