Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa Infection

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis, CF, Lung Infection, Pseudomonas Aeruginosa

In brief

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.

Key facts

Study ID

NCT01055847

Run by

Gilead Sciences

People needed

105

Starts

2003-06-01

Expected to finish

2004-09-01

Last updated by the study team

2010-01-26

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent prior to the performance of any study related procedures.
• 13 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).
• Findings at Visit 1 (Screening) that, in the investigator's opinion, would compromise the safety of the patient or the quality of the study data.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Orange, California, United States
• Study site — San Diego, California, United States
• Study site — Stanford, California, United States
• Study site — Denver, Colorado, United States
• Study site — Gainsville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Omaha, Nebraska, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Dayton, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Houston, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Seattle, Washington, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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