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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741805
Recruitment Status : Withdrawn (Slow recruitment of patients)
First Posted : December 5, 2012
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Asthma Other: Severe Asthma

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

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Clinical and Laboratory Phenotypes of Severe Asthma Patients in Clalit Health Services Haifa.
Study Start Date : December 2012
Actual Primary Completion Date : November 2013
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
Severe Asthma
Patients with severe asthma as specified under inclusion, exclusion criteria
Other: Severe Asthma
Demographic data, Spirometry, induced sputum, IgE, Aspergillus specific IgE




Primary Outcome Measures :
  1. Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Carbon Monoxide Diffusion Capacity (DLCO) [ Time Frame: 1 year ]
  2. Percent eosinophils in induced sputum sample [ Time Frame: 1 year ]
  3. Bronchiectasis on computerized tomography (CT) [ Time Frame: 1 year) ]
  4. Blood level of Total immunoglobulin E (IgE) [ Time Frame: 1 year ]
  5. Presence of blood antibody to Aspergillus Fumigatus [ Time Frame: 1 year ]
  6. Fraction of Nitric Oxide (NO) in expired air [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741805


Locations
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Israel
Pulmonology Institute, Carmel Medical Center
Haifa, Israel, 34632
Sponsors and Collaborators
Carmel Medical Center
Investigators
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Principal Investigator: Michal Shteinberg, MD,PhD Pulmonology Institute, Carmel Medical Center
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Responsible Party: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01741805    
Other Study ID Numbers: CMC-12-0032-CTIL
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases