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

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis; CF; Lung Infection; Pseudomonas Aeruginosa

Intervention: Aztreonam for Inhalation (AI) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Ronald L Gibson, Jr., MD, Principal Investigator, Affiliation: Children's Hospital and Regional Medica Center, Seattle, WA
George Retsch-Bogart, MD, Principal Investigator, Affiliation: University of North Carolina Hospitals, Chapel Hill, NC

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.

Clinical Details

Official title: A Blinded, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam for Inhalation (AI) in Cystic Fibrosis Patient With Lung Disease Due to P. Aeruginosa Infection

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in FEV1 from Baseline to Day 14

Detailed description: This is multicenter placebo-controlled study evaluating the safety and efficacy of a 14-day treatment of AI at two dosage levels as compared to placebo, given twice daily, in CF patients with P. aeruginosa lung infection, delivered by the eFlow investigational nebulizer.

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Locations and Contacts

Los Angeles, California 90027, United States

Orange, California 92868, United States

San Diego, California 92103-8376, United States

Stanford, California 94305, United States

Denver, Colorado 80218, United States

Gainsville, Florida 32610, United States

Orlando, Florida 32806, United States

Boston, Massachusetts 02114, United States

Ann Arbor, Michigan 48109-0212, United States

Omaha, Nebraska 68198-5190, United States

Chapel Hill, North Carolina 27514, United States

Cleveland, Ohio 44106, United States

Columbus, Ohio 43205-2696, United States

Dayton, Ohio 45404, United States

Philadelphia, Pennsylvania 19129, United States

Charleston, South Carolina 29425, United States

Houston, Texas 77030, United States

Salt Lake City, Utah 84132, United States

Seattle, Washington 98105, United States

Madison, Wisconsin 53792, United States

Additional Information

Starting date: June 2003
Last updated: January 25, 2010

Page last updated: August 20, 2015

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