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

This study has been completed.
Sponsor:
Collaborator:
Conducted under Salus Pharma, Inc.
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01055847
First received: January 23, 2010
Last updated: January 25, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
CF
Lung Infection
Pseudomonas Aeruginosa
Drug: Aztreonam for Inhalation (AI)
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Change in FEV1 from Baseline to Day 14 [ Time Frame: 14 Days ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: June 2003
Study Completion Date: September 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AI 75 mg
Aztreonam for Inhalation 75 mg twice daily
Drug: Aztreonam for Inhalation (AI)
Aztreonam for Inhalation
Other Name: AI
Experimental: AI 225 mg
Aztreonam for Inhalation 225 mg twice daily
Drug: Aztreonam for Inhalation (AI)
Aztreonam for Inhalation
Other Name: AI
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Saline Placebo

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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055847

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
United States, Colorado
Denver, Colorado, United States, 80218
United States, Florida
Gainsville, Florida, United States, 32610
Orlando, Florida, United States, 32806
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Michigan
Ann Arbor, Michigan, United States, 48109-0212
United States, Nebraska
Omaha, Nebraska, United States, 68198-5190
United States, North Carolina
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Cleveland, Ohio, United States, 44106
Columbus, Ohio, United States, 43205-2696
Dayton, Ohio, United States, 45404
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19129
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Houston, Texas, United States, 77030
United States, Utah
Salt Lake City, Utah, United States, 84132
United States, Washington
Seattle, Washington, United States, 98105
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Gilead Sciences
Conducted under 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
  More Information

No publications provided

Responsible Party: A. Bruce Montgomery, Sr. VP Gilead Sciences
ClinicalTrials.gov Identifier: NCT01055847     History of Changes
Other Study ID Numbers: CP-AI-003
Study First Received: January 23, 2010
Last Updated: January 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
cystic fibrosis
CF
aztreonam
lung infection
Pseudomonas aeruginosa

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 April 17, 2014