Asthmatic Subjects Could Live Without Short Acting beta2 Agonists

Study Overview
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Brief Summary
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Since 2006 there was a plateau in world wide mortality from asthma. Overreliance in Short Acting Beta2 Agonists (SABA) was associated with increased risk of death from asthma. Long acting beta agonists (LABA) alone was not permitted as treatment for asthma as it was determined by FDA by the black box. By contrast SABA does not have a black box, despite similar overuse alerts associated with increased risk of death from asthma. the investigators want to know if exist asthmatic subjects that do use another rescue medication; not SABA, and to compare their features, Asthma Control Test (ACT), and lung function in a outpatient facility. First consecutive visits at outpatient Pulmonary Section of asthmatic subjects were described. Asthma Control Test (ACT) that was routinely used to assess asthma and spirometry were performed.

Detailed Description
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During the period from March 10, 2017 to January 16, 2018 the investigators decided to describe the rescue medication in all new asthmatic subjects that came for a first visit to the outpatient pulmonary department. Patients aged ≥16 years were entered in the study with a a diagnosis of asthma, based on a history of episodic dyspnea and wheezing, and/or documented bronchodilator reversibility in forced expiratory volume in 1 s (FEV1) of 12% and 200 ml according to the National Institutes of Health criteria; to be non- or ex-smoker of less than 10 pack-yr, to be neither pregnant nor breast-feeding and to be capable of completing Asthma control test and spirometry. Consecutive patients visiting the outpatient pulmonary department were included in the description.

Official Title
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Asthmatic Subjects Could Live Without Short Acting Beta2 Agonists (SABA)

Conditions
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Asthma Chronic

Intervention / Treatment
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* Other: NO Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of asthma, based on a history of episodic dyspnea and wheezing, and/or documented bronchodilator reversibility in forced expiratory volume in 1 s (FEV1) of 12% and 200 ml according to the National Institutes of Health criteria; to be non- or ex-smoker of less than 10 pack-yr, to be neither pregnant nor breast-feeding to be capable of completing Asthma control test and spirometry. - Exclusion Criteria: Any other pulmonary disorder than asthma. Illiteracy. -

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No SABA users<br>Asthmatic subjects that did not use short acting beta2 agonists in the last 3 months and being using none agent or ICS, systemic corticosteroids of combined ICS/LABA as relief symptoms agent. | Other: NO Intervention<br>* Routine clinical data; asthma control test and spirometry<br>* Other names: Self-administered asthma control test and spirometry.;|
| SABA users<br>Most of the asthmatic subjects usually inhale SABA as rescue medication and many times SABA is the only one prescribed treatment for asthma. | Other: NO Intervention<br>* Routine clinical data; asthma control test and spirometry<br>* Other names: Self-administered asthma control test and spirometry.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Test | Score less than 16 indicates Poorly controlled asthma. Score >19 indicates well controlled asthma. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute asthma attack requiring Hospitalization and/or Emergency Room visits in the last 12 months | Stay for more than 24 hs in the Emergency and/or Hospitalization due to acute asthma exacerbations in the 12 months before the current visit | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, SABA