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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
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Type Interventional
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
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
Hide Arm/Group Description 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
Arm/Group Title Inhaled Cyclosporine in HSCT Recipients Inhaled Cyclosporine in Lung Transplant Recipients Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 3 participants 23 participants
<=18 years
2
  10.0%
0
   0.0%
2
   8.7%
Between 18 and 65 years
17
  85.0%
2
  66.7%
19
  82.6%
>=65 years
1
   5.0%
1
  33.3%
2
   8.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 3 participants 23 participants
Female
8
  40.0%
2
  66.7%
10
  43.5%
Male
12
  60.0%
1
  33.3%
13
  56.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 3 participants 23 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
20
 100.0%
3
 100.0%
23
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 3 participants 23 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.0%
0
   0.0%
1
   4.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  10.0%
1
  33.3%
3
  13.0%
White
16
  80.0%
2
  66.7%
18
  78.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   5.0%
0
   0.0%
1
   4.3%
1.Primary Outcome
Title Overall Response to Treatment Based on Positive Response to Cyclosporine Inhalation Solution (CIS)
Hide Description Participants who responded to treatment with cyclosporine inhalation solution (CIS)
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses
Arm/Group Title Inhaled Cyclosporine in HSCT Recipients Inhaled Cyclosporine in Lung Transplant Recipients
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16 2
Measure Type: Count of Participants
Unit of Measure: Participants
9
  56.3%
0
   0.0%
2.Primary Outcome
Title Overall Non-response to Treatment
Hide Description Participants who did not respond to treatment with cyclosporine inhalation solution (CIS)
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses
Arm/Group Title Inhaled Cyclosporine in HSCT Recipients Inhaled Cyclosporine in Lung Transplant Recipients
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16 2
Measure Type: Count of Participants
Unit of Measure: Participants
7
  43.8%
2
 100.0%
3.Primary Outcome
Title Stable or Progressive Disease at Baseline With Improvement of FEV1
Hide Description Participants with stable or progressive disease at baseline with improvement of FEV1
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses
Arm/Group Title Inhaled Cyclosporine in HSCT Recipients Inhaled Cyclosporine in Lung Transplant Recipients
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16 2
Measure Type: Count of Participants
Unit of Measure: Participants
4
  25.0%
0
   0.0%
4.Primary Outcome
Title Disease Progression at Baseline With Stablization of FEV1
Hide Description Participants with progressive disease at baseline with stablization of FEV1
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses
Arm/Group Title Inhaled Cyclosporine in HSCT Recipients Inhaled Cyclosporine in Lung Transplant Recipients
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16 2
Measure Type: Count of Participants
Unit of Measure: Participants
2
  12.5%
0
   0.0%
5.Primary Outcome
Title Disease Stability at Baseline With Stablization in FEV1 and Greater Than 25% Decline in Systemic Immunosuppression
Hide Description Participants with stable disease at baseline with stablization in FEV1 and greater than 25% decline in systemic immunosuppression
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses
Arm/Group Title Inhaled Cyclosporine in HSCT Recipients Inhaled Cyclosporine in Lung Transplant Recipients
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16 2
Measure Type: Count of Participants
Unit of Measure: Participants
3
  18.8%
0
   0.0%
6.Primary Outcome
Title Stable or Progressive Disease at Baseline With Greater Than 20% of Decline in FEV1
Hide Description Participants with stable or progressive disease at baseline with greater than 20% of decline in FEV1
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses
Arm/Group Title Inhaled Cyclosporine in HSCT Recipients Inhaled Cyclosporine in Lung Transplant Recipients
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16 2
Measure Type: Count of Participants
Unit of Measure: Participants
1
   6.3%
0
   0.0%
7.Primary Outcome
Title Stable Disease at Baseline With Stablization of FEV1 and no Change or Increase in Systemic Immunosuppresion
Hide Description Participants with stable disease at baseline with stablization of FEV1 and no change or increase in systemic immunosuppresion
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses
Arm/Group Title Inhaled Cyclosporine in HSCT Recipients Inhaled Cyclosporine in Lung Transplant Recipients
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16 2
Measure Type: Count of Participants
Unit of Measure: Participants
4
  25.0%
2
 100.0%
8.Primary Outcome
Title Disease Progression at Baseline With Decline in FEV1 Greater Than 10%
Hide Description Participants with progressive disease at baseline with decline in FEV1 greater than 10%
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses
Arm/Group Title Inhaled Cyclosporine in HSCT Recipients Inhaled Cyclosporine in Lung Transplant Recipients
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16 2
Measure Type: Count of Participants
Unit of Measure: Participants
2
  12.5%
0
   0.0%
Time Frame 18 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Inhaled Cyclosporine in HSCT Recipients Inhaled Cyclosporine in Lung Transplant Recipients
Hide Arm/Group Description 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.
