Trial · NCT01273207
Extension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans
NCT01273207, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2020-09-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans. Trials, record NCT01273207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01273207
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans
- NCT number
- NCT01273207
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Bronchiolitis Obliterans, Constructive Bronchiolitis, Graft Versus Host Disease, Bronchiolitis, Exudative, Bronchiolitis, Proliferative, Graft-Versus-Host Disease
- Interventions
- Cyclosporine Inhalation Solution (CIS)
- First posted
- 2011-01-10
- Last updated
- 2020-09-18
- Results first posted
- 2020-09-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improvement in Lung Function - Increase in FEV1 | 6 Months | Continued improvement in lung function as defined by 10% or more increase in FEV1 |
| Primary | Disease Stablization - Decrease in FEV1 or Less Than 10% Increase in FEV1 | 6 Months | Stabilization in Pulmonary Function Test (PFT) as defined by less than 10% increase in FEV1 or less than 10% decline in FEV1 |
| Primary | Disease Progression - Decrease in FEV1 or Additional/Increase in Immunosuppressive Therapies | 6 Months | Disease progression as defined by a 20% or more decline in FEV1, or those who require an increase in immunosuppressive therapies by at least 25% or the addition of new immunosuppressive therapies. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Improvement in Lung Function - Increase in FEV1 | 6 Months | Inhaled Cyclosporine in hematopoietic stem cell transplant (HSCT) participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Disease Stablization - Decrease in FEV1 or Less Than 10% Increase in FEV1 | 6 Months | Inhaled Cyclosporine in hematopoietic stem cell transplant (HSCT) participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Disease Progression - Decrease in FEV1 or Additional/Increase in Immunosuppressive Therapies | 6 Months | Inhaled Cyclosporine in hematopoietic stem cell transplant (HSCT) participants | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Improvement in Lung Function - Increase in FEV1 | Inhaled Cyclosporine in HSCT Participants | 0 | Participants | ||
| Disease Stablization - Decrease in FEV1 or Less Than 10% Increase in FEV1 | Inhaled Cyclosporine in HSCT Participants | 7 | Participants | ||
| Disease Progression - Decrease in FEV1 or Additional/Increase in Immunosuppressive Therapies | Inhaled Cyclosporine in HSCT Participants | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Inhaled Cyclosporine in HSCT Participants | 7 | |
| Overall Study | COMPLETED | Inhaled Cyclosporine in HSCT Participants | 2 | |
| Overall Study | NOT COMPLETED | Inhaled Cyclosporine in HSCT Participants | 5 |
Source ClinicalTrials.gov
Adverse events29
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 | Haemoglobinaemia | Blood and lymphatic system disorders | Inhaled Cyclosporine in HSCT Participants | 2 | 7 | |
| other | Oedema peripheral | Cardiac disorders | Inhaled Cyclosporine in HSCT Participants | 2 | 7 | |
| other | Cataract | Eye disorders | Inhaled Cyclosporine in HSCT Participants | 1 | 7 | |
| other | Dry eye | Eye disorders | Inhaled Cyclosporine in HSCT Participants | 1 | 7 | |
| other | Nausea | Gastrointestinal disorders | Inhaled Cyclosporine in HSCT Participants | 1 | 7 | |
| other | Fatigue | General disorders | Inhaled Cyclosporine in HSCT Participants | 3 | 7 | |
| other | Oedema | General disorders | Inhaled Cyclosporine in HSCT Participants | 1 | 7 | |
| other | Influenza | Infections and infestations | Inhaled Cyclosporine in HSCT Participants | 1 | 7 | |
| other | Meningitis | Infections and infestations | Inhaled Cyclosporine in HSCT Participants | 1 | 7 | |
| other | Upper respiratory tract infection | Infections and infestations | Inhaled Cyclosporine in HSCT Participants | 3 | 7 |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Inhaled Cyclosporine in HSCT Participants | 1 | 7 |
| Total, other adverse events | Inhaled Cyclosporine in HSCT Participants | 7 | 7 |
| Total, serious adverse events | Inhaled Cyclosporine in HSCT Participants | 1 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01273207
GET https://conductscience.org/api/trials/v1/NCT01273207/events?page=2