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NCT Number: NCT03052101

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

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.

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Key information

Conditions

Pulmonary Langerhans Cell Histiocytosis Hemic and Lymphatic Diseases Histiocytosis Histiocytosis, Langerhans-Cell Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Pleural Diseases Pneumothorax Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267-0564, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Inability, or refusal, to sign informed consent.

Treatment and study plan

Primary outcomes

  1. Number of Participants With PLCH Who Experienced Spontaneous Pneumothorax During or Within 24 Hours Following Air Travel

    Time frame: During air travel or within 24 hours following air travel

    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 outcomes

  1. Number of Patients With Pulmonary Langerhans Cell Histiocytosis Who Experienced a Spontaneous Pneumothorax

    Time frame: 2 years and 6 months

    The investigators will catalogue the number of spontaneous pneumothoraces experienced by patients with pulmonary Langerhans cell histiocytosis.

  2. Number of Patients With Pulmonary Langerhans Cell Histiocytosis Who Experienced Recurrent Pneumothorax

    Time frame: 2 years and 6 months

    The investigators will measure the number of participants who experience a recurrent spontaneous pneumothorax.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

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

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 14, 2017
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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