NCT01741805WithdrawnNot Applicable
The Clinical and Laboratory Phenotypes of Severe Asthma Patients in Clalit Health Services Haifa.
Carmel Medical Center1 site in 1 countryStarted: December 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Forced Expiratory Volume in 1 second (FEV1)
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Presence of Asthma- typical symptoms and signs accompanied by either: a. obstruction in Spirometry, OR- b. positive methacholine test
- •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).
- •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
- •Presence of another relevant respiratory illness, such as chronic obstructive pulmonary disease (COPD)
- •lack of adherence to medical therapy
Outcomes
Primary Outcomes
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: 1 year
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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