Constrictive BronchiolitisPhase 2NCT01287078
Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans Syndrome
A Phase 2 study testing Cyclosporine Inhalation Solution in people with Constrictive Bronchiolitis and Bronchiolitis Obliterans, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Background: Bronchiolitis obliterans or bronchiolitis obliterans syndrome is a lung disorder that occurs as a complication of either lung transplantation or bone marrow/blood stem cell transplantation. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Constrictive Bronchiolitis, Bronchiolitis Obliterans, Graft vs Host Disease
- What is being tested?
- Cyclosporine Inhalation Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2011to 8 Aug 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History of:<TAB>
- -Hematopoietic stem cell transplant recipients at least 99 days post transplant (group A)
- Or
- Lung transplant recipients at least 6 months post transplant (Group B)
- Biopsy proven bronchiolitis obliterans (confirmed by NIH pathology department) or Bronchiolitis Obliterans Syndrome (BOS) as defined by:
- FEV1 less than 75 percent predicted and
Show all 19Show fewer
- No evidence of pulmonary infection as a causative etiology to lung dysfunction or other causative etiology
- Decline in FEV1 (The FEV1 values used to determine BOS will be the average of 2 measurements of FEV1 taken sequentially at least 3 weeks apart up to 6 months apart) compared to pre-transplant baseline for group A or compared to best post-transplant measurement in group B.
- For hematopoietic transplant patients, FEV1 must have declined less than 10 percent from pre-transplant baseline (group A)
- For lung transplant patients, FEV1 must have declined greater than 20 percent from best post-transplant measurement (group B)
- And one of the following:
- FEV1/FVC less than 0.7
- Air trapping seen on CT scan or RV greater than 20 percent predicted
- Evidence of cGVHD affecting at least one other organ system (group A)
- Age 10-80 years
- Progressive disease or stable disease (active BOS, stable by FEV1 criteria) on immunosuppressants at study entry
- Progressive disease at study entry: Diagnosis of BO or BOS with evidence of a progressive decline in FEV1. A documented decline (greater than or equal 10 percent) in FEV1 has occurred within 18 weeks (minimum documentation of 3 weeks) preceding study enrollment
- Stable disease at study entry: Diagnosis of BO or BOS on immunosuppressive therapy with evidence of stable disease (active BOS, stable by FEV1 criteria), as documented by a stable FEV1 (increase <5% and decrease <10%) within 18 weeks (minimum documentation of 3 weeks) preceding study enrollment
- Patients on calcineurin inhibitors at study entry will be required to be on a stable dose of the calcineurin inhibitor for 4 weeks prior to study enrollment
Who cannot join
- Evidence of uncontrolled, pulmonary infection
- Patients with unstable coronary insufficiency, severe cardiac arrhythmias, and/or uncontrolled hypertension.
- History of hypersensitivity to propylene glycol
- History of allergic reaction or hypersensitivity to Technetium- 99m sulfur colloid, used in lung deposition studies
- ECOG performance status greater than or equal to 3
- Serum creatinine >2.5 mg/dl
Show all 12Show fewer
- Documented allergy or intolerance to cyclosporine
- Patient pregnant or breast feeding or not willing to use an approved method of birth control
- Inability to comprehend the investigational nature of the study and provide informed consent
- Life expectancy less than 18 weeks.
