Prospective Evaluation of Adult Pulmonary Langerhans Cell Histiocytosis

Assistance Publique - Hôpitaux de Paris62 enrolled

Overview

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 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 Type

OBSERVATIONAL

Enrollment

Conditions

Adult Pulmonary Langerhans Cell Histiocytosis

Interventions

Tabacco discontinuationBEHAVIORAL

Tabacco discontinuation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Saint Louis

Paris, Paris, France

Outcomes

Primary Outcomes

Pulmonary deterioration

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

Time frame: 2 years

Secondary Outcomes

Evolution of pulmonary volumes (FEV1)

Time frame: 6 months

Evolution of pulmonary lesions in High Resolution Computed Tomography (HRCT)

Time frame: 6 months

Data from ClinicalTrials.gov

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