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ALPINE 2: AZLI for children with CF and PA lung 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

Aztreonam antiobiotic

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
  • Age 3 months to less than 18 years old
  • FEV1 ≥ 80% predicted (for subjects ≥ 6 years of age
  • Documented new onset of positive respiratory tract culture for Pseudomonas Aeruginosa within 30 days of screening.
Top exclusion criteria
  • Use of oral antipseudomonal antibiotics within 30 days of study entry (screening visit).
  • Use of IV or inhaled antipseudomonal antibiotics within 2 years of screening visit.

CF centres running this trial

Recruiting

Birmingham Children's Hospital

Address

Steelhouse Lane Birmingham West Midlands B4 6NH

Recruitment starts

February 2018

Recruitment ends

December 2019

Contact

Nagakumar, Prasad

Get in touch

Recruiting

Leicester Royal Infirmary

Address

Infirmary Square Leicester Leicestershire LE1 5WW

Recruitment starts

January 2018

Recruitment ends

June 2021

Contact

Gaillard, Erol

Get in touch

Recruiting

Royal Cornwall Hospital (Treliske)

Address

Royal Cornwall Hospital Treliske Truro Cornwall TR1 3LJ

Recruitment starts

February 2018

Recruitment ends

December 2019

Contact

Nath, Stuart

Get in touch

Recruiting

Southampton General Hospital

Address

Tremona Road Southampton Hampshire SO16 6YD

Recruitment starts

January 2018

Recruitment ends

December 2019

Contact

Legg, Julian

Get in touch
Show all participating centres