The Clinical and Laboratory Phenotypes of Severe Asthma Patients in Clalit Health Services Haifa

Asthma Clinical Trial

Official title:

The Clinical and Laboratory Phenotypes of Severe Asthma Patients in Clalit Health Services Haifa.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01741805
• Other study ID #: CMC-12-0032-CTIL
• Status: Withdrawn
• Phase: N/A
• First received: December 2, 2012
• Last updated: July 28, 2016
• Start date: December 2012
• Est. completion date: April 2014

Study information

• Verified date: July 2016
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

Asthma is a chronic illness characterized by inflammation of the airways. Severe asthma is defined in the literature as asthma not controlled by medication. In recent years it has become known that severe asthma is a variable disease and has subtypes relating to the age of onset, type of inflammation and allergy, obesity, etc.

Our aim is to characterize the phenotypes of severe asthma population in our clinic and compare the prevalent phenotypes to the phenotypes described before.

Description:

Study measures will include the following:

• asthma demographic and symptoms questionnaire

• Validation of proper inhaler technique

• Height, weight measurements

• Forced spirometry and reversibility testing

• DLCO

• Fractional excretion of NO in exhaled breath

• Chest and sinus CT

• Induced sputum analysis

• Complete blood count, electrolytes, immunoglobulin E, Aspergillus Specific IgE

• Skin allergy testing

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Presence of Asthma- typical symptoms and signs accompanied by either: a. obstruction in Spirometry, OR- b. positive methacholine test

2. Regular use of high dose of inhaled corticosteroids (1000 micrograms of fluticasone per day or equivalent) in addition to a long acting beta agonist (LABA).

3. Lack of asthma control- 2 or more exacerbations in the past year- exacerbations defined by hospitalization or care in an emergency department or treatment with systemic glucocorticosteroids for exacerbation of asthma symptoms.

Exclusion Criteria:

1. Presence of another relevant respiratory illness, such as chronic obstructive pulmonary disease (COPD)

2. lack of adherence to medical therapy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Severe Asthma
Demographic data, Spirometry, induced sputum, IgE, Aspergillus specific IgE

Locations

Country	Name	City	State
Israel	Pulmonology Institute, Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume in 1 second (FEV1)		1 year	No
Secondary	Carbon Monoxide Diffusion Capacity (DLCO)		1 year	No
Secondary	Percent eosinophils in induced sputum sample		1 year	No
Secondary	Bronchiectasis on computerized tomography (CT)		1 year)	No
Secondary	Blood level of Total immunoglobulin E (IgE)		1 year	No
Secondary	Presence of blood antibody to Aspergillus Fumigatus		1 year	No
Secondary	Fraction of Nitric Oxide (NO) in expired air		1 year	No