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Study Name on (link is external)
Aztreonam Lysine for Pseudomonas Infection Eradication Study (ALPINE)
Study DrugAztreonam Lysine for Inhalation (AZLI)
Type of Study DrugAnti-infective
Study TitleOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution /Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients With Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas Aeruginosa (PA)
Study Phase2
Study SponsorGilead

Link on (link is external) (link is external)

Participating ECFS-CTN sitesBelgium: Leuven
France: Bordeaux, Paris (Necker, Debré), Roscoff
Germany: Berlin, Frankfurt
Italy: Florence, Verona
The Netherlands: Rotterdam, Utrecht
Spain: Barcelona
Age3 months to less than 18 years

Study Results

The trial (NCT01375049) "an open-label phase 2 trial to evaluate the safety and efficacy of aztreonam 75 mg powder and solvent for nebuliser solution /aztreonam for inhalation solution (AZLI) in pediatric patients with cystic fibrosis (CF) and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa (Pa)" was conducted in 47 sites across Europe and the US. One hundred and 5 CF patients (3 months to < 18 years, mean age±SD: 6.3±4.7 years) with a newly positive Pa infection within 30 days of study entry were enrolled to evaluate the safety and efficacy of a 28-day course of AZLI (75 mg 3 times daily, PARI Investigational eFlow® Nebulizer system). In 102 cultures obtained at baseline, Pa was present in 45/102 (44%). The results showed that in all evaluable subjects, Pa cultures were negative at D28 in 90% and at Day 56 in 70% of cases. For the sub-group of evaluable subjects with Pa-positive baseline cultures (n=45), Pa cultures were negative at D28 in 85% and at Day 56 in 67% of cases. Adverse events were consistent with data from previous AZLI trials.

11 ECFS-CTN sites in country Belgium, France, Italy, The Netherlands and Spain participated in this study and enrolled 23 of the 105 patients.

The summary of data provided here are from data presented at the North American Cystic Fibrosis Conference (2013)