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

NCT ID: NCT03052101

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 94 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-12-31

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 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

Conditions

Pulmonary Langerhans Cell Histiocytosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rare Diseases Clinical Research Network

NETWORK

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Nishant Gupta, MD, MS

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31563637 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://redcap.research.cchmc.org/surveys/?s=C7EY4WNPEY

Link to completing the online study questionnaire

Other Identifiers

U54HL127672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RLDC5714B

Identifier Type: -

Identifier Source: org_study_id