- An increase greater than or equal to 5% and an absolute increase greater than or equal to 0.05 in FEV1 in the 18 weeks (minimum documentation of 3 weeks) preceding study enrollment
- Subjects who have had prior administration of inhaled cyclosporine.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Phase II Trial of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for Treatment of Bronchiolitis Obliterans Syndrome
Background:
- Bronchiolitis obliterans or bronchiolitis obliterans syndrome is a lung disorder that occurs as a complication of either lung transplantation or bone marrow/blood stem cell transplantation. One of the complications of transplant is the occurrence of graft versus host disease (in hematopoietic stem cell transplants) and host versus graft disease (in lung transplantation). In these diseases, the cells attack the lungs and cause irreversible small airway fibrosis referred to as bronchiolitis obliterans syndrome. When a patient develops fibrosis of the lungs or bronchioles, the lungs no longer work properly, which causes difficulties with breathing that lead to a diminished quality of life and an increased risk of death. Treatment typically involves immunosuppressive therapy such as oral cyclosporine or steroid therapy, but these treatments are only marginally effective and can cause significant toxicities and increase the risk of infections. Inhaled cyclosporine (CIS) achieves higher concentrations of cyclosporine in the lungs and lower concentrations of cyclosporine in the blood than oral cyclosporine. Therefore, it could have advantages over conventional oral immunosuppressive therapies used to treat this disorder. Researchers are interested in testing whether inhaled cyclosporine therapy could be used as a safe and effective treatment for bronchiolitis obliterans or bronchiolitis obliterans syndrome occurring after bone marrow/blood stem cell or lung transplants.
Read more
Objectives:
- To evaluate whether inhaled cyclosporine (CIS) can improve or stabilize lung function and quality of life in individuals with bronchiolitis obliterans.
Eligibility:
- Individuals between 10 and 80 years of age who have been diagnosed with bronchiolitis obliterans or bronchiolitis obliterans syndrome after blood or lung transplants.
Design:
- Participants will be screened with a full medical history and physical examination, as well as blood and urine tests, lung function tests, imaging studies, bronchoalveolar lavage samples, and quality of life questionnaires.
- Participants will take cyclosporine inhalation solution through a nebulizer. The nebulizer generates a mist of cyclosporine inhalation solution (CIS), which is then breathed in through a mouthpiece. The process takes approximately 20 minutes. The solution will be provided in single-use vials.
- Participants will continue to take all medications for post-transplant care as required by their doctor and the study researchers. Attempts will be made to reduce the doses and types of immunosuppressants given to participants on the study, as long as the treatment continues to produce improved or stable lung function.
- Participants will have study visits every 3 weeks with blood and urine tests, lung function tests, and imaging studies. Participants will undergo repeat bronchoalveolar sample at week 9 and 18. Participants will also complete quality of life questionnaires as directed. Treatment will continue for a minimum of 18 weeks, followed by a final follow-up visit 2 weeks after the end of the study.
- Participants who benefit from the inhaled cyclosporine (CIS) may continue to receive further therapy with inhaled cyclosporine at the end of the study by participation in a separate study extension.
Read the detailed description
Bronchiolitis Obliterans (BO) is an obstructive lung disease that can affect individuals that have undergone a lung or hematopoietic stem cell transplant. BO has been studied most extensively in lung transplant recipients, where it is considered to represent chronic lung rejection. It is the leading cause of death after lung transplant, with mortality rates up to 55%. In hematopoietic stem cell transplantation, BO is thought to be a manifestation of chronic graft-vs-host disease (GVHD). Up to 45% of patients undergoing hematopoietic stem cell transplantation at the NHLBI develop a decline in pulmonary function. Conventional therapy for patients who develop BO consists of augmentation of systemic immunosuppressants. Systemic immunosuppression has limited efficacy for BO and is associated with deleterious consequences including increased risk of infections and decreased graft-versus tumor/leukemia effects.
Recently, cyclosporine inhalation solution (CIS) in solution with propylene glycol has been shown to improve overall survival and chronic rejection-free survival in lung transplant patients. These findings suggest targeted delivery of immunosuppressive therapy to the diseased organ warrants further investigation as this may minimize the morbidity associated with systemic immunosuppression. However, there currently exists limited data regarding the overall efficacy of inhaled cyclosporine to treat established BO following lung transplantation. Furthermore, inhaled cyclosporine has not been studied in the treatment of BO following hematopoietic stem cell transplantation.
