Prospective Evaluation of Adult Pulmonary Langerhans Cell Histiocytosis
- Conditions
- Adult Pulmonary Langerhans Cell Histiocytosis
- Registration Number
- NCT01225601
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- Pulmonary Langerhans cell histiocytosis diagnosed within the past 48 months
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pulmonary deterioration 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 Outcome Measures
Name Time Method Evolution of pulmonary volumes (FEV1) 6 months Evolution of pulmonary lesions in High Resolution Computed Tomography (HRCT) 6 months
Trial Locations
- Locations (1)
Hôpital Saint Louis
🇫🇷Paris, France
Hôpital Saint Louis🇫🇷Paris, France