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"SEVERE ASTHMA" in the COMMUNITY

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01961258
First Posted: October 11, 2013
Last Update Posted: April 14, 2015
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.
Information provided by (Responsible Party):
Meir Medical Center
  Purpose

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.


Condition Intervention
Severe Asthma Other: Computerized data base analysis and sampling of patients for outpatient clinic evaluation

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Target Follow-Up Duration: 30 Days
Official Title: "SEVERE ASTHMA" in the COMMUNITY: How Severe it Really is and to What Extent Its Management Has Been Exhausted

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • The prevalence of severe asthma in the community according to the WHO definition of group two & three. [ Time Frame: 1 year ]
    To identify the prevalence of severe asthma in the community according to the WHO definition of group two & three.

  • The prevalence of severe asthma in the community according to the WHO definition of group two & three. [ Time Frame: 1 year ]
    To assess whether anti-IgE therapy (Omalizumab), was considered in these groups of severe asthma.


Secondary Outcome Measures:
  • Factors involved in "difficult to treat asthma" according to the WHO definition. [ Time Frame: 1 year ]
    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.

  • Factors involved in "difficult to treat asthma" according to the WHO definition. [ Time Frame: 1 year. ]
    To assess the level of asthma control, level of patient follow-up care including asthma specialist visits, periodic PFT's and asthma education.

  • Factors involved in "difficult to treat asthma" according to the WHO definition. [ Time Frame: 1 year. ]
    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)


Estimated Enrollment: 250
Study Start Date: June 2015
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
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): NCT01961258


Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Shabtai Varsano, M.D. Head-Deputy Dept. of Pulmonary medicine. Head of Asthma Care and Education unit.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01961258     History of Changes
Other Study ID Numbers: 0016-13-MMC
First Submitted: October 7, 2013
First Posted: October 11, 2013
Last Update Posted: April 14, 2015
Last Verified: October 2013

Keywords provided by Meir Medical Center:
Severe Asthma, Community, comorbidities, patient compliance,PFT, anti-IgE therapy

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases