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NCT01632111 Clinical Trial

Pulmonary Involvement in Patients With Fabry Disease

Fabry Disease Clinical Trial

Official title:
Impact of the Treatment With Agalsidase Alpha on Lung Function and on Pulmonary Involvement in Patients With Fabry Disease. A Multicenter, Retrospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01632111
Other study ID # Fabry
Secondary ID
Status Completed
Phase N/A
First received June 28, 2012
Last updated May 26, 2014
Start date July 2012
Est. completion date May 2014

Study information
Verified date May 2014
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial Summary

The objective of this study is to investigate whether Agalsidase alpha, a drug commonly prescribed in patients with Fabry disease, is associated with improvement of the pulmonary involvement. According to the Global Initiative for Obstructive Lung Disease (GOLD), the surrogate markers for obstructive lung diseases are a decrease in both forced expiratory volume in one second (FEV1) and FEV1/FVC ratio, whereas FVC is the forced vital capacity. However, the measurement of these lung function parameters is indicated as yearly follow-up examinations with or without the treatment of Agalsidase alpha in patients with Fabry disease.

Description:

Pulmonary function tests und DLCO measurements are performed yearly in relation with yearly follow up examinations in the Department of Internal Medicine from the University Hospital of Zurich. We will retrospectively collect the results of the pulmonary functions test (spirometry).

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion criteria:

- All patients with established diagnosis of Fabry disease

Exclusion criteria:

- Missing informed consent

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• Lung function measurement
Spirometry

Locations
Country Name City State
Switzerland University Hospital Zurich, Division of Internal Medicine Zurich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lung function measurements Retrospective analysis of yearly measured lung function parameters to investigate on the lung function changes in patients with Fabry disease From first consultation until present No
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