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

NCT01741805 | Withdrawn

• 1 other identifier: CMC-12-0032-CTIL
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in 1 second (FEV1)

  1 year

Secondary Outcomes (6)

• 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

Study Arms (1)

Severe Asthma

Patients with severe asthma as specified under inclusion, exclusion criteria

Other: Severe Asthma

Interventions

Severe Asthma OTHER

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

Severe Asthma

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Presence of another relevant respiratory illness, such as chronic obstructive pulmonary disease (COPD)
• lack of adherence to medical therapy

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Pulmonology Institute, Carmel Medical Center

Haifa, 34632, Israel

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Michal Shteinberg, MD,PhD

  Pulmonology Institute, Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2012
• First Posted: December 5, 2012
• Study Start: December 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: April 1, 2014
• Last Updated: July 29, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)