Prospective Evaluation of Adult Pulmonary Langerhans Cell Histiocytosis

Completed

• Conditions: Adult Pulmonary Langerhans Cell Histiocytosis
• Interventions: Behavioral: Tabacco discontinuation

• 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

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2009-05
• Study Completion: 2010-09
• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-20
• Study First Posted: 2010-10-21
• Status Verified: 2015-03
• Last Update Submitted: 2016-04-15
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Histocytosis	Tabacco discontinuation	Adult with isolated pulmonary Langerhans cell histiocytosis (pulmonary LCH)

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