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Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)
This study is currently recruiting participants.
Verified by Gilead Sciences, December 2008
Sponsored by: Gilead Sciences
Information provided by: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00712166
  Purpose

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
Cystic Fibrosis
Lung Infection
Pseudomonas Aeruginosa
Drug: Aztreonam Lysine
Drug: Placebo
Phase III

Genetics Home Reference related topics: cystic fibrosis
MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Lysine Lysine acetate Lysine hydrochloride Aztreonam
U.S. FDA Resources
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)

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • The primary endpoint is change at Day 28 from baseline in the respiratory symptoms domain of the CFQ-R (cystic fibrosis questionnaire - revised). [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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
1: Experimental
75 mg aztreonam lysine three times daily for 28 days
Drug: Aztreonam Lysine
75 mg Aztreonam Lysine given three times daily for 28 days
2: Placebo Comparator
Placebo three times daily for 28 days
Drug: Placebo
Placebo three times daily for 28 days

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients ≥ 6 years of age.
  2. 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.

  3. PA present in expectorated sputum or throat swab culture at Visit 1 OR documented PA in 2 expectorated sputum or throat swab cultures within the 12 months prior to Visit 1. (One of the previous PA positive cultures must be no more than 3 months prior to Visit 1.)
  4. FEV1 > 75% predicted at Visit 1.
  5. 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

  6. Patients (and parent/guardian as required) must be able to provide written informed consent/assent prior to any study related procedures.
  7. Females of childbearing potential must have a negative urine pregnancy test at Visit 1.
  8. Ability to perform reproducible pulmonary function tests.
  9. In the opinion of the Investigator, the patient does not require immediate antipseudomonal antibiotic intervention to treat an impending exacerbation, and the patient's condition is stable enough to enroll in the study.

Exclusion Criteria:

  1. Administration of any investigational drug or device within 28 days prior to Visit 1 or within 6 half-lives of the investigational drug (whichever is longer).
  2. Administration of any IV, oral, or inhaled antipseudomonal antibiotic within 28 days prior to Visit 1.
  3. Known local or systemic hypersensitivity to monobactam antibiotics.
  4. Inability to tolerate short-acting bronchodilator use at least three times daily.
  5. Changes in or initiation of chronic azithromycin treatment within 28 days prior to Visit 1.
  6. Changes in or initiation of chronic hypertonic saline treatment within 28 days prior to Visit 1.
  7. Changes in or initiation of dornase alpha within 28 days prior to Visit 1.
  8. Changes in antimicrobial, bronchodilator (BD), or corticosteroid medications within 7 days prior to Visit 1.
  9. Changes in physiotherapy technique or schedule within 7 days prior to Visit 1.
  10. History of lung transplantation.
  11. History of participation (enrollment) in any prior clinical trials with AZLI.
  12. A chest radiograph at Visit 1 (or within the previous 180 days of Visit 1), with abnormalities indicating a significant acute finding (e.g., lobar infiltrate and atelectasis, pneumothorax, or pleural effusion). A chest radiograph obtained and interpreted between Visits 1 and 2 is also acceptable for determining eligibility.
  13. Positive urine pregnancy test at Visit 1; all women of childbearing potential will be tested.
  14. Females of childbearing potential who are lactating or are not (in the opinion of the investigator) practicing an acceptable method of birth control; female patients who utilize hormonal contraceptives as their birth control method must have used the same method for at least 3 months before study dosing.
  15. Patient is being assessed at Visit 1 by the investigator for an acute change in respiratory symptoms.
  16. Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patient treatment, assessment, or compliance with the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712166

Contacts
Contact: Crystal Green AZLI-CF@gilead.com

  Show 48 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
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
  More Information

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

Keywords provided by Gilead Sciences:
cystic fibrosis
pseudomonas aeruginosa
lung infection
CFQ-R
inhaled antibiotic
aztreonam lysine

Study placed in the following topic categories:
Aztreonam
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Pathologic Processes
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009