Duplication in CHIT1 Gene and the Risk for Aspergillus Lung Disease in CF Patients

Cystic Fibrosis Clinical Trial

Official title:

Duplication in CHIT1 Gene and the Risk for Aspergillus Lung Disease in CF Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572870
• Other study ID #: 450-10 CTIL
• Secondary ID: Chit 1
• Status: Completed
• Phase: N/A
• First received: April 4, 2012
• Last updated: June 27, 2016
• Start date: December 2010
• Est. completion date: September 2011

Study information

• Verified date: June 2016
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Title: Duplication in Chitotriosidase (CHIT1) Gene and the Risk for Aspergillus Lung Disease in CF Patients.

Aim: To evaluate the link between CHIT1 duplication in CF patients and the predisposition to ABPA or persistent Aspergillus infection.

Patients: 40 CF patients. Design: Observational, single visit. Methods: All patients will be assessed for pulmonary function tests (PFT), sputum cultures, and blood tests for: CHIT1 duplication, immunoglobulin E (IgE) and Eosinophils levels. Part of the patients will be assessed for RAST, skin prick test.

Primary outcome measure is the difference in CHIT1 genotyping between the groups.

Description:

Title: Duplication in Chitotriosidase (CHIT1) Gene and the Risk for Aspergillus Lung Disease in CF Patients.

Introduction: Chitinases are the enzymes that digest the chitin polymer. Plants use CHIT1 as an important innate defense mechanism against fungi. CHIT1 is the major chitinase in the human airways.Variation in the coding region, with 24-bp duplication allele results in a reduced CHIT1 activity. Recently, CHIT1 duplication was found in 6/6 patients with severe asthma and fungal sensitization Aspergillus often persists in the respiratory tract of patients with Cystic Fibrosis (CF) and may cause allergic broncho pulmonary aspergillosis (ABPA).

Aim: to evaluate the link between CHIT1 duplication in CF patients and the predisposition to ABPA or persistent Aspergillus infection.

Patients: 40 CF patients divided to three groups .Group 1: patients who have neither ABPA nor Aspergillus infection in the past (the control group).Group 2: patients with persistent Aspergillus infection, without ABPA. Group 3: patients with current or past ABPA.

Design: Observational, single visit. Methods: All patients will be assessed for pulmonary function tests (PFT), sputum cultures, and blood tests for: CHIT1 duplication, IgE and Eosinophils levels.

Patient's characteristics including demographics, CF mutations, pancreatic status and sweat test will be derived from the charts.

Patients with ABPA as well as Aspergillus infection had also radioallergosorbent test (RAST) for molds, as well as skin prick test for Aspergillus and blood Galactomannan.

The primary outcome measure is the difference in CHIT1 genotyping between the groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 50 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of Cystic Fibrosis.

Exclusion Criteria:

• Inability to produce sputum, or previous history of lung transplantation.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chit1
• Cystic Fibrosis
• Lung Diseases

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CHIT1 genotyping	In peripheral blood.	Baseline	No
Secondary	IgE	peripheral blood count	Baseline	No
Secondary	Eosinophils	peripheral blood count	Baseline	No
Secondary	skin test for aspergillus	skin prick test	Baseline	No
Secondary	galactomannan	peripheral blood count	Baseline	No
Secondary	pulmonary function test	spirometry	Baseline	No
Secondary	RAST test	Radioallergosorbent test (RAST) for molds	Baseline	No