Clinical trial NCT01741805: The Clinical and Laboratory Phenotypes of Severe Asthma Patients in Clalit Health Services Haifa
Official title: The Clinical and Laboratory Phenotypes of Severe Asthma Patients in Clalit Health Services Haifa.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Asthma
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population of petients with severe asthma, described by presence of symptoms despite adequate treatment as described in the following sections.

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

Eligibility criteria: 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

Primary outcomes:
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 1 year
Secondary outcomes:
measure: Carbon Monoxide Diffusion Capacity (DLCO)
timeFrame: 1 year
measure: Percent eosinophils in induced sputum sample
timeFrame: 1 year
measure: Bronchiectasis on computerized tomography (CT)
timeFrame: 1 year)
measure: Blood level of Total immunoglobulin E (IgE)
timeFrame: 1 year
measure: Presence of blood antibody to Aspergillus Fumigatus
timeFrame: 1 year
measure: Fraction of Nitric Oxide (NO) in expired air
timeFrame: 1 year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Pulmonology Institute, Carmel Medical Center
Study officials:
affiliation: Pulmonology Institute, Carmel Medical Center
name: Michal Shteinberg, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: