Clinical Trial: Assessment of Safety of Air Travel in Patients With Pulmonary Langerhans Cell Histiocytosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Assessment of Safety of Air Travel in Patients With Pulmonary Langerhans Cell Histiocytosis

Brief Summary: The aim of this study is to conduct survey-based assessments for the safety of air travel in patients with pulmonary Langerhans cell histiocytosis (PLCH). The study will enroll patients through the clinic network at Rare Lung Disease Consortium (RLDC) and through the Histiocytosis Association website. Patients will have access to the questionnaire via REDCap (an online data management system) and each patient will be provided with a link to complete the survey. The investigators plan on enrolling approximately 200 patients with PLCH for the purpose of this study. Secondary aims of this study include further characterization of the clinical aspects of disease and to establish a contact registry for these patients, in order to facilitate future studies.

Detailed Summary:

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


Sponsor: University of Cincinnati

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: University of Cincinnati

Dates:
Date Received: February 9, 2017
Date Started: June 2016
Date Completion: December 2018
Last Updated: February 13, 2017
Last Verified: February 2017