Trial · NCT01287078
Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans Syndrome
NCT01287078, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2020-09-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans Syndrome. Trials, record NCT01287078. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01287078
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans Syndrome
- NCT number
- NCT01287078
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Constrictive Bronchiolitis, Bronchiolitis Obliterans, Graft vs Host Disease, Bronchiolitis, Exudative, Bronchiolitis, Proliferative
- Interventions
- Cyclosporine Inhalation Solution
- First posted
- 2011-02-01
- Last updated
- 2020-09-24
- Results first posted
- 2020-09-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response to Treatment Based on Positive Response to Cyclosporine Inhalation Solution (CIS) | 18 weeks | Participants who responded to treatment with cyclosporine inhalation solution (CIS) |
| Primary | Overall Non-response to Treatment | 18 weeks | Participants who did not respond to treatment with cyclosporine inhalation solution (CIS) |
| Primary | Stable or Progressive Disease at Baseline With Improvement of FEV1 | 18 weeks | Participants with stable or progressive disease at baseline with improvement of FEV1 |
| Primary | Disease Progression at Baseline With Stablization of FEV1 | 18 weeks | Participants with progressive disease at baseline with stablization of FEV1 |
| Primary | Disease Stability at Baseline With Stablization in FEV1 and Greater Than 25% Decline in Systemic Immunosuppression | 18 weeks | Participants with stable disease at baseline with stablization in FEV1 and greater than 25% decline in systemic immunosuppression |
| Primary | Stable or Progressive Disease at Baseline With Greater Than 20% of Decline in FEV1 | 18 weeks | Participants with stable or progressive disease at baseline with greater than 20% of decline in FEV1 |
| Primary | Stable Disease at Baseline With Stablization of FEV1 and no Change or Increase in Systemic Immunosuppresion | 18 weeks | Participants with stable disease at baseline with stablization of FEV1 and no change or increase in systemic immunosuppresion |
| Primary | Disease Progression at Baseline With Decline in FEV1 Greater Than 10% | 18 weeks | Participants with progressive disease at baseline with decline in FEV1 greater than 10% |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response to Treatment Based on Positive Response to Cyclosporine Inhalation Solution (CIS) | 18 weeks | Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Non-response to Treatment | 18 weeks | Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Stable or Progressive Disease at Baseline With Improvement of FEV1 | 18 weeks | Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Disease Progression at Baseline With Stablization of FEV1 | 18 weeks | Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Disease Stability at Baseline With Stablization in FEV1 and Greater Than 25% Decline in Systemic Immunosuppression | 18 weeks | Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Stable or Progressive Disease at Baseline With Greater Than 20% of Decline in FEV1 | 18 weeks | Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Stable Disease at Baseline With Stablization of FEV1 and no Change or Increase in Systemic Immunosuppresion | 18 weeks | Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Disease Progression at Baseline With Decline in FEV1 Greater Than 10% | 18 weeks | Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response to Treatment Based on Positive Response to Cyclosporine Inhalation Solution (CIS) | Inhaled Cyclosporine in HSCT Recipients | 9 | Participants | ||
| Overall Response to Treatment Based on Positive Response to Cyclosporine Inhalation Solution (CIS) | Inhaled Cyclosporine in Lung Transplant Recipients | 0 | Participants | ||
| Overall Non-response to Treatment | Inhaled Cyclosporine in HSCT Recipients | 7 | Participants | ||
| Overall Non-response to Treatment | Inhaled Cyclosporine in Lung Transplant Recipients | 2 | Participants | ||
| Stable or Progressive Disease at Baseline With Improvement of FEV1 | Inhaled Cyclosporine in HSCT Recipients | 4 | Participants | ||
| Stable or Progressive Disease at Baseline With Improvement of FEV1 | Inhaled Cyclosporine in Lung Transplant Recipients | 0 | Participants | ||
| Disease Progression at Baseline With Stablization of FEV1 | Inhaled Cyclosporine in HSCT Recipients | 2 | Participants | ||
| Disease Progression at Baseline With Stablization of FEV1 | Inhaled Cyclosporine in Lung Transplant Recipients | 0 | Participants | ||