Here, we propose to evaluate the safety, efficacy, and pharmacodynamics of inhaled cyclosporine for the treatment of BO. Two distinct patient populations will be offered enrollment in this protocol: hematopoietic transplant recipients with BO (group A) and lung transplant recipients with BO (group B). Study participants will receive CIS at an initial dose of 150mg, three times weekly. Patients will undergo dose titration to a maximum dose of 300mg, three times weekly. Drug deposition and pharmacokinetic analyses will be performed at the initiation of treatment. Clinical parameters, including pulmonary function tests, will be measured in addition to laboratory markers of the anti-inflammatory response to CIS. Adverse events associated with treatment will be recorded.
The primary objective is to 1) assess the safety and efficacy of inhaled cyclosporine as a new therapy in hematopoietic transplant patients and lung transplant patients with established BO. Additionally, we seek to promote a better understanding of the pathogenesis of BO in these two transplant groups and to assess the anti-inflammatory effects of inhaled cyclosporine in patients that develop this complication.
The primary endpoint of each study group is the best response, FEV1 improvement or stabilization from study baseline at week 18 for two successive measures, at least 1 week apart, no more than 2 weeks apart. Secondary endpoints include the toxicity profile as measured by CTCAE criteria (safety), the study of pharmacokinetics and lung deposition characteristics of inhaled cyclosporine, improvement in high resolution chest CT images, results of peripheral blood and bronchoalveolar cytokine arrays to assess secondary markers of inflammation, and functional capacity measurements using a six-minute walk test.
- Conditions
- Constrictive Bronchiolitis, Bronchiolitis Obliterans, Graft vs Host Disease, Bronchiolitis, Exudative, Bronchiolitis, Proliferative
- Being tested
- Cyclosporine Inhalation Solution
- Keywords
- Peripheral Blood Stem Cell Transplant, Inhaled Cyclosporine, Graft-Versus-Host Disease, GVHD, Bronchiolitis Obliterans, Lung
- Medical subject headings
- Bronchiolitis Obliterans, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine Inhalation SolutionDrug
sterile, clear, colorless, preservative-free solution of cyclosporine (USP) in propylene glycol developed specifically for administration by oral inhalation.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Cyclosporine in Lung Transplant and HSCT Recipients | Experimental | Subjects with 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. Receives: Drug: Cyclosporine Inhalation Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response to Treatment Based on Positive Response to Cyclosporine Inhalation Solution (CIS)
Participants who responded to treatment with cyclosporine inhalation solution (CIS)
Measured: 18 weeks
Overall Non-response to Treatment
Participants who did not respond to treatment with cyclosporine inhalation solution (CIS)
Measured: 18 weeks
Stable or Progressive Disease at Baseline With Improvement of FEV1
Participants with stable or progressive disease at baseline with improvement of FEV1
Measured: 18 weeks
Disease Progression at Baseline With Stablization of FEV1
Participants with progressive disease at baseline with stablization of FEV1
Measured: 18 weeks
Disease Stability at Baseline With Stablization in FEV1 and Greater Than 25% Decline in Systemic Immunosuppression
Participants with stable disease at baseline with stablization in FEV1 and greater than 25% decline in systemic immunosuppression
Measured: 18 weeks
Stable or Progressive Disease at Baseline With Greater Than 20% of Decline in FEV1
Participants with stable or progressive disease at baseline with greater than 20% of decline in FEV1
Measured: 18 weeks
Stable Disease at Baseline With Stablization of FEV1 and no Change or Increase in Systemic Immunosuppresion
Participants with stable disease at baseline with stablization of FEV1 and no change or increase in systemic immunosuppresion
Measured: 18 weeks
Disease Progression at Baseline With Decline in FEV1 Greater Than 10%
Participants with progressive disease at baseline with decline in FEV1 greater than 10%
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study start29 Jan 2011
- Primary completion8 Aug 2018
- Study completion8 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Constrictive BronchiolitisStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nicole J Gormley, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287078
- Sponsor's protocol ID
- 110068
- Other IDs
- 11-H-0068
- Status last verified
- 31 Aug 2018
- First submitted
- 29 Jan 2011
- Last updated
- 24 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Afessa B, Litzow MR, Tefferi A. Bronchiolitis obliterans and other late onset non-infectious pulmonary complications in hematopoietic stem cell transplantation. Bone Marrow Transplant. 2001 Sep;28(5):425-34. doi: 10.1038/sj.bmt.1703142.
