Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03052101
Recruitment Status : Unknown
Verified February 2017 by Nishant Gupta, University of Cincinnati.
Recruitment status was:  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

Tracking Information
First Submitted Date February 9, 2017
First Posted Date February 14, 2017
Last Update Posted Date February 14, 2017
Actual Study Start Date June 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 13, 2017)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 13, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Safety of Air Travel in Patients With Pulmonary Langerhans Cell Histiocytosis
Official Title Assessment of Safety of Air Travel in Patients With Pulmonary Langerhans Cell Histiocytosis
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with Pulmonary Langerhans Cell Histiocytosis
Condition Pulmonary Langerhans Cell Histiocytosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Singla A, Kopras EJ, Gupta N. Spontaneous pneumothorax and air travel in Pulmonary Langerhans cell histiocytosis: A patient survey. Respir Investig. 2019 Nov;57(6):582-589. doi: 10.1016/j.resinv.2019.07.004. Epub 2019 Sep 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 13, 2017)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03052101
Other Study ID Numbers RLDC5714B
U54HL127672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nishant Gupta, University of Cincinnati
Study Sponsor University of Cincinnati
Collaborators
  • Rare Diseases Clinical Research Network
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators Not Provided
PRS Account University of Cincinnati
Verification Date February 2017