Clinical Trial: Prospective Evaluation of Adult Pulmonary Langerhans Cell Histiocytosis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 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
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: 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


Original Primary Outcome: Pulmonary deterioration [ Time Frame: 2 years ]

decrease in FEV1, VC, or DLCO of at least 15% as compared to baseline values and/or progression of clinical symptoms (general symptoms) and/or occurrence of pneumothorax


Current Secondary Outcome:

  • Evolution of pulmonary volumes (FEV1) [ Time Frame: 6 months ]
  • Evolution of pulmonary lesions in High Resolution Computed Tomography (HRCT) [ Time Frame: 6 months ]


Original Secondary Outcome:

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: October 12, 2010
Date Started: May 2006
Date Completion:
Last Updated: April 15, 2016
Last Verified: March 2015