Cystic FibrosisNCT00499720
Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection
A study testing Aztreonam Lysine for Inhalation in people with Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection, run by Gilead Sciences at 65 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis, Pseudomonas Aeruginosa Airway Infection
- What is being tested?
- Aztreonam Lysine for Inhalation
- How many people
- Not given
- Where
- 65 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
65 sites in 2 countries.
65 sites in 2 countries
United States64 sites
Study site
Akron, Ohio, 44308
Study site
Albany, New York, 12208-3479
Study site
Albuquerque, New Mexico, 87131
Study site
Anchorage, Alaska, 99508
Study site
Birmingham, Alabama, 35233
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Boise, Idaho, 83712
Study site
Boston, Massachusetts, 02111
Study site
Boston, Massachusetts, 02114
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Buffalo, New York, 14222
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Chapel Hill, North Carolina, 27599-7220
Study site
Chicago, Illinois, 60302
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Chicago, Illinois, 60614
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Cincinnati, Ohio, 45229
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Cleveland, Ohio, 44106
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Columbia, Missouri, 65212
Study site
Columbus, Ohio, 43205
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Dallas, Texas, 75230
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Denver, Colorado, 80045
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Denver, Colorado, 80206
Study site
Des Moines, Iowa, 50309
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Detroit, Michigan, 48201
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Fort Worth, Texas, 76104
Study site
Ft, Meyers, Florida, 33908
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Gainesville, Florida, 32610
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Great Falls, Montana, 59405
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Hartford, Connecticut, 06102
Study site
Hartford, Connecticut, 06106
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Hershey, Pennsylvania, 17033
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Kansas City, Missouri, 64108
Study site
Las Vegas, Nevada, 89107
Study site
Little Rock, Arkansas, 72205
Study site
Long Branch, New Jersey, 07740
Study site
Los Angeles, California, 90027
Study site
Maywood, Illinois, 60153
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Memphis, Tennessee, 38103
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Minneapolis, Minnesota, 54404
Study site
Minneapolis, Minnesota, 55455
Study site
New Brunswick, New Jersey, 08901
Study site
New Hyde Park, New York, 11040
Study site
New Orleans, Louisiana, 70112
Study site
New York, New York, 10011
Study site
New York, New York, 10032
Study site
Norfolk, Virginia, 23507
Study site
Oklahoma City, Oklahoma, 73104
Study site
Orlando, Florida, 32803
Study site
Philadelphia, Pennsylvania, 19104
Study site
Philadelphia, Pennsylvania, 19134
Study site
Phoenix, Arizona, 85016
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Portsmouth, Virginia, 23708
Study site
Richmond, Virginia, 23219
Study site
Sacramento, California, 95819
Study site
Salt Lake City, Utah, 84132-4701
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San Antonio, Texas, 78212
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San Francisco, California, 94115
Study site
San Francisco, California, 94143
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Seattle, Washington, 98195
Study site
Sioux Falls, South Dakota, 57117
Study site
St. Petersburg, Florida, 33701
Study site
Syracuse, New York, 13210
Study site
Tampa, Florida, 33606
Study site
Toledo, Ohio, 43605
Study site
Valhalla, New York, 10595
Study site
Wichita, Kansas, 67214
About this study
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
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.
- Being tested
- Aztreonam Lysine for Inhalation
- Keywords
- Cystic Fibrosis, Pseudomonas aeruginosa, airway infection, Aztreonam Lysine for Inhalation
- Medical subject headings
- Cystic Fibrosis, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aztreonam Lysine for InhalationDrug
75 mg three times a day via inhalation for 28 days followed by 28 days off drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499720
- Sponsor's protocol ID
- EA-US-205-0111
- Status last verified
- Jul 2011
- First submitted
- 9 Jul 2007
- Last updated
- 2 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00499720
- Acronym / sponsor ID
- EA-US-205-0111
- Keywords
- Cystic Fibrosis, Pseudomonas aeruginosa, airway infection, Aztreonam Lysine for Inhalation
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- First posted
- 11 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- At high risk for disease progression as defined by one of the following subject populations:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aztreonam Lysine for Inhalation75 mg three times a day via inhalation for 28 days followed by 28 days off drug. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
65 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aztreonam Lysine for Inhalation in people with Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection, run by Gilead Sciences at 65 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2011.