Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa Infection
A Blinded, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam for Inhalation (AI) in Cystic Fibrosis Patient With Lung Disease Due to P. Aeruginosa Infection
1 other identifier
interventional
105
1 country
20
Brief Summary
This is multicenter placebo-controlled study evaluating the safety and efficacy of AI at two dosage levels compared to placebo in CF patients with P. aeruginosa lung infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2003
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 23, 2010
CompletedFirst Posted
Study publicly available on registry
January 26, 2010
CompletedJanuary 26, 2010
January 1, 2010
1.2 years
January 23, 2010
January 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in FEV1 from Baseline to Day 14
14 Days
Study Arms (3)
AI 75 mg
EXPERIMENTALAztreonam for Inhalation 75 mg twice daily
AI 225 mg
EXPERIMENTALAztreonam for Inhalation 225 mg twice daily
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent prior to the performance of any study related procedures.
- years of age and above.
- Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT) or homozygosity for ΔF508 genetic mutation or heterozygosity for two well characterized mutations.
- Ability to perform pulmonary function tests.
- FEV1 ≥ 40% predicted at Visit 1 (Screening).
- SaO2 ≥ 90% at Visit 1 (Screening).
- P. aeruginosa present in sputum at Visit 1 (Screening).
- Ability to expectorate sputum on a daily basis.
You may not qualify if:
- Administration of any antibiotic with antipseudomonal activity by any route within 56 days prior to Visit 1 (Screening).
- Administration of any investigational drug or device within 28 days of Visit 1 (Screening) and within 6 half-lives of the investigational drug.
- Oral corticosteroids in doses exceeding 10 mg per day or 20 mg every other day.
- History of sputum culture or throat swab culture yielding B. cepacia in the previous two years.
- Current daily continuous oxygen supplementation or requirement for more than 2 L/min at night.
- Known local or systemic hypersensitivity to monobactam antibiotics.
- Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid medications within 7 days prior to Visit 1 (Screening).
- Changes in physiotherapy technique or schedule within 7 days prior to Visit 1 (Screening).
- History of lung transplantation.
- A chest radiograph at Visit 1 (Screening) or within the previous 90 days of Screening, with abnormalities indicating a significant acute finding (eg, lobar infiltrate and atelectasis, pneumothorax, or pleural effusion).
- Abnormal renal or hepatic function or serum chemistry at Visit 1 (Screening):
- AST, ALT \> 2.5 times upper limit of normal range.
- Creatinine \> 1.5 times upper limit of normal range.
- Positive pregnancy test. All women of childbearing potential will be tested.
- Female of childbearing potential who is lactating or is not practicing acceptable method of birth control (eg, hormonal or barrier methods, or IUD).
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
- Salus Pharma, Inc.collaborator
Study Sites (20)
Unknown Facility
Los Angeles, California, 90027, United States
Unknown Facility
Orange, California, 92868, United States
Unknown Facility
San Diego, California, 92103-8376, United States
Unknown Facility
Stanford, California, 94305, United States
Unknown Facility
Denver, Colorado, 80218, United States
Unknown Facility
Gainsville, Florida, 32610, United States
Unknown Facility
Orlando, Florida, 32806, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Ann Arbor, Michigan, 48109-0212, United States
Unknown Facility
Omaha, Nebraska, 68198-5190, United States
Unknown Facility
Chapel Hill, North Carolina, 27514, United States
Unknown Facility
Cleveland, Ohio, 44106, United States
Unknown Facility
Columbus, Ohio, 43205-2696, United States
Unknown Facility
Dayton, Ohio, 45404, United States
Unknown Facility
Philadelphia, Pennsylvania, 19129, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Seattle, Washington, 98105, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald L Gibson, Jr., MD
Children's Hospital and Regional Medica Center, Seattle, WA
- PRINCIPAL INVESTIGATOR
George Retsch-Bogart, MD
University of North Carolina Hospitals, Chapel Hill, NC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 23, 2010
First Posted
January 26, 2010
Study Start
June 1, 2003
Primary Completion
August 1, 2004
Study Completion
September 1, 2004
Last Updated
January 26, 2010
Record last verified: 2010-01