Safety and Efficacy of 2 Treatment Regimens of Aztreonam for Inhalation Solution in Children With Cystic Fibrosis and New Onset Pseudomonas Aeruginosa Infection



Status:Recruiting
Conditions:Infectious Disease, Pulmonary, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any - 18
Updated:3/23/2019
Start Date:November 28, 2017
End Date:June 2021
Contact:Gilead Clinical Study Information Center
Email:GileadClinicalTrials@gilead.com
Phone:1-833-445-3230 (GILEAD-0)

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Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects With Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas Aeruginosa (PA) Infection/Colonization

The primary objective of this study is to evaluate the safety and efficacy of a 14-day course
versus a 28-day course of aztreonam for inhalation solution (AZLI) in participants with new
onset Pseudomonas aeruginosa respiratory tract infection.


Key Inclusion Criteria:

- Diagnosis of Cystic Fibrosis (CF) as determined by the 2008 CF Consensus Conference
criteria: Sweat chloride level ≥ 60 milliequivalents per liter (mEq/L) by quantitative
pilocarpine iontophoresis; or a genotype with 2 identifiable mutations consistent with
CF; or an abnormal nasal transepithelial potential difference (NPD), and 1 or more
clinical features consistent with CF

- Documented new onset of positive respiratory tract culture for PA within 30 days of
screening defined as either first lifetime documented PA-positive culture, or PA
recovered after at least a 2-year history of PA-negative respiratory cultures (at
least 2 cultures per year)

- Forced expiratory volume in one second (FEV1) ≥ 80% predicted (for subjects ≥ 6 years
of age who can reliably perform spirometry assessments)

- Clinically stable with no evidence of acute significant respiratory symptoms that
would require administration of IV antipseudomonal antibiotics, oxygen
supplementation, or hospitalization

Key Exclusion Criteria:

- Use of IV or inhaled antipseudomonal antibiotics within 2 years of screening

- Use of oral antipseudomonal antibiotics for a respiratory event within 30 days of
study entry (screening visit)

- History of intolerance to inhaled short acting β2 agonists

- History of lung transplantation

- Current requirement for daily continuous oxygen supplementation or requirement of more
than 2 L/minute at night

- Hospitalization for a respiratory event within 30 days prior to screening

- Changes in bronchodilator, corticosteroid, dornase alfa, or hypertonic saline
medications within 7 days prior to screening.

- Significant changes (per investigators discretion) in physiotherapy technique or
schedule within 7 days prior to screening

- Abnormal renal or hepatic function results at most recent test within the previous 12
months, defined as Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
> 5 times upper limit of normal (ULN), or Serum creatinine > 2 times ULN for age

- Presence of a condition or abnormality that would compromise the subject's safety or
the quality of the study data, in the opinion of the Investigator

- Known hypersensitivity to aztreonam, its metabolites, or formulation excipients in
AZLI

- Respiratory cultures performed within 24 months prior to screening that are positive
for ANY Burkholderia spp. or Non-tuberculous Mycobacteria (NTM)

Note: Other protocol defined Inclusion/Exclusion criteria may apply
We found this trial at
20
sites
2525 Chicago Avenue
Minneapolis, Minnesota 55404
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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598 Telfair Street
Augusta, Georgia 30912
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Charlotte, North Carolina 28277
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Charlotte, NC
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, Illinois 60637
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Hawthorne, New York 10532
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1600 Northwest 10th Avenue
Miami, Florida 33136
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601 5th Street South
Saint Petersburg, Florida 33701
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Shreveport, Louisiana 71130
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Ventura, California 93003
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Washington, District of Columbia 20010
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