Targeted Therapy of Bronchiolitis Obliterans Syndrome

Completed · Phase 2

Conditions studied: Bronchiolitis Obliterans

In brief

This phase II trial studies how well giving fluticasone propionate, azithromycin, and montelukast sodium (FAM) together works in treating patients with bronchiolitis obliterans who previously underwent stem cell transplant. FAM may be an effective treatment for bronchiolitis obliterans

Key facts

Study ID

NCT01307462

Run by

Stephanie Lee

People needed

36

Starts

2011-06-01

Expected to finish

2015-12-01

Last updated by the study team

2017-10-04

Who can join

Age: 6 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of BOS after HCT within the 6 months before study enrollment; for this study, BOS is defined as:
• Forced expiratory volume in 1 second (FEV1) < 75% of the predicted normal and FEV1 to slow or inspiratory vital capacity ratio (FEV1/SVC or FEV1/IVC) =< 0.7, both measured before and after administration of bronchodilator OR
• Pathologic diagnosis of BOS demonstrated by lung biopsy
• The baseline absolute FEV1 must be >= 10% lower than the pre-transplant absolute FEV1 as defined by the pre-transplant FEV1 minus the baseline FEV1, both measured before administration of a bronchodilator
• Participant (or parent/guardian) has the ability to understand and willingness to sign a written consent document

You may not qualify if…

• Recurrent or progressive malignancy requiring anticancer treatment
• Known history of allergy to or intolerance of montelukast, zafirlukast, azithromycin, erythromycin, or clarithromycin
• Pregnancy or nursing; all females of childbearing potential must have a negative serum or urine pregnancy test < 7 days before study drug administration
• Transaminases > 5 X upper limit of normal (ULN)
• Total bilirubin > 3 X ULN
• Chronic treatment with any inhaled steroid for > 1 month in the past three months
• Treatment with montelukast or zafirlukast for > 1 month during the past three months
• Treatment with prednisone at > 1.2 mg/kg/day (or equivalent steroid)
• Treatment with rifampin or phenobarbital, aspirin at doses > 325 mg/day, or ibuprofen at doses > 1200 mg/day
• Treatment with any Food and Drug Administration (FDA) non approved study medication within the past 4 weeks; off-label treatment with an FDA-approved medication is allowed
• Chronic oxygen therapy
• Evidence of any viral, bacterial or fungal infection involving the lung and not responding to appropriate treatment
• Clinical asthma (variable and recurring symptoms of airflow obstruction and bronchial hyper-responsiveness)
• Any condition that, in the opinion of the enrolling investigator, would interfere with the subject's ability to comply with the study requirements
• Uncontrolled substance abuse or psychiatric disorder
• Inability to perform pulmonary function tests (PFT) reliably, as determined by the enrolling investigator or PFT lab
• Life expectancy < 6 months at the time of enrollment as judged by the enrolling investigator
• Baseline post-bronchodilator FEV1 < 20% of predicted normal before or after albuterol

Where it is running

• Mayo Clinic - Scottsdale — Scottsdale, Arizona, United States
• Stanford University — Stanford, California, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• National Cancer Institute Experimental Transplantation & Immunology Branch — Bethesda, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States
• Siteman Cancer Center at Washington University — St Louis, Missouri, United States
• Weill Cornell Medical College — New York, New York, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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