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

NCT03052101 | Completed Results

• 2 other identifiers: RLDC5714BU54HL127672
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Langerhans Cell Histiocytosis

Keywords

PLCH; Air travel; pneumothorax; pleurodesis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With PLCH Who Experienced Spontaneous Pneumothorax During 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.

  During air travel or within 24 hours following air travel

Secondary Outcomes (2)

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

  2 years and 6 months

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

  2 years and 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Pulmonary Langerhans Cell Histiocytosis

You may qualify if:

• 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

You may not qualify if:

• Inability, or refusal, to sign informed consent.

Sponsors & Collaborators

• University of Cincinnati: lead
• Rare Diseases Clinical Research Network: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267-0564, United States

Location

Related Publications (1)

• Singla A, Kopras EJ, Gupta N. Spontaneous pneumothorax and air travel in Pulmonary Langerhans cell histiocytosis: A patient survey. Respir Investig. 2019 Nov;57(6):582-589. doi: 10.1016/j.resinv.2019.07.004. Epub 2019 Sep 26.

  PMID: 31563637 DERIVED

Related Links

• Link to completing the online study questionnaire

MeSH Terms

Conditions

Histiocytosis, Langerhans-Cell; Pneumothorax

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases; Pleural Diseases

Results Point of Contact

• Title: Elizabeth Kopras
• Organization: University of Cincinnati

koprasej@uc.edu

513-558-4831

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 14, 2017
• Study Start: June 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 31, 2024
• Results First Posted: January 31, 2024

Record last verified: 2024-01

Locations

US (1)