Trial Outcomes & Findings for Assessment of Safety of Air Travel in Patients With Birt-Hogg-Dube Syndrome (NCT NCT03040115)

NCT ID: NCT03040115

Last Updated: 2024-01-31

Results Overview

The investigators will measure the number of pneumothoraces that occur either during air travel, or within 24 hours of air travel among patients with Birt-Hogg-Dube syndrome. 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.

• Recruitment status: COMPLETED
• Target enrollment: 104 participants
• Primary outcome timeframe: During air travel or within 24 hours following air travel
• Results posted on: 2024-01-31

Participant Flow

Participant milestones

Measure	Patients Self-reporting With BHD Patients self-reporting with BHD
Overall Study STARTED	104
Overall Study COMPLETED	104
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Patients Self-reporting With BHD n=104 Participants Patients self-reporting with BHD
Age, Continuous	50 years n=104 Participants
Sex: Female, Male Female	86 Participants n=104 Participants
Sex: Female, Male Male	18 Participants n=104 Participants
Region of Enrollment United States	104 Participants n=104 Participants
Number of Participants with a History of Air Travel	99 participants n=104 Participants

PRIMARY outcome

Timeframe: 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 Birt-Hogg-Dube syndrome. 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.

Outcome measures

Measure	BHD Patients With Air Travel Related Pneumothorax n=104 Participants Air travel related pneumothorax in patients with BHD
Number of Patients With Birt-Hogg-Dube Syndrome Who Experienced Spontaneous Pneumothorax During or Within 24 Hours Following Air Travel	8 Participants

SECONDARY outcome

Timeframe: 3 years

The investigators will catalogue the number of spontaneous pneumothoraces experienced by patients with Birt-Hogg-Dube syndrome.

Outcome measures

Measure	BHD Patients With Air Travel Related Pneumothorax n=104 Participants Air travel related pneumothorax in patients with BHD
Number of Patients With Birt-Hogg-Dube Syndrome Who Experience a Spontaneous Pneumothorax	79 Participants

SECONDARY outcome

Timeframe: 3 years

The investigators will measure the incidence of ipsilateral pneumothorax following pleurodesis in order to determine the efficacy (as measured by the rate of pneumothorax recurrence following pleurodesis).

Outcome measures

Measure	BHD Patients With Air Travel Related Pneumothorax n=79 Participants Air travel related pneumothorax in patients with BHD
Number of Patients With Birt-Hogg-Dube Syndrome Who Experience Recurrent Pneumothorax Following Pleurodesis	29 Participants

Adverse Events

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth Kopras, Senior Research Associate

University of Cincinnati

Phone: 513-558-7205

Email: koprasej@uc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place