"SEVERE ASTHMA" in the COMMUNITY
"SEVERE ASTHMA" in the COMMUNITY
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.
SEVERE ASTHMA IN THE COMMUNITY- STUDY PROTOCOL-SYNOPSIS

 TITLE Severe Asthma in the Community: How severe it really is and to what extent its
 management has been exhausted PI Shabtai Varsano M.D. Head Asthma Clinic, Head-deputy Dept.
 of Pulmonary Medicine.

 Co-investigators Shitrit David M.D, Head Dept. of Pulmonary Medicine David Segev M.D Sharon
 -Shomron Medical District Headquarters, Clalit Medical Services.

 SITE Asthma Care & Education Unit, Dept of Pulmonary Medicine, Sapir Medical Center, Meir
 General Hospital Kfar-Sava, Israel.

 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.

 PROTOCOL:

 The study will include all patients at the age interval of 20-70 years with bronchial asthma
 treated by CMS, Sharon-Shomron district. The total population at this age interval that is
 insured by CMS in this district is 347,374.

 A. Screening of the computerized database of CMS to detect all patients at the age interval
 of 20-70 years with a computerized title-diagnosis of bronchial asthma during the period of
 January 1st -December 31, 2011. (preliminary data shows that the total asthmatic population
 at this age interval is 20,651 patients (5.94% of the entire population).

 B. To detect from this database the asthmatic patients that are considered to have "severe
 asthma" according to the level of medication that is prescribed to them (adjusted on the
 basis of severe/refractory asthma definition by the ATS workshop consensus 2000) [2].

 C. To detect the fraction of patients having co-morbidities and/or potential triggers
 (computerized title-diagnosis) that may interfere with asthma management (WHO group two:
 potentially "difficult to treat severe asthma"). Severe asthmatics without these
 co-morbidities /triggers will be considered as having WHO group three "treatment resistant
 severe asthma".

 D. To detect the fraction of the patients with "severe asthma" that underwent evaluation for
 anti IgE-therapy.

 E. To evaluate a sample of the above "severe asthma" population (WHO groups two and three) in
 the asthma outpatient clinic in Meir Hospital (estimated on the basis of preliminary data,
 200-250 patients). If the absolute number of patients in either WHO group two or group three
 will not exceed 150, all patients will be invited. If the number will exceed 150, then each
 second patient, consecutively according to the computerized list, will be invited.

 F. Patients invited to the asthma outpatient clinic will be evaluated by a pulmonary
 physician and complete a specific questionnaire regarding asthma control level (including
 non-scheduled use of medical resources), medication adherence, co-morbidities, smoking
 history, potential asthma triggers, level of asthma education, quality of follow-up care and
 potential adverse events in patients receiving anti-IgE therapy that are possibly related to
 this specific therapy.

 G. All patients will undergo post bronchodilator spirometric evaluation, assessment of blood
 cell counts for peripheral eosinophils, total IgE blood levels and skin testing for
 aeroallergens.

 H. Stages F and G of this protocol will be accomplished in one visit and there will be no
 more outpatint visits under this study.

 Inclusion criteria:

 A. Age 20-70 years old

 B. A computerized diagnosis-title of "bronchial asthma", at any stage of severity. A subgroup
 of the above asthmatic patients will be considered as having "severe asthma" according to the
 ATS workshop consensus definition of severe/refractory asthma, based on the level of
 prescribed medication criteria 2000:

 C. An obligatory criteria of at least 12 month inhaler-therapy prescription of a combination
 of high dose corticosteroid +LABA (at least 12 inhalers of Symbicort 160/4.5 mcg OR at least
 10 inhalers of Seretide 500 mcg, a year) PLUS at least one of the following criteria:

 D. Prescription of SABA, either Ventolin OR Bricalin inhalers at least once a quarter of a
 year or at least 4 inhalers in 12 months OR at least one prescription a month of
 inhalation-solution of Ventolin or Bricalin a month.

 E. Prescription of an oral or IM corticosteroid, at least twice in the last 12 months.

 The fulfilment of the above mentioned criteria indicates that these asthmatic patients are
 not conrolled, according to the GINA definition of controlled asthma.

 Asthmatics that potentially have "difficult to treat severe asthma" due to co-morbidities or
 potential triggering factors will be sub-grouped according to these criteria (criteria for
 potential exclusion of having "treatment resistant severe asthma"):

 A. Having computerized title-diagnosis of COPD, congestive heart failure, smoking,
 bronchiectasis, interstitial lung disease.

 B. Prescription of an oral or topical (ocular) beta-blockers.
Inclusion Criteria:

 -  Age 20-70 years old

 -  A computerized diagnosis-title of "bronchial asthma", at any stage of severity.

 A subgroup of the above asthmatic patients will be considered as having "severe asthma"
 according to the ATS workshop consensus definition of severe/refractory asthma, based on
 the level of prescribed medication criteria 2000:

 - An obligatory criteria of at least 12 month inhaler-therapy prescription of a combination
 of high dose corticosteroid +LABA (at least 12 inhalers of Symbicort 160/4.5 mcg OR at
 least 10 inhalers of Seretide 500 mcg, a year)

 PLUS at least one of the following criteria:

 -  Prescription of SABA, either Ventolin OR Bricalin inhalers at least once a quarter of
 a year or at least 4 inhalers in 12 months OR at least one prescription a month of
 inhalation-solution of Ventolin or Bricalin a month.

 -  Prescription of an oral or IM corticosteroid, at least twice in the last 12 months.

 The fulfilment of the above mentioned criteria indicates that these asthmatic patients are
 not conrolled, according to the GINA definition of controlled asthma.

 Asthmatics that potentially have "difficult to treat severe asthma" due to co-morbidities
 or potential triggering factors will be sub-grouped according to these criteria (criteria
 for potential exclusion of having "treatment resistant severe asthma"):

 -  Having computerized title-diagnosis of COPD, congestive heart failure, smoking,
 bronchiectasis, interstitial lung disease.

 -  Prescription of an oral or topical (ocular) beta-blockers.

 Exclusion Criteria:

 -  Age <20 or >70 years old.