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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00712166 |
The primary objective of this study is to assess the safety and efficacy of a 28-day course of aztreonam lysine for inhalation (AZLI) in patients with cystic fibrosis (CF), mild lung disease, FEV1 > 75% predicted (forced expiratory volume in one second), and Pseudomonas aeruginosa (PA).
Condition | Intervention | Phase |
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Cystic Fibrosis Lung Infection Pseudomonas Aeruginosa |
Drug: Aztreonam Lysine Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4) |
Estimated Enrollment: | 140 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
75 mg aztreonam lysine three times daily for 28 days
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Drug: Aztreonam Lysine
75 mg Aztreonam Lysine given three times daily for 28 days
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2: Placebo Comparator
Placebo three times daily for 28 days
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Drug: Placebo
Placebo three times daily for 28 days
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Ages Eligible for Study: | 6 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
i. Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT);
ii. Two well-characterized mutations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene; or
iii. Abnormal nasal potential difference.
Patient must exhibit two or more of the following chronic and/or intermittent CF symptoms, for a minimum of 28 days prior to randomization and with no worsening of symptoms within 7 days prior to randomization:
i. Chest congestion
ii. Daily cough
iii. Productive cough
iv. Wheezing
v. Trouble breathing
vi. Nocturnal wakening due to coughing
Exclusion Criteria:
Contact: Crystal Green | AZLI-CF@gilead.com |
Principal Investigator: | Claire Wainwright, MD | Royal Children's Hospital, Brisbane, QLD, Australia |
Principal Investigator: | Ron Gibson, MD | Children's Hospital & Regional Medical Center, Seattle WA, USA |
Responsible Party: | Gilead Sciences, Inc. ( Bruce Montgomery, MD/Medical Monitor ) |
Study ID Numbers: | GS-US-205-0117 |
Study First Received: | July 7, 2008 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00712166 |
Health Authority: | United States: Food and Drug Administration |
cystic fibrosis pseudomonas aeruginosa lung infection |
CFQ-R inhaled antibiotic aztreonam lysine |
Aztreonam Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Cystic fibrosis |
Anti-Infective Agents Anti-Bacterial Agents Pathologic Processes |
Therapeutic Uses Infection Pharmacologic Actions |