| Disease Stability at Baseline With Stablization in FEV1 and Greater Than 25% Decline in Systemic Immunosuppression | Inhaled Cyclosporine in HSCT Recipients | 3 | Participants | ||
| Disease Stability at Baseline With Stablization in FEV1 and Greater Than 25% Decline in Systemic Immunosuppression | Inhaled Cyclosporine in Lung Transplant Recipients | 0 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Inhaled Cyclosporine in HSCT Recipients | 20 | |
| Overall Study | STARTED | Inhaled Cyclosporine in Lung Transplant Recipients | 3 | |
| Overall Study | COMPLETED | Inhaled Cyclosporine in HSCT Recipients | 10 | |
| Overall Study | COMPLETED | Inhaled Cyclosporine in Lung Transplant Recipients | 1 | |
| Overall Study | NOT COMPLETED | Inhaled Cyclosporine in HSCT Recipients | 10 | |
| Overall Study | NOT COMPLETED | Inhaled Cyclosporine in Lung Transplant Recipients | 2 |
Source ClinicalTrials.gov
Adverse events170
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 | Anaemia | Blood and lymphatic system disorders | Inhaled Cyclosporine in HSCT Recipients | 1 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Inhaled Cyclosporine in Lung Transplant Recipients | 1 | 3 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Inhaled Cyclosporine in HSCT Recipients | 1 | 20 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Inhaled Cyclosporine in Lung Transplant Recipients | 0 | 3 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Inhaled Cyclosporine in HSCT Recipients | 1 | 20 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Inhaled Cyclosporine in Lung Transplant Recipients | 0 | 3 | |
| other | Chest pain | Cardiac disorders | Inhaled Cyclosporine in HSCT Recipients | 1 | 20 | |
| other | Chest pain | Cardiac disorders | Inhaled Cyclosporine in Lung Transplant Recipients | 0 | 3 | |
| other | Dizziness | Cardiac disorders | Inhaled Cyclosporine in HSCT Recipients | 1 | 20 | |
| other | Dizziness | Cardiac disorders | Inhaled Cyclosporine in Lung Transplant Recipients | 0 | 3 |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Inhaled Cyclosporine in HSCT Recipients | 0 | 20 |
| Total, all-cause mortality | Inhaled Cyclosporine in Lung Transplant Recipients | 0 | 3 |
| Total, other adverse events | Inhaled Cyclosporine in HSCT Recipients | 18 | 20 |
| Total, other adverse events | Inhaled Cyclosporine in Lung Transplant Recipients | 3 | 3 |
| Total, serious adverse events | Inhaled Cyclosporine in HSCT Recipients | 5 | 20 |
| Total, serious adverse events | Inhaled Cyclosporine in Lung Transplant Recipients | 0 | 3 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Inhaled Cyclosporine in HSCT Recipients vs Inhaled Cyclosporine in Lung Transplant Recipients: Stable or Progressive Disease at Baseline With Improvement of FEV1 | Trial comparisons |
| Inhaled Cyclosporine in HSCT Recipients vs Inhaled Cyclosporine in Lung Transplant Recipients: Stable or Progressive Disease at Baseline With Greater Than 20% of Decline in FEV1 | Trial comparisons |
| Inhaled Cyclosporine in HSCT Recipients vs Inhaled Cyclosporine in Lung Transplant Recipients: Disease Progression at Baseline With Stablization of FEV1 | Trial comparisons |
Inhaled Cyclosporine in HSCT Recipients vs Inhaled Cyclosporine in Lung Transplant Recipients: Disease Stability at Baseline With Stablization in FEV1 and Greater Than 25% Decline in Systemic Immunosuppression | Trial comparisons |
Inhaled Cyclosporine in HSCT Recipients vs Inhaled Cyclosporine in Lung Transplant Recipients: Stable Disease at Baseline With Stablization of FEV1 and no Change or Increase in Systemic Immunosuppresion | Trial comparisons |
| Inhaled Cyclosporine in HSCT Recipients vs Inhaled Cyclosporine in Lung Transplant Recipients: Disease Progression at Baseline With Decline in FEV1 Greater Than 10% | Trial comparisons |
| Inhaled Cyclosporine in HSCT Recipients vs Inhaled Cyclosporine in Lung Transplant Recipients: Overall Response to Treatment Based on Positive Response to Cyclosporine Inhalation Solution (CIS) | Trial comparisons |
| Inhaled Cyclosporine in HSCT Recipients vs Inhaled Cyclosporine in Lung Transplant Recipients: deaths from any cause | Trial comparisons |
| Inhaled Cyclosporine in HSCT Recipients vs Inhaled Cyclosporine in Lung Transplant Recipients: Overall Non-response to Treatment | Trial comparisons |
| Inhaled Cyclosporine in HSCT Recipients vs Inhaled Cyclosporine in Lung Transplant Recipients: serious adverse events | Trial comparisons |
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/NCT01287078
GET https://conductscience.org/api/trials/v1/NCT01287078/events?page=2