"SEVERE ASTHMA" in the COMMUNITY

NCT01961258 | Unknown

• 1 other identifier: 0016-13-MMC
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.To identify the prevalence of severe asthma in the community according to the WHO definition of group two \& three.
2. 2.To assess whether anti-IgE therapy (Omalizumab), was considered in these groups of severe asthma.
3. 3.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.
4. 4.To asses the level of asthma control, level of patient follow-up care including asthma specialist visits, periodic PFT's and asthma education.
5. 5.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)

Conditions

Severe Asthma

Keywords

Severe Asthma, Community, comorbidities, patient compliance,PFT, anti-IgE therapy

Outcome Measures

Primary Outcomes (2)

• The prevalence of severe asthma in the community according to the WHO definition of group two & three.

  To identify the prevalence of severe asthma in the community according to the WHO definition of group two \& three.

  1 year

• The prevalence of severe asthma in the community according to the WHO definition of group two & three.

  To assess whether anti-IgE therapy (Omalizumab), was considered in these groups of severe asthma.

  1 year

Secondary Outcomes (3)

• Factors involved in "difficult to treat asthma" according to the WHO definition.

  1 year

• Factors involved in "difficult to treat asthma" according to the WHO definition.

  1 year.

• Factors involved in "difficult to treat asthma" according to the WHO definition.

  1 year.

Study Arms (1)

Sever asthmatics in the comminity

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

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

Interventions

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

Sever asthmatics in the comminity

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include all patients at the age interval of 20-70 years with bronchial asthma treated by CMS, Sharon-Shomron district. 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, and January 1st -December 31, 2012. 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. B. 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". C. Patients with "severe asthma" that underwent evaluation for anti IgE-therapy.

You may qualify if:

• 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.
• Having computerized title-diagnosis of COPD, congestive heart failure, smoking, bronchiectasis, interstitial lung disease.
• Prescription of an oral or topical (ocular) beta-blockers.

You may not qualify if:

• Age \<20 or \>70 years old.

Sponsors & Collaborators

• Meir Medical Center: lead

Related Publications (2)

• Varsano S, Israeli L, Shitrit D. "Severe-controlled" asthma 4 years later: is it still controlled? J Asthma. 2021 Aug;58(8):1102-1110. doi: 10.1080/02770903.2020.1753208. Epub 2020 Apr 27.

  PMID: 32338094 DERIVED

• Varsano S, Segev D, Shitrit D. Severe and non-severe asthma in the community: A large electronic database analysis. Respir Med. 2017 Feb;123:131-139. doi: 10.1016/j.rmed.2016.12.017. Epub 2016 Dec 28.

  PMID: 28137489 DERIVED

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

• Shabtai Varsano, M.D.

  Head-Deputy Dept. of Pulmonary medicine. Head of Asthma Care and Education unit.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 11, 2013
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 14, 2015

Record last verified: 2013-10