Phase 3
N=273
Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00757237 ↗Enrolled (actual)
273
Serious AEs
32.1%
Results posted
Jul 2011
Primary outcome: Primary: Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28 — 8.35; 0.55 percent change in FEV1 percent predicted — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aztreonam for Inhalation Solution (AZLI) (Drug); Tobramycin Inhalation Solution (TIS) (Drug)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28 |
8.35; 0.55 | 0.0001 sig |
| PRIMARY Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses |
2.05; -0.66 | 0.0023 sig |
| SECONDARY Relative Change From Baseline in FEV1 Percent Predicted at Day 28 in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization |
10.04; 0.54 | <0.0001 sig |
| SECONDARY Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization |
3.26; -0.21 | 0.0002 sig |
| SECONDARY Time to Need for Intravenous (IV) Antipseudomonal Antibiotics for Respiratory Events |
NA; 151 | 0.0025 sig |
| SECONDARY Time to First Respiratory Hospitalization |
NA; NA | 0.1114 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Males or females aged 6 years and older
- Subjects with CF as diagnosed by one of the following: documented sweat chloride >= 60 mEq/L by quantitative pilocarpine iontophoresis test, or documented sweat sodium >= 60 mmol/L, or 2 well characterized genetic mutations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene, or abnormal nasal potential difference with accompanying symptoms characteristic of CF
- Documented PA in an expectorated sputum or throat swab culture within 3 months prior to Visit 1 or at Visit 1
- Subjects must be able to provide written informed consent/assent prior to any study related procedures; parent/guardian must be able to give written informed consent as necessary prior to any study related procedure
- Subjects must have received previous treatment with aerosolized antibiotics without demonstration of drug intolerance
- FEV1 5 times upper limit of normal range (ULN) or creatinine > 2 times ULN
- Positive pregnancy test at Visit 1; all women of childbearing potential will be tested
- Female of childbearing potential who is lactating or is not (in the opinion of the investigator) practicing an acceptable method of birth control; female subjects who utilize hormonal contraceptives as one of their birth control methods must have used the same method for at least 3 months before study dosing
- Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patient treatment, assessment, or compliance with the protocol
Data sourced from ClinicalTrials.gov (NCT00757237). 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.