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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis; Pseudomonas Aeruginosa; Lung Infection; CF
• Intervention / Treatment: Drug: Placebo; Drug: Aztreonam for Inhalation (AI)

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
    • Orange, California, United States, 92868
    • San Diego, California, United States, 92103-8376
    • Stanford, California, United States, 94305
  • Colorado
    • Denver, Colorado, United States, 80218
  • Florida
    • Gainsville, Florida, United States, 32610
    • Orlando, Florida, United States, 32806
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0212
  • Nebraska
    • Omaha, Nebraska, United States, 68198-5190
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
  • Ohio
    • Cleveland, Ohio, United States, 44106
    • Columbus, Ohio, United States, 43205-2696
    • Dayton, Ohio, United States, 45404
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19129
  • South Carolina
    • Charleston, South Carolina, United States, 29425
  • Texas
    • Houston, Texas, United States, 77030
  • Utah
    • Salt Lake City, Utah, United States, 84132
  • Washington
    • Seattle, Washington, United States, 98105
  • Wisconsin
    • Madison, Wisconsin, United States, 53792

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Saline Placebo
Experimental: AI 75 mg; Aztreonam for Inhalation 75 mg twice daily	Drug: Aztreonam for Inhalation (AI); Aztreonam for Inhalation; Other Names: AI
Experimental: AI 225 mg; Aztreonam for Inhalation 225 mg twice daily	Drug: Aztreonam for Inhalation (AI); Aztreonam for Inhalation; Other Names: AI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in FEV1 from Baseline to Day 14	14 Days

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Collaborators: Salus Pharma, Inc.
• Investigators: 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 record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion (Actual): August 1, 2004
• Study Completion (Actual): September 1, 2004

Study Registration Dates

• First Submitted: January 23, 2010
• First Submitted That Met QC Criteria: January 25, 2010
• First Posted (Estimate): January 26, 2010

Study Record Updates

• Last Update Posted (Estimate): January 26, 2010
• Last Update Submitted That Met QC Criteria: January 25, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: cystic fibrosis; Pseudomonas aeruginosa; CF; aztreonam; lung infection
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pancreatic Diseases; Fibrosis; Infections; Communicable Diseases; Cystic Fibrosis; Pseudomonas Infections; Anti-Infective Agents; Anti-Bacterial Agents; Aztreonam
• Other Study ID Numbers: CP-AI-003