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

Primary Purpose

Cystic Fibrosis, CF, Lung Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aztreonam for Inhalation (AI)
Placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis, CF, aztreonam, lung infection, Pseudomonas aeruginosa

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

AI 75 mg

AI 225 mg

Placebo

Arm Description

Aztreonam for Inhalation 75 mg twice daily

Aztreonam for Inhalation 225 mg twice daily

Placebo

Outcomes

Primary Outcome Measures

Change in FEV1 from Baseline to Day 14

Secondary Outcome Measures

Full Information

First Posted
January 23, 2010
Last Updated
January 25, 2010
Sponsor
Gilead Sciences
Collaborators
Salus Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01055847
Brief Title
Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa Infection
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 Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Gilead Sciences
Collaborators
Salus Pharma, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, CF, Lung Infection, Pseudomonas Aeruginosa
Keywords
cystic fibrosis, CF, aztreonam, lung infection, Pseudomonas aeruginosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AI 75 mg
Arm Type
Experimental
Arm Description
Aztreonam for Inhalation 75 mg twice daily
Arm Title
AI 225 mg
Arm Type
Experimental
Arm Description
Aztreonam for Inhalation 225 mg twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Aztreonam for Inhalation (AI)
Other Intervention Name(s)
AI
Intervention Description
Aztreonam for Inhalation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline Placebo
Primary Outcome Measure Information:
Title
Change in FEV1 from Baseline to Day 14
Time Frame
14 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald L Gibson, Jr., MD
Organizational Affiliation
Children's Hospital and Regional Medica Center, Seattle, WA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George Retsch-Bogart, MD
Organizational Affiliation
University of North Carolina Hospitals, Chapel Hill, NC
Official's Role
Principal Investigator
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8376
Country
United States
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0212
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5190
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19129
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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

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