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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01741805
Enrollment
0
Registered
2012-12-05
Start date
2012-12-31
Completion date
2014-04-30
Last updated
2016-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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

Interventions

OTHERSevere Asthma

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

Sponsors

Carmel Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Forced Expiratory Volume in 1 second (FEV1)1 year

Secondary

MeasureTime frame
Percent eosinophils in induced sputum sample1 year
Bronchiectasis on computerized tomography (CT)1 year)
Carbon Monoxide Diffusion Capacity (DLCO)1 year
Presence of blood antibody to Aspergillus Fumigatus1 year
Fraction of Nitric Oxide (NO) in expired air1 year
Blood level of Total immunoglobulin E (IgE)1 year

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026