PubMed 11593314Boucek MM, Waltz DA, Edwards LB, Taylor DO, Keck BM, Trulock EP, Hertz MI; International Society for Heart and Lung Transplantation. Registry of the International Society for Heart and Lung Transplantation: ninth official pediatric heart transplantation report--2006. J Heart Lung Transplant. 2006 Aug;25(8):893-903. doi: 10.1016/j.healun.2006.05.014. No abstract available.
PubMed 16890109Savani BN, Montero A, Srinivasan R, Singh A, Shenoy A, Mielke S, Rezvani K, Karimpour S, Childs R, Barrett AJ. Chronic GVHD and pretransplantation abnormalities in pulmonary function are the main determinants predicting worsening pulmonary function in long-term survivors after stem cell transplantation. Biol Blood Marrow Transplant. 2006 Dec;12(12):1261-9. doi: 10.1016/j.bbmt.2006.07.016.
PubMed 17162207
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for Treatment of Bronchiolitis Obliterans Syndrome
- ClinicalTrials.gov ID
- NCT01287078
- Acronym / sponsor ID
- 110068
- Conditions
- Constrictive Bronchiolitis, Bronchiolitis Obliterans, Graft vs Host Disease, Bronchiolitis, Exudative, Bronchiolitis, Proliferative
- Keywords
- Peripheral Blood Stem Cell Transplant, Inhaled Cyclosporine, Graft-Versus-Host Disease, GVHD, Bronchiolitis Obliterans, Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 29 Jan 2011
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 8 Aug 2018 (actual)
- First posted
- 1 Feb 2011 (estimated)
- Results
- Posted 24 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Bronchiolitis obliterans or bronchiolitis obliterans syndrome is a lung disorder that occurs as a complication of either lung transplantation or bone marrow/blood stem cell transplantation. One of the complications of transplant is the occurrence of graft versus host disease (in hematopoietic stem cell transplants) and host versus graft disease (in lung transplantation). In these diseases, the cells attack the lungs and cause irreversible small airway fibrosis referred to as bronchiolitis obliterans syndrome. When a patient develops fibrosis of the lungs or bronchioles, the lungs no longer work properly, which causes difficulties with breathing that lead to a diminished quality of life and an increased risk of death. Treatment typically involves immunosuppressive therapy such as oral cyclosporine or steroid therapy, but these treatments are only marginally effective and can cause significant toxicities and increase the risk of infections. Inhaled cyclosporine (CIS) achieves higher concentrations of cyclosporine in the lungs and lower concentrations of cyclosporine in the blood than oral cyclosporine. Therefore, it could have advantages over conventional oral immunosuppressive therapies used to treat this disorder. Researchers are interested in testing whether inhaled cyclosporine therapy could be used as a safe and effective treatment for bronchiolitis obliterans or bronchiolitis obliterans syndrome occurring after bone marrow/blood stem cell or lung transplants.
Objectives:
- To evaluate whether inhaled cyclosporine (CIS) can improve or stabilize lung function and quality of life in individuals with bronchiolitis obliterans.
Eligibility:
- Individuals between 10 and 80 years of age who have been diagnosed with bronchiolitis obliterans or bronchiolitis obliterans syndrome after blood or lung transplants.
Design:
- Participants will be screened with a full medical history and physical examination, as well as blood and urine tests, lung function tests, imaging studies, bronchoalveolar lavage samples, and quality of life questionnaires.
- Participants will take cyclosporine inhalation solution through a nebulizer. The nebulizer generates a mist of cyclosporine inhalation solution (CIS), which is then breathed in through a mouthpiece. The process takes approximately 20 minutes. The solution will be provided in single-use vials.
