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Prospective Evaluation of Adult Pulmonary Langerhans Cell Histiocytosis (LCHA1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01225601
First received: October 12, 2010
Last updated: November 19, 2012
Last verified: November 2012
History of Changes
  Purpose

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

Condition Intervention
Adult Pulmonary Langerhans Cell Histiocytosis
 Behavioral: Tabacco discontinuation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology of Adult Adult Pulmonary Langerhans Cell Histiocytosis - A Multicenter Cohort Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Pulmonary deterioration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • Evolution of pulmonary volumes (FEV1) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Evolution of pulmonary lesions in High Resolution Computed Tomography (HRCT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: May 2006
Study Completion Date: September 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Histocytosis
Adult with isolated pulmonary Langerhans cell histiocytosis (pulmonary LCH)
 Behavioral: Tabacco discontinuation
Tabacco discontinuation
Other Name: Tabacco discontinuation

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult Pulmonary Langerhans cell histiocytosis

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225601

Locations
France
Hôpital Saint Louis
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Abdellatif TAZI, MD PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01225601     History of Changes
Other Study ID Numbers: AOM 04141
Study First Received: October 12, 2010
Last Updated: November 19, 2012
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Histiocytosis
Histiocytosis, Langerhans-Cell
Lymphatic Diseases
 Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013