All-Cause Mortality
Inhaled Cyclosporine in HSCT Recipients Inhaled Cyclosporine in Lung Transplant Recipients
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/3 (0.00%) 
Hide Serious Adverse Events
Inhaled Cyclosporine in HSCT Recipients Inhaled Cyclosporine in Lung Transplant Recipients
Affected / at Risk (%) Affected / at Risk (%)
Total   5/20 (25.00%)   0/3 (0.00%) 
Blood and lymphatic system disorders     
Acute myeloid leukaemia recurrent   1/20 (5.00%)  0/3 (0.00%) 
Infections and infestations     
Enterovirus infection   1/20 (5.00%)  0/3 (0.00%) 
Pneumonia   2/20 (10.00%)  0/3 (0.00%) 
Rhinovirus infection   1/20 (5.00%)  0/3 (0.00%) 
Viral pericarditis   1/20 (5.00%)  0/3 (0.00%) 
Nervous system disorders     
Headache   1/20 (5.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea   1/20 (5.00%)  0/3 (0.00%) 
Hypoxia   1/20 (5.00%)  0/3 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Inhaled Cyclosporine in HSCT Recipients Inhaled Cyclosporine in Lung Transplant Recipients
Affected / at Risk (%) Affected / at Risk (%)
Total   18/20 (90.00%)   3/3 (100.00%) 
Blood and lymphatic system disorders     
Anaemia   1/20 (5.00%)  1/3 (33.33%) 
Lymphopenia   1/20 (5.00%)  0/3 (0.00%) 
Thrombocytopenia   1/20 (5.00%)  0/3 (0.00%) 
Cardiac disorders     
Chest pain   1/20 (5.00%)  0/3 (0.00%) 
Dizziness   1/20 (5.00%)  0/3 (0.00%) 
Dyspnoea   2/20 (10.00%)  0/3 (0.00%) 
Oedema peripheral   0/20 (0.00%)  1/3 (33.33%) 
Tachycardia   1/20 (5.00%)  0/3 (0.00%) 
Endocrine disorders     
Hypoglycaemia   1/20 (5.00%)  0/3 (0.00%) 
Eye disorders     
Dry Eye   1/20 (5.00%)  0/3 (0.00%) 
Gastrointestinal disorders     
Abdominal distension   1/20 (5.00%)  0/3 (0.00%) 
Diarrhoea   2/20 (10.00%)  1/3 (33.33%) 
Gastrooesophageal reflux disease   1/20 (5.00%)  0/3 (0.00%) 
Nausea   5/20 (25.00%)  1/3 (33.33%) 
Vomiting   3/20 (15.00%)  1/3 (33.33%) 
General disorders     
Fatigue   5/20 (25.00%)  0/3 (0.00%) 
Oedema   1/20 (5.00%)  0/3 (0.00%) 
Immune system disorders     
Graft versus host disease in eye   1/20 (5.00%)  0/3 (0.00%) 
Graft versus host disease in skin   1/20 (5.00%)  0/3 (0.00%) 
Infections and infestations     
Bronchitis   2/20 (10.00%)  0/3 (0.00%) 
Infection   1/20 (5.00%)  1/3 (33.33%) 
Influenza   1/20 (5.00%)  0/3 (0.00%) 
Lung infection   4/20 (20.00%)  3/3 (100.00%) 
Mycobacterium abscessus infection   1/20 (5.00%)  0/3 (0.00%) 
Pneumonia   1/20 (5.00%)  0/3 (0.00%) 
Skin infection   1/20 (5.00%)  0/3 (0.00%) 
Upper respiratory tract infection   3/20 (15.00%)  0/3 (0.00%) 
Urinary tract infection   1/20 (5.00%)  0/3 (0.00%) 
Injury, poisoning and procedural complications     
Fall   0/20 (0.00%)  1/3 (33.33%) 
Laceration   1/20 (5.00%)  0/3 (0.00%) 
