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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: June 6, 2017
Last verified: June 2017
Results First Received: August 29, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Bronchiolitis Obliterans
Chronic Graft Versus Host Disease
Leukotriene
Montelukast
Stem Cell Transplant
Intervention: Drug: Singulair (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]
Count of Participants
 
<=18 years      1   4.0% 
Between 18 and 65 years      23  92.0% 
>=65 years      1   4.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.29  (15.65) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      14  56.0% 
Male      11  44.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   4.0% 
Not Hispanic or Latino      24  96.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   4.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2   8.0% 
White      22  88.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
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 ]


  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: June 6, 2017