Prospective Evaluation of Adult Pulmonary Langerhans Cell Histiocytosis

Adult Pulmonary Langerhans Cell Histiocytosis Clinical Trial

— LCHA1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225601
• Other study ID #: AOM 04141
• Status: Completed
• Phase: N/A
• First received: October 12, 2010
• Last updated: April 15, 2016
• Start date: May 2006
• Est. completion date: September 2010

Study information

• Verified date: March 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adult Pulmonary Langerhans Cell Histiocytosis
• Histiocytosis
• Histiocytosis, Langerhans-Cell

Intervention

Behavioral:
• Tabacco discontinuation
Tabacco discontinuation

Locations

Country	Name	City	State
France	Hôpital Saint Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Tazi A, de Margerie C, Naccache JM, Fry S, Dominique S, Jouneau S, Lorillon G, Bugnet E, Chiron R, Wallaert B, Valeyre D, Chevret S. The natural history of adult pulmonary Langerhans cell histiocytosis: a prospective multicentre study. Orphanet J Rare Dis — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years	No
Secondary	Evolution of pulmonary volumes (FEV1)		6 months	No
Secondary	Evolution of pulmonary lesions in High Resolution Computed Tomography (HRCT)		6 months	No