Assessment of Safety of Air Travel in Patients With Pulmonary Langerhans Cell Histiocytosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03052101|
Recruitment Status : Unknown
Verified February 2017 by Nishant Gupta, University of Cincinnati.
Recruitment status was: Recruiting
First Posted : February 14, 2017
Last Update Posted : February 14, 2017
|Condition or disease|
|Pulmonary Langerhans Cell Histiocytosis|
The study will enroll participants through the clinic network at the Rare Lung Disease Consortium (RLDC) and through the Histiocytosis Association websites. Participants will have access to the questionnaire via REDCap (an online data management system) and each participant will be provided a link to complete the survey. In case of lack of internet access or inability to complete the online questionnaire, a paper survey will be mailed out with a pre-paid envelope to return the survey.
Primary Study Objective(s):
To define the risk of pneumothorax associated with air travel in patients with PLCH.
Secondary Study Objective(s):
To establish a contact registry for patients with PLCH to facilitate future trials To assess the rate of pneumothorax recurrence in patients with PLCH To assess the efficacy of pleurodesis in preventing recurrent pneumothoraces among patients with PLCH
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Assessment of Safety of Air Travel in Patients With Pulmonary Langerhans Cell Histiocytosis|
|Actual Study Start Date :||June 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
- Incidence of spontaneous pneumothorax during or within 24 hours following air travel [ Time Frame: 3 years ]The investigators will measure the number of pneumothoraces that occur either during air travel, or within 24 hours of air travel among patients with pulmonary Langerhans cell histiocytosis. The incidence of air travel related pneumothorax will be calculated by dividing the number of pneumothoraces to the total number of flights undertaken by the entire cohort.
- Rate of recurrent pneumothorax in patients with pulmonary Langerhans cell histiocytosis [ Time Frame: 3 years ]The investigators will catalogue the number of spontaneous pneumothoraces experienced by patients with pulmonary Langerhans cell histiocytosis. These results will be used to calculate the proportion of patients who experience at least one recurrence of their pneumothorax, as well as the average number of pneumothoraces experienced per patient.
- Efficacy of pleurodesis in reducing the risk of recurrent pneumothoraces in patients with pulmonary Langerhans cell histiocytosis. [ Time Frame: 3 years ]The investigators will measure the incidence of ipsilateral pneumothorax following pleurodesis in order to determine the efficacy (as measured by the rate of pneumothorax recurrence following pleurodesis). These results will be calculated separately for chemical and surgical pleurodesis.
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): NCT03052101
|Contact: Elizabeth J Kopras, BAfirstname.lastname@example.org|
|United States, Ohio|
|University of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45267-0564|
|Contact: Elizabeth J Kopras, BA 513-558-7205 email@example.com|