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

NCT ID: NCT01741805

Last Updated: 2016-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-04-30

Brief Summary

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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

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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

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Severe Asthma

Patients with severe asthma as specified under inclusion, exclusion criteria

Severe Asthma

Intervention Type OTHER

Demographic data, Spirometry, induced sputum, IgE, Aspergillus specific IgE

Interventions

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Severe Asthma

Demographic data, Spirometry, induced sputum, IgE, Aspergillus specific IgE

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carmel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michal Shteinberg, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Pulmonology Institute, Carmel Medical Center

Locations

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Pulmonology Institute, Carmel Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CMC-12-0032-CTIL

Identifier Type: -

Identifier Source: org_study_id

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