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"SEVERE ASTHMA" in the COMMUNITY

NCT01961258 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2015-04-14

No results posted yet for this study

Summary

SEVERE ASTHMA IN THE COMMUNITY-

BACKGROUND Severe asthma is a common problem. In the world approximately 300 million people have asthma but it is estimated that only 5% of these patients have severe asthma. Although "severe asthma" comprises a small fraction of the entire asthmatic population its share in the total economic burden of asthma is 80 percent. In Israel the prevalence of asthma among adult patients is about 5-6% but the prevalence of severe asthma is unknown.

The definition of severe asthma has been changed during the years. Most recently in 2009 the WHO agreed on a unified definition of "severe asthma" that would fit countries of different socioeconomic development \[1\]. Severe asthma includes now 3 different groups: group one "untreated severe asthma", group two "difficult to treat severe asthma" and group three "treatment-resistant severe asthma". As all asthmatic patients in Israel have easy access to medical care, the current study will deal with the last two groups ("difficult to treat asthma" and "treatment resistant asthma").

AIMS Primary endpoints:

1. To identify the prevalence of severe asthma in the community according to the WHO definition of group two \& three.
2. To assess whether anti-IgE therapy (Omalizumab), was considered in these groups of severe asthma.

Secondary endpoints:

1. To assess factors involved in "difficult to treat asthma" according to the WHO definition. Factors as patient compliance, presence of co-morbidities, symptoms of untreated potential asthma triggers including GE reflux, post nasal drip/atopic rhino-sinusitis, and intervening medications including NSAID and beta-blockers.
2. To asses the level of asthma control, level of patient follow-up care including asthma specialist visits, periodic PFT's and asthma education.
3. To assess the fraction of patients with severe asthma that is eligible to anti-IgE therapy according to the indications of the Israeli Ministry of Health (proven asthma, uncontrolled by high dose of combined ICS+LABA inhaler therapy + at least 2 courses of systemic corticosteroids in the last year + proven atopy to at least one perennial aeroallergen + IgE level of 30-1,500 IU/ml)

DESIGN A prospective non-blinded non-randomized observation study among the population insured by Clalit Medical Services (CMS) in the Sharon- Shomron Medical District in Israel.

Conditions

Interventions

OTHER

Computerized data base analysis and sampling of patients for outpatient clinic evaluation

Sponsors & Collaborators

  • Meir Medical Center

    lead OTHER

Principal Investigators

  • Shabtai Varsano, M.D. · Head-Deputy Dept. of Pulmonary medicine. Head of Asthma Care and Education unit.

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-06-30
Completion
2016-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01961258 on ClinicalTrials.gov