N/A
N=94
Assessment of Safety of Air Travel in Patients With Pulmonary Langerhans Cell Histiocytosis
Pulmonary Langerhans Cell Histiocytosis
Bottom Line
View on ClinicalTrials.gov: NCT03052101 ↗Enrolled (actual)
94
Serious AEs
—
Results posted
Jan 2024
Primary outcome: Primary: Number of Participants With PLCH Who Experienced Spontaneous Pneumothorax During or Within 24 Hours Following Air Travel — 2 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Cincinnati
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With PLCH Who Experienced Spontaneous Pneumothorax During or Within 24 Hours Following Air Travel |
2 | — |
| SECONDARY Number of Patients With Pulmonary Langerhans Cell Histiocytosis Who Experienced a Spontaneous Pneumothorax |
22 | — |
| SECONDARY Number of Patients With Pulmonary Langerhans Cell Histiocytosis Who Experienced Recurrent Pneumothorax |
14 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03052101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.