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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01055847
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : January 26, 2010
Sponsor:
Collaborator:
Salus Pharma, Inc.
Information provided by:
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE January 23, 2010
First Posted Date  ICMJE January 26, 2010
Last Update Posted Date January 26, 2010
Study Start Date  ICMJE June 2003
Actual Primary Completion Date August 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2010)
Change in FEV1 from Baseline to Day 14 [ Time Frame: 14 Days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa Infection
Official Title  ICMJE A Blinded, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam for Inhalation (AI) in Cystic Fibrosis Patient With Lung Disease Due to P. Aeruginosa Infection
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cystic Fibrosis
  • CF
  • Lung Infection
  • Pseudomonas Aeruginosa
Intervention  ICMJE
  • Drug: Aztreonam for Inhalation (AI)
    Aztreonam for Inhalation
    Other Name: AI
  • Drug: Placebo
    Saline Placebo
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2010)
105
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2004
Actual Primary Completion Date August 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01055847
Other Study ID Numbers  ICMJE CP-AI-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party A. Bruce Montgomery, Sr. VP Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Salus Pharma, Inc.
Investigators  ICMJE
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
PRS Account Gilead Sciences
Verification Date January 2010

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