The Efficacy and Safety of Sirolimus for Plastic Bronchitis
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|ClinicalTrials.gov Identifier: NCT03942926|
Recruitment Status : Unknown
Verified May 2019 by Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : May 8, 2019
Last Update Posted : May 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Plastic Bronchitis||Drug: Sirolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Ten lymphatic bronchitis patients are planned to be recruited for the study. Sirolimus will be administered for 6 months.|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy and Safety of Sirolimus for Plastic Bronchitis：a Pilot Study|
|Estimated Study Start Date :||May 6, 2019|
|Estimated Primary Completion Date :||May 5, 2020|
|Estimated Study Completion Date :||May 5, 2020|
Patients in sirolimus group will receive sirolimus for 6 months.
Patients will receive sirolimus for 6 months.
Other Name: rapamycin
- changes of pulmonary lymphatic perfusion distribution [ Time Frame: 6 months ]quantitatively measured with 68Ga-NEB positron emission tomography (PET) at baseline and the end of study
- changes of coughing score [ Time Frame: 6 months ]measured by coughing VAS score (0-10) at baseline, 3 months and the end of study
- changes of pulmonary function (FEV1, FVC) [ Time Frame: 6 months ]measured by spirometry at baseline, 3 months and the end of study
- changes of six minutes walking distance [ Time Frame: 6 months ]measured by six minutes walking test at baseline, 3 months and the end of study
- change of health-related quality of life [ Time Frame: 6 months ]measure by St George Respiratory Questionnaire at baseline, 3 months and the end of study
- changes of breathlessness score [ Time Frame: 6 months ]measured by Borg scale (0-10) at baseline, 3 months and the end of study
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 6 months ]Common Terminology Criteria for Adverse Events (CTCAE) was used to collect adverse effects at baseline and through study completion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942926
|Contact: Kai-Feng Xufirstname.lastname@example.org|
|Principal Investigator:||Kai-Feng Xu, MD||Peking Union Medical College Hospital|