Advertisement

Topics

Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis and Chronic Burkholderia Species Infection

2014-08-27 03:16:15 | BioPortfolio

Summary

The purpose of this research study is to see if an experimental drug called Aztreonam for Inhalation Solution is safe and effective to treat Burkholderia lung infections in patients with Cystic fibrosis.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Cystic Fibrosis

Intervention

Aztreonam for Inhalation solution

Location

Pulmonary Associates of Mobile, P.C.
Mobile
Alabama
United States
36608

Status

Recruiting

Source

Gilead Sciences

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:15-0400

Clinical Trials [1609 Associated Clinical Trials listed on BioPortfolio]

Aztreonam for Inhalation Solution (AZLI) vs Tobramycin Inhalation Solution (TOBI®) in Patients With CF & P. Aeruginosa

The purpose of this study is to assess the comparative safety and effectiveness of Aztreonam for Inhalation Solution versus Tobramycin Nebuliser Solution in adult and pediatric patients wi...

Safety and Efficacy Study of Aztreonam Lysinate for Inhalation (AI) in Cystic Fibrosis Patients With P. Aeruginosa

The purpose of this study is to see if aztreonam lysinate for inhalation (AI) is safe and effective for cystic fibrosis (CF) patients with lung infections due to a bacteria called Pseudomo...

Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection

The primary objective of this program is to provide expanded access to aztreonam lysine for inhalation (AZLI) 75 mg prior to its commercial availability to patients with cystic fibrosis (C...

International Safety and Efficacy Study of Aztreonam Lysinate for Inhalation (AI) in Cystic Fibrosis Patients

The purpose of this study is to see if a 28-day course of AI is safe and effective for cystic fibrosis (CF) patients with lung disease due to Pseudomonas aeruginosa (PA) infection.

Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis

This program is to provide expanded access to aztreonam lysine for inhalation (AZLI) prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P. aeruginosa ai...

PubMed Articles [5603 Associated PubMed Articles listed on BioPortfolio]

Lack of efficacy of Lactobacillus GG in reducing pulmonary exacerbations and hospital admissions in children with cystic fibrosis: A randomised placebo controlled trial.

Intestinal dysbiosis has been described in Cystic Fibrosis (CF) and probiotics have been proposed to restore microbial composition. Aim of the study was to investigate the effects of Lactobacillus rha...

End-of-life practice patterns at U.S. adult cystic fibrosis care centers: A national retrospective chart review.

There are many challenges to providing end-of-life care (EOLC) to people with cystic fibrosis (CF).

Functional lung MRI for regional monitoring of patients with cystic fibrosis.

To test quantitative functional lung MRI techniques in young adults with cystic fibrosis (CF) compared to healthy volunteers and to monitor immediate treatment effects of a single inhalation of hypert...

Development and validation of an LC tandem MS assay for the quantification of β-lactam antibiotics in the sputum of cystic fibrosis patients.

Antibiotic therapy is of vital importance for the control of infectious exacerbations in cystic fibrosis (CF) patients. However, very little is known regarding the fraction of systemically administere...

Audiometric assessment of pediatric patients with cystic fibrosis.

The purpose of this study was to evaluate hearing impairment in pediatric patients with cystic fibrosis (CF).

Medical and Biotech [MESH] Definitions

An autosomal recessive genetic disease of the EXOCRINE GLANDS. It is caused by mutations in the gene encoding the CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR expressed in several organs including the LUNG, the PANCREAS, the BILIARY SYSTEM, and the SWEAT GLANDS. Cystic fibrosis is characterized by epithelial secretory dysfunction associated with ductal obstruction resulting in AIRWAY OBSTRUCTION; chronic RESPIRATORY INFECTIONS; PANCREATIC INSUFFICIENCY; maldigestion; salt depletion; and HEAT PROSTRATION.

A chloride channel that regulates secretion in many exocrine tissues. Abnormalities in the CFTR gene have been shown to cause cystic fibrosis. (Hum Genet 1994;93(4):364-8)

A strain of mice widely studied as a model for cystic fibrosis. These mice are generated from embryonic stem cells in which the CFTR (cystic fibrosis transmembrane conductance regulator) gene is inactivated by gene targeting. As a result, all mice have one copy of this altered gene in all their tissues. Mice homozygous for the disrupted gene exhibit many features common to young cystic fibrosis patients, including failure to thrive, meconium ileus, and alteration of mucous and serous glands.

Hypertonic sodium chloride solution. A solution having an osmotic pressure greater than that of physiologic salt solution (0.9 g NaCl in 100 ml purified water).

A species of STENOTROPHOMONAS, formerly called Xanthomonas maltophilia, which reduces nitrate. It is a cause of hospital-acquired ocular and lung infections, especially in those patients with cystic fibrosis and those who are immunosuppressed.

More From BioPortfolio on "Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis and Chronic Burkholderia Species Infection"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Pulmonary
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...


Searches Linking to this Trial