Trial · NCT01307462
Targeted Therapy of Bronchiolitis Obliterans Syndrome
NCT01307462, Phase 2, Completed, Stephanie Lee; results first posted 2017-10-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Targeted Therapy of Bronchiolitis Obliterans Syndrome. Trials, record NCT01307462. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01307462
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Targeted Therapy of Bronchiolitis Obliterans Syndrome
- NCT number
- NCT01307462
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Stephanie Lee
- Conditions
- Bronchiolitis Obliterans
- Interventions
- fluticasone propionate, montelukast sodium, azithromycin
- First posted
- 2011-03-03
- Last updated
- 2017-10-04
- Results first posted
- 2017-10-04
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Who Failed Treatment | Within 3 months after initiation of study medications | Treatment failure is defined as sustained, absolute decrease (worsening) of the FEV1 by \>= 10% predicted in comparison to the baseline FEV1. Must be confirmed by a second PFT 2 weeks after the first measurement. |
| Secondary | Number of Subjects Who Experienced Grade 3-5 SAEs Attributable to FAM and Number of Subjects Who Stopped FAM as a Result | From baseline to 6 months | National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) (v4.0) |
| Secondary | Number of Subjects Who Experienced Statistically Significant Changes in FVC, TLC, RV, DLCO | Baseline and 6 months | |
| Secondary | Changes in Blood Molecular Markers: IL8 (Azithromycin), Cysteinyl and LTB4 (Monteleukast), and IL1B, TNF, and IL6, as Well as Neutrophil Count (Fluticasone) | Baseline to 6 months | |
| Secondary | Number of Subjects With Improvements in Other Chronic GVHD Characteristics | Baseline and 3 months | Only includes subjects who had complete or partial response according to the National Institute of Health (NIH) consensus criteria. |
| Secondary | Number of Subjects Were Able to Reduce Their Systemic Steroid Exposure by >=50% | Baseline to 6 months | |
| Secondary | Changes in Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36) | Baseline and 6 months | SF-36 subscales have min=0 and max=100; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome. |
| Secondary | Changes in Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT) | Baseline and 6 months | FACT-BMT subscales have various min/max, see below; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome. FACT physical well-being (0-28) FACT social/family well-being (0-28) FACT emotional well-being (0-24) FACT functional well-being (0-28) FACT Bone Marrow Transplant (BMT) subscale (0-40) FACT trial outcome index (0-96) FACT-General (G) (0-108) FACT-BMT total (0-148) |
| Secondary | Changes in Symptoms as Measured by Patient Self-report--Human Activities Profile (HAP) | Baseline and 6 months | HAP subscales have min=0 and max=94; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome. Maximum Activity Score (MAS) is highest item number answered still doing. Represents highest oxygen demanding activity that respondent still performs. Adjusted Activity Score (AAS) is MAS minus total number of stopped doing responses below MAS. A measure of usual daily activities. Modified AAS is MAS minus total number of stopped doing responses below MAS but not penalized for not doing activities not permitted post transplant. The following items are not counted against the score:11,15,19,20,22,25,34,41,42,47,49,50,52,53,54,57,72,73,77,78. |
| Secondary | Changes in Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale | Baseline and 6 months | Lee symptom scale (LSS) has subscales with min=0, max=100; results are given as change in 6mo score compared to baseline score, not actual score, and a negative change is correlated with improvement in clinical outcome. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Who Failed Treatment | Within 3 months after initiation of study medications | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Subjects Who Experienced Grade 3-5 SAEs Attributable to FAM and Number of Subjects Who Stopped FAM as a Result | From baseline to 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Subjects Who Experienced Statistically Significant Changes in FVC, TLC, RV, DLCO | Baseline and 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Changes in Blood Molecular Markers: IL8 (Azithromycin), Cysteinyl and LTB4 (Monteleukast), and IL1B, TNF, and IL6, as Well as Neutrophil Count (Fluticasone) | Baseline to 6 months | Data were not collected | ||
