Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT01961258
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT01961258
Study Brief:
Protocol Section:
NCT01961258