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Montelukast to Treat Bronchiolitis Obliterans

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ronald Gress, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00656058
First received: April 9, 2008
Last updated: August 29, 2016
Last verified: August 2016
Results First Received: August 29, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Bronchiolitis Obliterans
Chronic Graft Versus Host Disease
Leukotriene
Montelukast
Stem Cell Transplant
Intervention: Drug: Singular (Montelukast Sodium)

  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
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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
Montelukast to Treat Bronchiolitis Obliterans

Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.

Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS


Participant Flow:   Overall Study
    Montelukast to Treat Bronchiolitis Obliterans
STARTED   25 
COMPLETED   19 
NOT COMPLETED   6 
Withdrawal by Subject                2 
Withdrawal by Subject                4 



  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.
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Reporting Groups
  Description
Montelukast to Treat Bronchiolitis Obliterans

Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.

Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS


Baseline Measures
   Montelukast to Treat Bronchiolitis Obliterans 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Participants]
 
<=18 years   1 
Between 18 and 65 years   23 
>=65 years   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.29  (15.65) 
Gender 
[Units: Participants]
 
Female   14 
Male   11 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   1 
Not Hispanic or Latino   24 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   1 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   2 
White   22 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   25 


  Outcome Measures
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1.  Primary:   Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature   [ Time Frame: 180 days ]

2.  Primary:   Number of Participants With Improved, Stable or Declined Forced Expiratory Volume 1 (FEV-1) Slope at 6 Months   [ Time Frame: 180 days ]

3.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 71 months and 17 days ]

4.  Secondary:   Forced Expiratory Volume 1 (FEV-1)/Vital Capacity (VC)   [ Time Frame: Baseline ]

5.  Secondary:   Percentage Overall 2-Year Survival   [ Time Frame: 2 years ]

6.  Secondary:   Number of Non-Infected Participants at Baseline With Cysteinyl Leukotriene Receptor Expression on Cluster of Differentiation (CD4) and CD8 T Cells, Granulocytes, and Eosinophils in Bronchoalveolar Lavage (BAL) Fluid   [ Time Frame: Day 1 of study ]

7.  Secondary:   Timed Walk Test   [ Time Frame: 2 minutes and 6 minutes ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

8.  Secondary:   Forced Expiratory Flow 25-75 (FEF25-75) in Pediatric and Adult Patients Greater Than 6 Years With Bronchiolitis Obliterans   [ Time Frame: Baseline, 3 and 6 months on study, and 6 and 18 months post study drug ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

9.  Secondary:   Residual Volume (RV) in Pediatric and Adult Patients Greater Than 6 Years With Bronchiolitis Obliterans   [ Time Frame: Baseline, 3 month and 6 month on study, and 6 and 18 months post study drug. ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

10.  Secondary:   Carbon Monoxide Diffusing Capacity (DLC02) in Adults Only With Bronchiolitis Obliterans   [ Time Frame: Baseline, 3 month and 6 month on study, and 6 and 8 months post study drug ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

11.  Secondary:   Ratio of Forced Expiratory Volume 1 (FEV-1)/Forced Vital Capacity (FVC)   [ Time Frame: Baseline and 6 cycle pulmonary function tests ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

12.  Secondary:   Leukotriene Levels (LTB4 and Cysteinyl Leuotrienes (CysLT)) in the Urine Before and After Treatment   [ Time Frame: After cycle 3 and cycle 6 ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

13.  Secondary:   Leukotriene Levels (LTB4 and Cysteinyl Leukotrienes (CysLT)) in the Blood Before and After Treatment   [ Time Frame: Pretreatment and after cycle 3 and cycle 6 ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

14.  Secondary:   Leukotriene Receptor Expression (BLT or Cysteinyl Leukotrienes (CysLT)) on Activated Circulating Immune Cells Before and After Treatment   [ Time Frame: Pretreatment and after cycle 3 and cycle 6 ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

15.  Secondary:   Number of Participants With Chronic Graft Versus Host Disease (cGVHD) - Skin   [ Time Frame: Baseline, 3 month and 6 months on study, and 6 and 18 months post study drug. ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

16.  Secondary:   Quality of Life (QOL) Score at Baseline and Follow-up   [ Time Frame: Pretreatment, after cycles 3 and 6, and 6 and 18 months post study drug ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

17.  Secondary:   Residual Volume (RV/) Forced Vital Capacity (FVC) Measure (Adults Only)   [ Time Frame: Baseline, after 6 cycles, and 6 and 18 months post study drug ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No


  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: Dr. Ronald E. Gress
Organization: National Cancer Institute
phone: 301-496-1791
e-mail: gressr@dc10a.nci.nih.gov


Publications of Results:
Oral presentation: "Interim Analysis of a Phase II Trial of Montelukast for the Treatment of Bronchiolitis Obliterans Syndrome after HSCT reveal Immunobiology of Disease American Society of Blood and Marrow Transplantation 2013

Other Publications:

Responsible Party: Ronald Gress, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00656058     History of Changes
Other Study ID Numbers: 080097
08-C-0097
Study First Received: April 9, 2008
Results First Received: August 29, 2016
Last Updated: August 29, 2016
Health Authority: United States: Federal Government