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Safety and Efficacy of 2 Treatment Regimens of Aztreonam for Inhalation Solution in Children With Cystic Fibrosis and New Onset Pseudomonas Aeruginosa Infection

Details

Therapeutic category
the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Anti-Infective

Trial status

Open to recruitment

Participating Centres
Phase
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

Phase III

Full title

Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization

The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in participants with new onset Pseudomonas aeruginosa respiratory tract infection.

Trial Reference Number

88959

Trial type

Medication

Length of participation
the length of time a participant will take part in a trial, from the first to the last appointment

28 days

Intervention
the name of the treatment or therapy being researched

AZLI Placebo

Recruitment target
the number of participants who need to be recruited for the trial in the UK

140

Last edited date

15 December 2016

CF sponsor

Gilead Sciences

CF sponsor type

Commercial

Who can take part?

Top inclusion criteria
  • Forced expiratory volume in one second (FEV1) ≥ 80% predicted (for subjects ≥ 6 years of age who can reliably perform spirometry assessments).
  • Clinically stable with no evidence of acute significant respiratory symptoms that would require administration of IV antipseudomonal antibiotics, oxygen supplementation, or hospitalization.
  • Documented new onset of positive respiratory tract culture for PA within 30 days of screening defined as either first lifetime documented PA-positive culture, or PA recovered after at least a 2-year history of PA-negative respiratory cultures (at least 2 cultures per year)
Top exclusion criteria
  • Use of oral antipseudomonal antibiotics for a respiratory event within 30 days of study entry (screening visit).
  • Changes in bronchodilator, corticosteroid, dornase alfa, or hypertonic saline medications within 7 days prior to screening.
  • Use of IV or inhaled antipseudomonal antibiotics within 2 years of screening.

CF centres running this trial

Recruiting

Aberdeen Royal Infirmary

Address

Foresterhill, Aberdeen AB25 2ZN

Recruitment ends

June 2019

Contact

,

Get in touch

Recruiting

Barts Health NHS Trust

Address

Trust headquarters 5th Floor Aneurin Bevan House 81 Commercial Road London E1 1RD

Recruitment starts

February 2018

Recruitment ends

June 2019

Contact

Pao, Caroline

Get in touch

Recruiting

King's College Hospital NHS Foundation Trust

Address

Denmark Hill London Greater London SE5 9RS

Recruitment starts

March 2018

Recruitment ends

May 2019

Contact

Ruiz, Gary

Get in touch

Recruiting

Leicester Royal Infirmary

Address

Infirmary SquareLeicesterInfirmary SquareLeicestershire LE1 5WW

Recruitment starts

January 2018

Recruitment ends

June 2021

Contact

Gaillard, Erol

Get in touch
Show all participating centres