CAYSTON aztreonam 75 mg powder and solvent for nebuliser solution ( DrugBank: Aztreonam )


1 disease
IDDisease name (Link within this page)Number of trials
299Cystic fibrosis2

299. Cystic fibrosis


Clinical trials : 1,695 Drugs : 1,527 - (DrugBank : 268) / Drug target genes : 111 - Drug target pathways : 174
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agemin
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PhaseCountries
1EUCTR2011-001362-18-IT
(EUCTR)
08/02/201222/02/2012Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways. - PALS (Pediatric Aztreonam Lysine Safety) Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways. - PALS (Pediatric Aztreonam Lysine Safety) Cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa.
MedDRA version: 14.1;Level: SOC;Classification code 10021881;Term: Infections and infestations;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1;Level: PT;Classification code 10056971;Term: Infective exacerbation of chronic obstructive airways disease;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: CAYSTON aztreonam 75 mg powder and solvent for nebuliser solution
INN or Proposed INN: AZTREONAM
Other descriptive name: NA
GILEAD SCIENCES INC.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;United States;Spain;Germany;Italy
2EUCTR2011-001255-36-IT
(EUCTR)
27/01/201228/09/2012Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients with Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas aeruginosa (PA) Aztreonam Lysine for Pseudomonas Infection Eradication (ALPINE)study - ALPINE Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 15.0;Level: PT;Classification code 10056971;Term: Infective exacerbation of chronic obstructive airways disease;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 15.0;Level: SOC;Classification code 10021881;Term: Infections and infestations;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston Aztreonam 75 mg powder and solvent for nebuliser solution
INN or Proposed INN: AZTREONAM
GILEAD SCIENCES INC.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;Spain;Ireland;Austria;Netherlands;Germany;Italy