Trial · NCT00656058
Montelukast to Treat Bronchiolitis Obliterans
NCT00656058, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-10-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Montelukast to Treat Bronchiolitis Obliterans. Trials, record NCT00656058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00656058
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Montelukast to Treat Bronchiolitis Obliterans
- NCT number
- NCT00656058
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Bronchiolitis Obliterans, Chronic Graft Versus Host Disease, Leukotriene, Montelukast, Stem Cell Transplant
- Interventions
- Singulair (Montelukast Sodium)
- First posted
- 2008-04-10
- Last updated
- 2018-04-09
- Results first posted
- 2016-10-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature | 180 days | Responsive disease (RD) will be defined as ≥15% absolute improvement in the percentage predicted FEV-1. Progressive disease (PD) will be defined as \>15% decrease in FEV-1 documented on 2 pulmonary function test (PFT) evaluations greater than 2 weeks apart. Stable disease (SD) will be defined as \<15% change in the absolute FEV-1. |
| Primary | Number of Participants With Improved, Stable or Declined Forced Expiratory Volume 1 (FEV-1) Slope at 6 Months | 180 days | FEV-1 slope of decline was generated using regression line of FEV-1 value vs. days post hematopoietic stem cell transplant. Responsive disease (RD) for the slope of FEV-1 change will be an increase in the slope of absolute FEV-1. Progressive disease (PD) for the slope of FEV-1 change will be a decrease in the slope of absolute FEV-1. Stable disease (SD) for the slope of FEV-1 change will be a 0 change in FEV-1 slope. |
| Secondary | Number of Participants With Adverse Events | Date treatment consent signed to date off study, approximately 71 months and 17 days | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. |
| Secondary | Forced Expiratory Volume 1 (FEV-1)/Vital Capacity (VC) | Baseline | Pulmonary function test performed for eligibility and baseline. |
| Secondary | Percentage Overall 2-Year Survival | 2 years | Percentage of participants alive at 2 years. |
| 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 | Day 1 of study | Fluid from the bronchoalveolar lavage in adult participants (pediatric optional) will be collected and sent to the lab to be evaluated for infectious diseases by flow cytometry |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature | 180 days | No data is available for the one missing participant. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Improved, Stable or Declined Forced Expiratory Volume 1 (FEV-1) Slope at 6 Months | 180 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Adverse Events | Date treatment consent signed to date off study, approximately 71 months and 17 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Forced Expiratory Volume 1 (FEV-1)/Vital Capacity (VC) | Baseline | Ratio | MEDIAN | |
| SECONDARY | Percentage Overall 2-Year Survival | 2 years | This is a multicenter study and the number analyzed reflect data for evaluable subjects enrolled at the National Institutes of Health only. | percentage of participants | NUMBER |
| 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 | Day 1 of study | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature | Montelukast to Treat Bronchiolitis Obliterans | Increased 5-13% of predicted | 5 | Participants | |
| Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature | Montelukast to Treat Bronchiolitis Obliterans | Stable | 7 | Participants | |
| Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature | Montelukast to Treat Bronchiolitis Obliterans | Declined | 6 | Participants | |
| Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature | Montelukast to Treat Bronchiolitis Obliterans | Missing | 1 | Participants | |
| Number of Participants With Improved, Stable or Declined Forced Expiratory Volume 1 (FEV-1) Slope at 6 Months | Montelukast to Treat Bronchiolitis Obliterans | Improved | 9 | Participants | |
| Number of Participants With Improved, Stable or Declined Forced Expiratory Volume 1 (FEV-1) Slope at 6 Months | Montelukast to Treat Bronchiolitis Obliterans | Stable | 9 | Participants | |
| Number of Participants With Improved, Stable or Declined Forced Expiratory Volume 1 (FEV-1) Slope at 6 Months | Montelukast to Treat Bronchiolitis Obliterans | Declined | 1 | Participants | |
| Number of Participants With Adverse Events | Montelukast to Treat Bronchiolitis Obliterans | 20 | Participants | ||
| Forced Expiratory Volume 1 (FEV-1)/Vital Capacity (VC) | Montelukast to Treat Bronchiolitis Obliterans | 0.5 | Full Range 0.29 to 0.78 | Ratio | |
| Percentage Overall 2-Year Survival | Montelukast to Treat Bronchiolitis Obliterans | 84 | percentage of participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Montelukast to Treat Bronchiolitis Obliterans | 25 | |
| Overall Study | COMPLETED | Montelukast to Treat Bronchiolitis Obliterans | 19 | |
| Overall Study | NOT COMPLETED | Montelukast to Treat Bronchiolitis Obliterans | 6 |
Source ClinicalTrials.gov
Adverse events69
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Montelukast to Treat Bronchiolitis Obliterans | 4 | 25 | 5 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | Montelukast to Treat Bronchiolitis Obliterans | 4 | 25 | 5 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Montelukast to Treat Bronchiolitis Obliterans | 4 | 25 | 5 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | Montelukast to Treat Bronchiolitis Obliterans | 1 | 25 | 2 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Montelukast to Treat Bronchiolitis Obliterans | 2 | 25 | 3 |
| other | Edema: limb | Blood and lymphatic system disorders | Montelukast to Treat Bronchiolitis Obliterans | 1 | 25 | 1 |
| other | GGT (gamma-Glutamyl transpeptidase) | Metabolism and nutrition disorders | Montelukast to Treat Bronchiolitis Obliterans | 1 | 25 | 1 |
| other | Gastrointestinal - Other (Pneumatosis coli) | Gastrointestinal disorders | Montelukast to Treat Bronchiolitis Obliterans | 1 | 25 | 1 |
| other | Hemoglobin | Blood and lymphatic system disorders | Montelukast to Treat Bronchiolitis Obliterans | 2 | 25 | 2 |
| other | Hemorrhage, pulmonary/upper respiratory::Lung | Respiratory, thoracic and mediastinal disorders | Montelukast to Treat Bronchiolitis Obliterans | 1 | 25 | 2 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Montelukast to Treat Bronchiolitis Obliterans | 3 | 25 |
| Total, other adverse events | Montelukast to Treat Bronchiolitis Obliterans | 16 | 25 |
| Total, serious adverse events | Montelukast to Treat Bronchiolitis Obliterans | 15 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24419526 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00656058
GET https://conductscience.org/api/trials/v1/NCT00656058/events?page=2