- Participants will continue to take all medications for post-transplant care as required by their doctor and the study researchers. Attempts will be made to reduce the doses and types of immunosuppressants given to participants on the study, as long as the treatment continues to produce improved or stable lung function.
- Participants will have study visits every 3 weeks with blood and urine tests, lung function tests, and imaging studies. Participants will undergo repeat bronchoalveolar sample at week 9 and 18. Participants will also complete quality of life questionnaires as directed. Treatment will continue for a minimum of 18 weeks, followed by a final follow-up visit 2 weeks after the end of the study.
- Participants who benefit from the inhaled cyclosporine (CIS) may continue to receive further therapy with inhaled cyclosporine at the end of the study by participation in a separate study extension.
Detailed description
Bronchiolitis Obliterans (BO) is an obstructive lung disease that can affect individuals that have undergone a lung or hematopoietic stem cell transplant. BO has been studied most extensively in lung transplant recipients, where it is considered to represent chronic lung rejection. It is the leading cause of death after lung transplant, with mortality rates up to 55%. In hematopoietic stem cell transplantation, BO is thought to be a manifestation of chronic graft-vs-host disease (GVHD). Up to 45% of patients undergoing hematopoietic stem cell transplantation at the NHLBI develop a decline in pulmonary function. Conventional therapy for patients who develop BO consists of augmentation of systemic immunosuppressants. Systemic immunosuppression has limited efficacy for BO and is associated with deleterious consequences including increased risk of infections and decreased graft-versus tumor/leukemia effects.
Recently, cyclosporine inhalation solution (CIS) in solution with propylene glycol has been shown to improve overall survival and chronic rejection-free survival in lung transplant patients. These findings suggest targeted delivery of immunosuppressive therapy to the diseased organ warrants further investigation as this may minimize the morbidity associated with systemic immunosuppression. However, there currently exists limited data regarding the overall efficacy of inhaled cyclosporine to treat established BO following lung transplantation. Furthermore, inhaled cyclosporine has not been studied in the treatment of BO following hematopoietic stem cell transplantation.
Here, we propose to evaluate the safety, efficacy, and pharmacodynamics of inhaled cyclosporine for the treatment of BO. Two distinct patient populations will be offered enrollment in this protocol: hematopoietic transplant recipients with BO (group A) and lung transplant recipients with BO (group B). Study participants will receive CIS at an initial dose of 150mg, three times weekly. Patients will undergo dose titration to a maximum dose of 300mg, three times weekly. Drug deposition and pharmacokinetic analyses will be performed at the initiation of treatment. Clinical parameters, including pulmonary function tests, will be measured in addition to laboratory markers of the anti-inflammatory response to CIS. Adverse events associated with treatment will be recorded.
The primary objective is to 1) assess the safety and efficacy of inhaled cyclosporine as a new therapy in hematopoietic transplant patients and lung transplant patients with established BO. Additionally, we seek to promote a better understanding of the pathogenesis of BO in these two transplant groups and to assess the anti-inflammatory effects of inhaled cyclosporine in patients that develop this complication.
The primary endpoint of each study group is the best response, FEV1 improvement or stabilization from study baseline at week 18 for two successive measures, at least 1 week apart, no more than 2 weeks apart. Secondary endpoints include the toxicity profile as measured by CTCAE criteria (safety), the study of pharmacokinetics and lung deposition characteristics of inhaled cyclosporine, improvement in high resolution chest CT images, results of peripheral blood and bronchoalveolar cytokine arrays to assess secondary markers of inflammation, and functional capacity measurements using a six-minute walk test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inhaled Cyclosporine in Lung Transplant and HSCT Recipients | Experimental | Drug: Cyclosporine Inhalation SolutionSubjects with 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. |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- History of:<TAB>
- -Hematopoietic stem cell transplant recipients at least 99 days post transplant (group A)
- Or
- Lung transplant recipients at least 6 months post transplant (Group B)
- Biopsy proven bronchiolitis obliterans (confirmed by NIH pathology department) or Bronchiolitis Obliterans Syndrome (BOS) as defined by:
Key exclusion criteria (12 listed)
- Evidence of uncontrolled, pulmonary infection
- Patients with unstable coronary insufficiency, severe cardiac arrhythmias, and/or uncontrolled hypertension.
