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 (AZLI CAT)
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Purpose
Using a Continuous Alternating Therapy (CAT)regimen of 2 antibiotics of different classes with different mechanisms of action may provide the clinical benefits of reducing acute exacerbations, maintaining lung function and controlling respiratory symptoms for CF patients while minimizing the risk of emergence of antibiotic-resistant Pseudomonas aeruginosa (PA) strains.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis |
Drug: Aztreonam for Inhalation Solution (AZLI) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas Aeruginosa Infection in Subjects With Cystic Fibrosis |
- Rate of protocol-defined exacerbations from baseline through Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Average actual change from baseline in FEV1 % predicted at the end of each course of study drug [ Time Frame: Weeks 4, 12 and 20 ] [ Designated as safety issue: No ]
- Percent of subjects who use non-study IV or inhaled antibiotics for protocol-defined pulmonary exacerbations, baseline to Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | November 2012 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Aztreonam for Inhalation Solution (AZLI) |
Drug: Aztreonam for Inhalation Solution (AZLI)
75 mg (1 ml) of aztreonam, supplied as Aztreonam for Inhalation Solution (AZLI) administered three times a day for 28 days per course.
Other Name: Cayston
|
| Placebo Comparator: Sugar solution for inhalation |
Drug: Placebo
Sugar solution for inhalation administered three times a day for 28 days per course.
|
Detailed Description:
After screening, eligible participants will be enrolled into the study and begin a 28-day run in period of Tobramycin Inhalation Solution (TIS) twice daily. After the run-in, participants will return to the clinic and be randomized to either the AZLI arm or the placebo arm. The AZLI arm has 3 cycles of AZLI three times daily for 28 days alternating with TIS twice daily for 28 days. The placebo arm has 3 cycles of placebo three times daily for 28 days alternating with 3 cycles of TIS twice daily for 28 days. The participant will return to the clinic for evaluation after each cycle of antibiotics for evaluation. There will be 9 scheduled study visits per participant.
Eligibility| Ages Eligible for Study: | 6 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmed diagnosis of CF
- Presence of PA in 2 lower respiratory tract cultures in the 12 months prior to screening
- FEV1 ≥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
Contacts and Locations| Contact: Sheila Leitzinger | 206 256-4904 | sheila.leitzinger@gilead.com |
Show 76 Study Locations More Information
No publications provided
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01641822 History of Changes |
| Other Study ID Numbers: | GS-US-205-0170 |
| Study First Received: | July 13, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cystic Fibrosis Fibrosis Pseudomonas Infections Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |
Pathologic Processes Gram-Negative Bacterial Infections Bacterial Infections Aztreonam Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013