Aztreonam for non-CF Bronchiectasis and Endobronchial Infection

• Research type

  Research Study

• Full title

  A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects with non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)

• IRAS ID

  77531

• Sponsor organisation

  Gilead Sicence, Inc

• Eudract number

  2010-023959-28

• Research summary

  This is a Phase 3 study designed to test how safe and effective the study drug, Aztreonam for inhalation solution/aztreonam 75 mg powder and solvent for nebuliser solution (AZLI), is for treating patients with non-Cystic Fibrosis bronchiectasis and gram-negative endobronchial infection.Bronchiectasis is a disease of the lungs with permanent widening of the airways. People with bronchiectasis often have long-term lung infections that flare up occasionally and worsen over time. Lung infections are caused by bacteria (germs). Treatment with antibiotics is used to stop or slow down the growth of bacteria. The antibiotics may be given by mouth, into a vein (IV), or inhaled as a mist. The study drug Aztreonam (AZLI) is an antibiotic that's inhaled as a mist.AZLI is currently not licensed in the UK or Europe for treating patients with bronchiectasis and with bacterial infections and is available for clinical research purposes only. It is planned that approximately 172 adult patients who have bronchiectasis and bacterial infections will participate in this study at about 55 study centers in the USA and Europe. Patients are expected to remain in the study for 30 weeks

• REC name

  Scotland A REC

• REC reference

  11/AL/0286

• Date of REC Opinion

  4 Jul 2011

• REC opinion

  Further Information Favourable Opinion