Trial Outcomes & Findings for Assessment of Safety of Air Travel in Patients With Pulmonary Langerhans Cell Histiocytosis (NCT NCT03052101)

NCT ID: NCT03052101

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 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.

• Recruitment status: COMPLETED
• Target enrollment: 94 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	Cohort Self-reported PLCH participants who completed an online survey.
Overall Study STARTED	94
Overall Study COMPLETED	94
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cohort n=94 Participants Self-reported PLCH participants who completed an online survey.
Age, Continuous	47 years n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	90 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	94 participants n=5 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 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.

Outcome measures

Measure	Cohort n=94 Participants Self-reported PLCH participants who completed an online survey.
Number of Participants With PLCH Who Experienced Spontaneous Pneumothorax During or Within 24 Hours Following Air Travel	2 Participants

SECONDARY outcome

Timeframe: 2 years and 6 months

The investigators will catalogue the number of spontaneous pneumothoraces experienced by patients with pulmonary Langerhans cell histiocytosis.

Outcome measures

Measure	Cohort n=94 Participants Self-reported PLCH participants who completed an online survey.
Number of Patients With Pulmonary Langerhans Cell Histiocytosis Who Experienced a Spontaneous Pneumothorax	22 Participants

SECONDARY outcome

Timeframe: 2 years and 6 months

The investigators will measure the number of participants who experience a recurrent spontaneous pneumothorax.

Outcome measures

Measure	Cohort n=22 Participants Self-reported PLCH participants who completed an online survey.
Number of Patients With Pulmonary Langerhans Cell Histiocytosis Who Experienced Recurrent Pneumothorax	14 Participants

Adverse Events

Cohort

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

University of Cincinnati

Phone: 513-558-4831

Email: koprasej@uc.edu

Results disclosure agreements

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