Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans Syndrome
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ClinicalTrials.gov Identifier: NCT01287078 |
Recruitment Status :
Completed
First Posted : February 1, 2011
Results First Posted : September 24, 2020
Last Update Posted : September 24, 2020
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Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Constrictive Bronchiolitis Bronchiolitis Obliterans Graft vs Host Disease Bronchiolitis, Exudative Bronchiolitis, Proliferative |
Intervention |
Drug: Cyclosporine Inhalation Solution |
Enrollment | 25 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | Two subjects withdrew consent after signing |
Arm/Group Title | Inhaled Cyclosporine in HSCT Recipients | Inhaled Cyclosporine in Lung Transplant Recipients |
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Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19. | Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19. |
Period Title: Overall Study | ||
Started | 20 | 3 |
Completed | 10 | 1 |
Not Completed | 10 | 2 |
Baseline Characteristics
Arm/Group Title | Inhaled Cyclosporine in HSCT Recipients | Inhaled Cyclosporine in Lung Transplant Recipients | Total | |
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Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19. | Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19. | Total of all reporting groups | |
Overall Number of Baseline Participants | 20 | 3 | 23 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | 3 participants | 23 participants | |
<=18 years |
2 10.0%
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0 0.0%
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2 8.7%
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Between 18 and 65 years |
17 85.0%
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2 66.7%
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19 82.6%
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>=65 years |
1 5.0%
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1 33.3%
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2 8.7%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | 3 participants | 23 participants | |
Female |
8 40.0%
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2 66.7%
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10 43.5%
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Male |
12 60.0%
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1 33.3%
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13 56.5%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | 3 participants | 23 participants | |
Hispanic or Latino |
0 0.0%
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0 0.0%
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0 0.0%
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Not Hispanic or Latino |
20 100.0%
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3 100.0%
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23 100.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | 3 participants | 23 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
1 5.0%
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0 0.0%
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1 4.3%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
2 10.0%
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1 33.3%
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3 13.0%
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White |
16 80.0%
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2 66.7%
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18 78.3%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
1 5.0%
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0 0.0%
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1 4.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr Richard Childs |
Organization: | National Heart Lung and Blood Institute |
Phone: | 301-451-7128 |
EMail: | childsr@nhlbi.nih.gov |
Publications:
Responsible Party: | National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ) |
ClinicalTrials.gov Identifier: | NCT01287078 |
Other Study ID Numbers: |
110068 11-H-0068 |
First Submitted: | January 29, 2011 |
First Posted: | February 1, 2011 |
Results First Submitted: | August 3, 2020 |
Results First Posted: | September 24, 2020 |
Last Update Posted: | September 24, 2020 |