Rib fracture   1/20 (5.00%)  0/3 (0.00%) 
Investigations     
Alanine aminotransferase increased   1/20 (5.00%)  1/3 (33.33%) 
Aspartate aminotransferase increased   1/20 (5.00%)  1/3 (33.33%) 
Blood alkaline phosphatase increased   1/20 (5.00%)  0/3 (0.00%) 
Blood creatine increased   0/20 (0.00%)  1/3 (33.33%) 
Blood creatinine increased   0/20 (0.00%)  1/3 (33.33%) 
Body temperature increased   3/20 (15.00%)  2/3 (66.67%) 
Electrocardiogram QT prolonged   0/20 (0.00%)  1/3 (33.33%) 
Forced expiratory volume decreased   0/20 (0.00%)  1/3 (33.33%) 
Hyperkalaemia   1/20 (5.00%)  0/3 (0.00%) 
Hypernatraemia   0/20 (0.00%)  1/3 (33.33%) 
Hypoalbuminaemia   0/20 (0.00%)  1/3 (33.33%) 
Lymphocyte count decreased   0/20 (0.00%)  1/3 (33.33%) 
Neck pain   1/20 (5.00%)  0/3 (0.00%) 
Weight decreased   1/20 (5.00%)  1/3 (33.33%) 
Metabolism and nutrition disorders     
Hyperkalaemia   2/20 (10.00%)  1/3 (33.33%) 
Hypernatraemia   0/20 (0.00%)  1/3 (33.33%) 
Hypoalbuminaemia   1/20 (5.00%)  1/3 (33.33%) 
Musculoskeletal and connective tissue disorders     
arthralgia   1/20 (5.00%)  0/3 (0.00%) 
Back pain   1/20 (5.00%)  0/3 (0.00%) 
Musculoskeletal chest pain   1/20 (5.00%)  1/3 (33.33%) 
Neck pain   1/20 (5.00%)  0/3 (0.00%) 
Nervous system disorders     
Dizziness   1/20 (5.00%)  0/3 (0.00%) 
Gait disturbance   0/20 (0.00%)  1/3 (33.33%) 
Headache   4/20 (20.00%)  1/3 (33.33%) 
Restlessness   0/20 (0.00%)  1/3 (33.33%) 
Somnolence   1/20 (5.00%)  0/3 (0.00%) 
Tremor   1/20 (5.00%)  0/3 (0.00%) 
Psychiatric disorders     
Depression   0/20 (0.00%)  1/3 (33.33%) 
Renal and urinary disorders     
Genitourinary symptom   1/20 (5.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm   8/20 (40.00%)  2/3 (66.67%) 
Chest discomfort   1/20 (5.00%)  0/3 (0.00%) 
Cough   15/20 (75.00%)  1/3 (33.33%) 
Dyspnoea   10/20 (50.00%)  2/3 (66.67%) 
Epistaxis   1/20 (5.00%)  0/3 (0.00%) 
Hypoxia   4/20 (20.00%)  1/3 (33.33%) 
Oxygen saturation decreased   1/20 (5.00%)  0/3 (0.00%) 
Rhinitis   1/20 (5.00%)  0/3 (0.00%) 
Rhinorrhoea   1/20 (5.00%)  0/3 (0.00%) 
Upper respiratory tract infection   1/20 (5.00%)  0/3 (0.00%) 
Vocal cord disorder   1/20 (5.00%)  0/3 (0.00%) 
Wheezing   1/20 (5.00%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders     
Erythema   0/20 (0.00%)  1/3 (33.33%) 
Hypertrichosis   1/20 (5.00%)  0/3 (0.00%) 
Vascular disorders     
Dizziness   2/20 (10.00%)  0/3 (0.00%) 
Hypertension   0/20 (0.00%)  2/3 (66.67%) 
Oedema   1/20 (5.00%)  0/3 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Richard Childs
Organization: National Heart Lung and Blood Institute
Phone: 301-451-7128
EMail: childsr@nhlbi.nih.gov
Layout table for additonal information
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