| SECONDARY | Number of Subjects With Improvements in Other Chronic GVHD Characteristics | Baseline and 3 months | 33 of 36 participants were evaluable at 3 months due to missing provider survey data | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Were Able to Reduce Their Systemic Steroid Exposure by >=50% | Baseline to 6 months | 24 out of 36 subjects were evaluable at 6mo due to missing data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Changes in Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36) | Baseline and 6 months | 24 of 36 subjects were evaluable at 6mo due to missing patient survey data. | units on a scale | MEDIAN |
| SECONDARY | Changes in Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT) | Baseline and 6 months | 24 of 36 subjects were evaluable at 6mo due to missing patient survey data. | units on a scale | MEDIAN |
| SECONDARY | Changes in Symptoms as Measured by Patient Self-report--Human Activities Profile (HAP) | Baseline and 6 months | 24 of 36 subjects were evaluable at 6mo due to missing patient survey data. | units on a scale | MEDIAN |
| SECONDARY | Changes in Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale | Baseline and 6 months | 24 of 36 subjects were evaluable at 6mo due to missing patient survey data. | units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Who Failed Treatment | Treatment (BOS Therapy) | 2 | Participants | ||
| Number of Subjects Who Experienced Grade 3-5 SAEs Attributable to FAM and Number of Subjects Who Stopped FAM as a Result | Treatment (BOS Therapy) | SAEs attributable to FAM | 11 | Participants | |
| Number of Subjects Who Experienced Grade 3-5 SAEs Attributable to FAM and Number of Subjects Who Stopped FAM as a Result | Treatment (BOS Therapy) | Stopped FAM during study | 1 | Participants | |
| Number of Subjects Who Experienced Statistically Significant Changes in FVC, TLC, RV, DLCO | Treatment (BOS Therapy) | 0 | Participants | ||
| Number of Subjects With Improvements in Other Chronic GVHD Characteristics | Treatment (BOS Therapy) | 12 | Participants | ||
| Number of Subjects Were Able to Reduce Their Systemic Steroid Exposure by >=50% | Treatment (BOS Therapy) | 17 | Participants | ||
| Changes in Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36) | Treatment (BOS Therapy) | SF-36 norm-based physical functioning score | 0.0 | Full Range -23.15 to 14.73 | units on a scale |
| Changes in Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36) | Treatment (BOS Therapy) | SF-36 norm-based role-physical score | 0.0 | Full Range -17.14 to 39.18 | units on a scale |
| Changes in Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36) | Treatment (BOS Therapy) | SF-36 norm-based bodily pain score | 0.0 | Full Range -13.52 to 17.33 | units on a scale |
| Changes in Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36) | Treatment (BOS Therapy) | SF-36 norm-based general health score | -2.38 | Full Range -20.02 to 17.64 | units on a scale |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (BOS Therapy) | 36 | |
| Overall Study | COMPLETED | Treatment (BOS Therapy) | 35 | |
| Overall Study | NOT COMPLETED | Treatment (BOS Therapy) | 1 |
Source ClinicalTrials.gov
Adverse events25
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 | Cavitary Pulmonary Lesion | Respiratory, thoracic and mediastinal disorders | Treatment (BOS Therapy) | 1 | 36 | 1 |
| other | Edema | General disorders | Treatment (BOS Therapy) | 1 | 36 | 1 |
| other | Alanine aminotransferase increased | Investigations | Treatment (BOS Therapy) | 1 | 36 | 1 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Treatment (BOS Therapy) | 1 | 36 | 1 |
| other | Hypertension | Vascular disorders | Treatment (BOS Therapy) | 1 | 36 | 1 |
| other | Lung infection | Respiratory, thoracic and mediastinal disorders | Treatment (BOS Therapy) | 1 | 36 | 1 |
| other | Rash maculopapular | Skin and subcutaneous tissue disorders | Treatment (BOS Therapy) | 1 | 36 | 1 |
| other | Thrombocytopenia | Investigations | Treatment (BOS Therapy) | 1 | 36 | 1 |
| other | Ventricular tachycardia | Cardiac disorders | Treatment (BOS Therapy) | 1 | 36 | 1 |
| serious | Edema limbs | General disorders | Treatment (BOS Therapy) | 1 | 36 | 1 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (BOS Therapy) | 1 | 36 |
| Total, other adverse events | Treatment (BOS Therapy) | 9 | 36 |
| Total, serious adverse events | Treatment (BOS Therapy) | 24 | 36 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U54CA163438 | Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplants (HCT) | LEE, STEPHANIE J | FRED HUTCHINSON CANCER RESEARCH CENTER | NATIONAL CANCER INSTITUTE | 2011 to 2014 |
Source NIH RePORTER
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/NCT01307462
GET https://conductscience.org/api/trials/v1/NCT01307462/results?page=2