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Trial record 1 of 1 for:    NCT01307462
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Targeted Therapy of Bronchiolitis Obliterans Syndrome (FAM for BOS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01307462
First Posted: March 3, 2011
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stephanie Lee, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Results First Submitted: January 20, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Bronchiolitis Obliterans
Interventions: Drug: fluticasone propionate
Drug: montelukast sodium
Drug: azithromycin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment (BOS Therapy) Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (BOS Therapy)
STARTED   36 
COMPLETED   35 
NOT COMPLETED   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment (BOS Therapy) Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.

Baseline Measures
   Treatment (BOS Therapy) 
Overall Participants Analyzed 
[Units: Participants]
 36 
Age 
[Units: Years]
Median (Full Range)
 57 
 (24 to 72) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      17  47.2% 
Male      19  52.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   2.8% 
Not Hispanic or Latino      35  97.2% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2   5.6% 
White      34  94.4% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects Who Failed Treatment   [ Time Frame: Within 3 months after initiation of study medications ]

2.  Secondary:   Number of Subjects Who Experienced Grade 3-5 SAEs Attributable to FAM and Number of Subjects Who Stopped FAM as a Result   [ Time Frame: From baseline to 6 months ]

3.  Secondary:   Number of Subjects Who Experienced Statistically Significant Changes in FVC, TLC, RV, DLCO   [ Time Frame: Baseline and 6 months ]

4.  Secondary:   Changes in Blood Molecular Markers: IL8 (Azithromycin), Cysteinyl and LTB4 (Monteleukast), and IL1B, TNF, and IL6, as Well as Neutrophil Count (Fluticasone)   [ Time Frame: Baseline to 6 months ]

5.  Secondary:   Number of Subjects With Improvements in Other Chronic GVHD Characteristics   [ Time Frame: Baseline and 3 months ]

6.  Secondary:   Number of Subjects Were Able to Reduce Their Systemic Steroid Exposure by >=50%   [ Time Frame: Baseline to 6 months ]

7.  Secondary:   Changes in Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)   [ Time Frame: Baseline and 6 months ]

8.  Secondary:   Changes in Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)   [ Time Frame: Baseline and 6 months ]

9.  Secondary:   Changes in Symptoms as Measured by Patient Self-report--Human Activities Profile (HAP)   [ Time Frame: Baseline and 6 months ]

10.  Secondary:   Changes in Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale   [ Time Frame: Baseline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Guang-Shing Cheng MD
Organization: FHCRC
phone: 206-667-7074
e-mail: gcheng2@fhcrc.org


Publications of Results:

Responsible Party: Stephanie Lee, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
ClinicalTrials.gov Identifier: NCT01307462     History of Changes
Other Study ID Numbers: 2367.00
NCI-2011-00203 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
U54CA163438 ( U.S. NIH Grant/Contract )
RDCRN 6503 ( Other Identifier: DMCC )
First Submitted: March 1, 2011
First Posted: March 3, 2011
Results First Submitted: January 20, 2017
Results First Posted: October 4, 2017
Last Update Posted: October 4, 2017