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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

January 23, 2010
January 25, 2010
June 2003
August 2004   (final data collection date for primary outcome measure)
Change in FEV1 from Baseline to Day 14 [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01055847 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cystic Fibrosis
  • CF
  • Lung Infection
  • Pseudomonas Aeruginosa
  • Drug: Aztreonam for Inhalation (AI)
    Aztreonam for Inhalation
    Other Name: AI
  • Drug: Placebo
    Saline Placebo
  • Experimental: AI 75 mg
    Aztreonam for Inhalation 75 mg twice daily
    Intervention: Drug: Aztreonam for Inhalation (AI)
  • Experimental: AI 225 mg
    Aztreonam for Inhalation 225 mg twice daily
    Intervention: Drug: Aztreonam for Inhalation (AI)
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
September 2004
August 2004   (final data collection date for primary outcome measure)

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01055847
CP-AI-003
Yes
A. Bruce Montgomery, Sr. VP Gilead Sciences
Gilead Sciences
Conducted under Salus Pharma, Inc.
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
Gilead Sciences
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP