Phase 3
Completed N=107
Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF
Source: ClinicalTrials.gov NCT01641822 ↗Enrolled (actual)
107
Serious AEs
25.1%
Results posted
May 2016
Primary outcomePrimary: Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24 — 1.309; 1.762 PDEs per participant year — p=0.25
◆ Published Evidence
Established
58citations · ~6 / year
Continuous alternating inhaled antibiotics for chronic pseudomonal infection in cystic fibrosis.
Summary
The primary objective of this study is to evaluate the safety and efficacy of a CAT regimen with aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) in adult and pediatric subjects with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection. Participants will be enrolled in a 28 day TIS run-in phase, and will be eligible for randomization in the comparative phase if they have not received non-study oral antibiotics for a respiratory event, or IV or inhaled antibiotics for any indication between Visits 2 and 3, have not developed a condition requiring hospitalization or other change in clinical status which, in the opinion of the investigator would preclude their ability to continue in the study, and have demonstrated at least 50% TIS compliance. Participants enrolled in the comparative phase will be randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI or placebo for 28 days followed by TIS for 28 days.
Linked Publications
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Continuous alternating inhaled antibiotics for chronic pseudomonal infection in cystic fibrosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24 |
1.309; 1.762 | 0.25 |
| SECONDARY Average Actual Change From Baseline in FEV1 % Predicted Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20) |
1.37; 0.04 | 0.16 |
| SECONDARY Percentage of Participants Who Used Non-study IV or Inhaled Antibiotics for PDEs |
48.8; 55.3 | 0.67 |
| SECONDARY Time to First Protocol-defined Pulmonary Exacerbation |
175; 140.0 | 0.71 |
| SECONDARY Rate of Hospitalizations for a Respiratory Event |
1.043; 1.624 | 0.14 |
| SECONDARY Average Change From Baseline in the CFQ-R Respiratory Symptom Scale (RSS) Score Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20) |
1.00; -2.06 | 0.21 |
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of CF
- Presence of PA in 2 lower respiratory tract cultures in the 12 months prior to screening
- Forced expiratory volume (FEV)1 ≥ 25 and ≤ 75% predicted
- History of 1 hospitalization or 1 course of IV antibiotics for an acute respiratory exacerbation in the 12 months prior to screening
Exclusion Criteria
- Concurrent use of oral, IV or inhaled antibiotics at enrollment
- Concurrent hospitalization at enrollment
- History of local or systemic hypersensitivity to monobactams or aminoglycoside antibiotics or history of aminoglycoside antibiotic associated toxicity
Data sourced from ClinicalTrials.gov (NCT01641822) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.