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

Sponsor

University of Cincinnati (Other)

Overall Status

Unknown status

CT.gov ID

NCT03052101

Collaborator

Rare Diseases Clinical Research Network (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)

200

Enrollment

Location

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Langerhans Cell Histiocytosis

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jun 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Outcome Measures

Primary Outcome Measures

Incidence of spontaneous pneumothorax during or within 24 hours following air travel [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.

Secondary Outcome Measures

Rate of recurrent pneumothorax in patients with pulmonary Langerhans cell histiocytosis [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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult, age 18 or older
English literate
Signed, dated informed consent; either given electronically or via paper form
Confirmed diagnosis of PLCH based either on characteristic radiologic findings, or histopathological confirmation