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Clinical Trials/NCT01225601
NCT01225601CompletedNot Applicable

Epidemiology of Adult Adult Pulmonary Langerhans Cell Histiocytosis - A Multicenter Cohort Study

Assistance Publique - Hôpitaux de Paris1 site in 1 country62 target enrollmentStarted: May 2006Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
62
Locations
1
Primary Endpoint
Pulmonary deterioration
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Study objectives:

  • To estimate the incidence of pulmonary deterioration in adult pulmonary Langerhans cell histiocytosis
  • To assess the impact of tobacco discontinuation
  • Study Design Multicentric prospective cohort study
  • Main endpoint: Pulmonary deterioration
  • Sample size : 40 patients

Detailed Description

Study objectives To estimate the incidence of pulmonary deterioration in adult pulmonary Langerhans cell histiocytosis To assess the impact of tobacco discontinuation Study Design Multicentric prospective cohort study Main endpoint: Pulmonary deterioration Sample size : 40 patients

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Pulmonary Langerhans cell histiocytosis diagnosed within the past 48 months

Exclusion Criteria

  • •Age < 18
  • •Deep pulmonary dysfunction (CPT< 60%, FEV1< 30%, DLCO< 30%, partial pressure of oxygen in arterial blood (PaO2)< 60mmHg)
  • •No informed consent or consent withdrawal

Outcomes

Primary Outcomes

Pulmonary deterioration

Time Frame: 2 years

decrease in Forced expiratory volume in 1 second (FEV1), vital capacity (VC), or Diffusing capacity of the lung for carbon monoxide (DLCO) of at least 15% as compared to baseline values and/or progression of clinical symptoms (general symptoms) and/or occurrence of pneumothorax

Secondary Outcomes

  • Evolution of pulmonary volumes (FEV1)(6 months)
  • Evolution of pulmonary lesions in High Resolution Computed Tomography (HRCT)(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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