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

Withdrawn

• Conditions: Asthma
• Interventions: Other: Severe Asthma

• Registration Number: NCT01741805
• Lead Sponsor: Carmel Medical Center

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-02
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-05
• Primary Completion: 2013-11
• Study Completion: 2014-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe Asthma	Severe Asthma	Patients with severe asthma as specified under inclusion, exclusion criteria

Primary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in 1 second (FEV1)	1 year

Secondary Outcome Measures

Name	Time	Method
Carbon Monoxide Diffusion Capacity (DLCO)	1 year
Percent eosinophils in induced sputum sample	1 year
Bronchiectasis on computerized tomography (CT)	1 year)
Blood level of Total immunoglobulin E (IgE)	1 year
Presence of blood antibody to Aspergillus Fumigatus	1 year
Fraction of Nitric Oxide (NO) in expired air	1 year

Trial Locations

Locations (1)

Pulmonology Institute, Carmel Medical Center; 🇮🇱 Haifa, Israel