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Completed

NCT Number: NCT01225601

Prospective Evaluation of Adult Pulmonary Langerhans Cell Histiocytosis

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

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Key information

Conditions

Adult Pulmonary Langerhans Cell Histiocytosis Hemic and Lymphatic Diseases Histiocytosis Histiocytosis, Langerhans-Cell Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint Louis

Paris, 75010, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tabacco discontinuation

Behavioral

Tabacco discontinuation

Primary outcomes

  1. 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

  1. Evolution of pulmonary volumes (FEV1)

    Time frame: 6 months

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: LCHA1

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Oct 21, 2010
Registry last updated
Apr 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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