Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection
Primary Purpose
Cystic Fibrosis, Pseudomonas Aeruginosa Airway Infection
Status
Approved for marketing
Phase
Locations
International
Study Type
Expanded Access
Intervention
Aztreonam Lysine for Inhalation
Sponsored by
About this trial
This is an expanded access trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Pseudomonas aeruginosa, airway infection, Aztreonam Lysine for Inhalation
Eligibility Criteria
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
- ≥ 6 years of age
Subject has CF as diagnosed by one of the following:
- Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test
- Two well characterized genetic mutations in the CFTR gene
- Abnormal nasal potential difference with accompanying symptoms characteristic of CF
At high risk for disease progression as defined by one of the following subject populations:
First Cohort Criteria:
- Those who are wait listed or eligible for lung transplant based on FEV1 criteria. Patients who have a level of lung function impairment consistent with lung transplantation criteria, but who are ineligible for transplantation for other reasons, can enroll in this program; or
- Completed participation in CP-AI-006 (through Visit 20). Subjects who withdraw from CP-AI-006 prior to completing all courses of AZLI and all study visits will not be eligible for this protocol.
Second Cohort Criteria:
- Meets first cohort criteria
- FEV1 ≤ 40% predicted at the time of consent
Third Cohort Criteria:
- Meets first or second cohort criteria
- FEV1 ≤ 50% predicted at the time of consent
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
- Subjects with any serious or active medical or psychiatric illness that, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance with the protocol or dosing requirements
- Subjects with hypersensitivity to any of the components of the drug product
- Currently enrolled in another clinical trial
- Pregnant or lactating females
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00499720
Brief Title
Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection
Official Title
Expanded Access Program for Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression
Study Type
Expanded Access
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Gilead Sciences
4. Oversight
5. Study Description
Brief Summary
The primary objective of this program is to provide expanded access to aztreonam lysine for inhalation (AZLI) 75 mg prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P. aeruginosa airway infection who have limited treatment options and are at risk for disease progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Pseudomonas Aeruginosa Airway Infection
Keywords
Cystic Fibrosis, Pseudomonas aeruginosa, airway infection, Aztreonam Lysine for Inhalation
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aztreonam Lysine for Inhalation
Intervention Description
75 mg three times a day via inhalation for 28 days followed by 28 days off drug.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Eligibility Criteria
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
≥ 6 years of age
Subject has CF as diagnosed by one of the following:
Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test
Two well characterized genetic mutations in the CFTR gene
Abnormal nasal potential difference with accompanying symptoms characteristic of CF
At high risk for disease progression as defined by one of the following subject populations:
First Cohort Criteria:
Those who are wait listed or eligible for lung transplant based on FEV1 criteria. Patients who have a level of lung function impairment consistent with lung transplantation criteria, but who are ineligible for transplantation for other reasons, can enroll in this program; or
Completed participation in CP-AI-006 (through Visit 20). Subjects who withdraw from CP-AI-006 prior to completing all courses of AZLI and all study visits will not be eligible for this protocol.
Second Cohort Criteria:
Meets first cohort criteria
FEV1 ≤ 40% predicted at the time of consent
Third Cohort Criteria:
Meets first or second cohort criteria
FEV1 ≤ 50% predicted at the time of consent
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
Subjects with any serious or active medical or psychiatric illness that, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance with the protocol or dosing requirements
Subjects with hypersensitivity to any of the components of the drug product
Currently enrolled in another clinical trial
Pregnant or lactating females
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
City
Ft, Meyers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60302
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
54404
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89107
Country
United States
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208-3479
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7220
Country
United States
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43605
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
City
Ft. Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132-4701
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
City
San Juan
ZIP/Postal Code
366528
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection
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