- History of hypersensitivity to propylene glycol
- History of allergic reaction or hypersensitivity to Technetium- 99m sulfur colloid, used in lung deposition studies
- ECOG performance status greater than or equal to 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporine Inhalation Solutionsterile, clear, colorless, preservative-free solution of cyclosporine (USP) in propylene glycol developed specifically for administration by oral inhalation. | Drug | Inhaled Cyclosporine in Lung Transplant and HSCT Recipients |
Primary outcome
Overall Response to Treatment Based on Positive Response to Cyclosporine Inhalation Solution (CIS)
Time frame: 18 weeks
Participants who responded to treatment with cyclosporine inhalation solution (CIS)
Overall Non-response to Treatment
Time frame: 18 weeks
Participants who did not respond to treatment with cyclosporine inhalation solution (CIS)
Stable or Progressive Disease at Baseline With Improvement of FEV1
Time frame: 18 weeks
Participants with stable or progressive disease at baseline with improvement of FEV1
Disease Progression at Baseline With Stablization of FEV1
Time frame: 18 weeks
Participants with progressive disease at baseline with stablization of FEV1
Disease Stability at Baseline With Stablization in FEV1 and Greater Than 25% Decline in Systemic Immunosuppression
Time frame: 18 weeks
Participants with stable disease at baseline with stablization in FEV1 and greater than 25% decline in systemic immunosuppression
Stable or Progressive Disease at Baseline With Greater Than 20% of Decline in FEV1
Time frame: 18 weeks
Participants with stable or progressive disease at baseline with greater than 20% of decline in FEV1
Stable Disease at Baseline With Stablization of FEV1 and no Change or Increase in Systemic Immunosuppresion
Time frame: 18 weeks
Participants with stable disease at baseline with stablization of FEV1 and no change or increase in systemic immunosuppresion
Disease Progression at Baseline With Decline in FEV1 Greater Than 10%
Time frame: 18 weeks
Participants with progressive disease at baseline with decline in FEV1 greater than 10%
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11593314Afessa B, Litzow MR, Tefferi A. Bronchiolitis obliterans and other late onset non-infectious pulmonary complications in hematopoietic stem cell transplantation. Bone Marrow Transplant. 2001 Sep;28(5):425-34. doi: 10.1038/sj.bmt.1703142.
- Background: PubMed 16890109Boucek MM, Waltz DA, Edwards LB, Taylor DO, Keck BM, Trulock EP, Hertz MI; International Society for Heart and Lung Transplantation. Registry of the International Society for Heart and Lung Transplantation: ninth official pediatric heart transplantation report--2006. J Heart Lung Transplant. 2006 Aug;25(8):893-903. doi: 10.1016/j.healun.2006.05.014. No abstract available.
- Background: PubMed 17162207Savani BN, Montero A, Srinivasan R, Singh A, Shenoy A, Mielke S, Rezvani K, Karimpour S, Childs R, Barrett AJ. Chronic GVHD and pretransplantation abnormalities in pulmonary function are the main determinants predicting worsening pulmonary function in long-term survivors after stem cell transplantation. Biol Blood Marrow Transplant. 2006 Dec;12(12):1261-9. doi: 10.1016/j.bbmt.2006.07.016.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole J Gormley, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclosporine Inhalation Solution in people with Constrictive Bronchiolitis and Bronchiolitis Obliterans, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response to Treatment Based on Positive Response to Cyclosporine Inhalation Solution (CIS) (time frame: 18 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01287078, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.