N/A
N=104
Assessment of Safety of Air Travel in Patients With Birt-Hogg-Dube Syndrome
Birt-Hogg-Dube Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03040115 ↗Enrolled (actual)
104
Serious AEs
—
Results posted
Jan 2024
Primary outcome: Primary: Number of Patients With Birt-Hogg-Dube Syndrome Who Experienced Spontaneous Pneumothorax During or Within 24 Hours Following Air Travel — 8 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Non-Interventional Study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Cincinnati
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Birt-Hogg-Dube Syndrome Who Experienced Spontaneous Pneumothorax During or Within 24 Hours Following Air Travel |
8 | — |
| SECONDARY Number of Patients With Birt-Hogg-Dube Syndrome Who Experience a Spontaneous Pneumothorax |
79 | — |
| SECONDARY Number of Patients With Birt-Hogg-Dube Syndrome Who Experience Recurrent Pneumothorax Following Pleurodesis |
29 | — |
Summary
The aim of this study is to conduct survey-based assessments for the safety of air travel in patients with Birt-Hogg-Dube syndrome (BHD). The study will enroll patients through the clinic network at Rare Lung Disease Consortium (RLDC) and through the BHD foundation 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 100 patients with BHD 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
- Diagnosis of BHD confirmed by either a) the presence of fibrofolliculomas/trichodiscomas on skin biopsy, or b) the presence of pathogenic FLCN mutations.
Exclusion Criteria
- Inability to give informed consent
Data sourced from ClinicalTrials.gov (NCT03040115). 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.