ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03052101
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : February 14, 2017
Sponsor:
Collaborators:
Rare Diseases Clinical Research Network
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Nishant Gupta, University of Cincinnati

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.

Condition or disease
Pulmonary Langerhans Cell Histiocytosis

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


Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assessment of Safety of Air Travel in Patients With Pulmonary Langerhans Cell Histiocytosis
Actual Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018





Primary Outcome Measures :
  1. Incidence of spontaneous pneumothorax during or within 24 hours following air travel [ Time Frame: 3 years ]
    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.


Secondary Outcome Measures :
  1. Rate of recurrent pneumothorax in patients with pulmonary Langerhans cell histiocytosis [ Time Frame: 3 years ]
    The investigators will catalogue the number of spontaneous pneumothoraces experienced by patients with pulmonary Langerhans cell histiocytosis. These results will be used to calculate the proportion of patients who experience at least one recurrence of their pneumothorax, as well as the average number of pneumothoraces experienced per patient.

  2. Efficacy of pleurodesis in reducing the risk of recurrent pneumothoraces in patients with pulmonary Langerhans cell histiocytosis. [ Time Frame: 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). These results will be calculated separately for chemical and surgical pleurodesis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with Pulmonary Langerhans Cell Histiocytosis
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052101


Contacts
Contact: Elizabeth J Kopras, BA 513-558-7205 koprasej@ucmail.uc.edu

Locations
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267-0564
Contact: Elizabeth J Kopras, BA    513-558-7205    koprasej@ucmail.uc.edu   
Sponsors and Collaborators
University of Cincinnati
Rare Diseases Clinical Research Network
National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
Responsible Party: Nishant Gupta, Assistant Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03052101     History of Changes
Other Study ID Numbers: RLDC5714B
U54HL127672 ( U.S. NIH Grant/Contract )
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017

Keywords provided by Nishant Gupta, University of Cincinnati:
PLCH
Air travel
pneumothorax
pleurodesis

Additional relevant MeSH terms:
Histiocytosis
Histiocytosis, Langerhans-Cell
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases