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Be Part of Research - Trial Details - Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa

Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa

Completed

Open to: ALL

Age: 6.0 - N/A

Medical Conditions

Cystic Fibrosis
Respiratory Aspiration
Fibrosis


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Aug 2008 May 2010

Publications

"Assael BM, Pressler T, Bilton D, Fayon M, Fischer R, Chiron R, LaRosa M, Knoop C, McElvaney N, Lewis SA, Bresnik M, Montgomery AB, Oermann CM; AZLI Active Comparator Study Group. Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial. J Cyst Fibros. 2013 Mar;12(2):130-40. doi: 10.1016/j.jcf.2012.07.006. Epub 2012 Sep 15."; "22985692"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Aztreonam for inhalation solution (75 mg) was administered 3 times a day (TID) for 28 days for each treatment cycle via the PARI eFlow electronic nebulizer.

Intervention Arm Group : AZLI 75 mg 3 times a day (TID);

Intervention Type : DRUG
Intervention Description : Tobramycin inhalation solution (300 mg) was administered 2 times a day (BID) for 28 days for each treatment cycle via the PARI LC Plus nebulizer with compressor or via another nebulizer compatible with country-specified labeling.

Intervention Arm Group : TIS 300 mg 2 times a day (BID);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Belfast
    BT9 7AB
  • Leeds
    LS9 7TF
  • Southampton
    SO16 6YD
  • London
    SW3 6NP
  • Cambridge
    CB23 3RE
  • Sheffield
    West Yorkshire
    S10 2TH
  • Cardiff
    CF64-2XX
  • Liverpool
    L14 3PE


The study is sponsored by Gilead Sciences and is in collaboration with Chiltern International Inc.; ClinPhone, Inc.; Covance.




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Read full details for Trial ID: NCT00757237
Last updated 07 June 2011

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