Asthmatic Subjects Could Live Without Short Acting beta2 Agonists

Completed

• Conditions: Asthma Chronic
• Interventions: Other: NO Intervention

• Registration Number: NCT03498742
• Lead Sponsor: Universidad Nacional de Rosario

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-03-10
• Primary Completion: 2018-01-16
• Study Completion: 2018-01-16
• Status Verified: 2018-04
• Study First Submitted: 2018-04-02
• Study First Submitted QC: 2018-04-12
• Last Update Submitted: 2018-04-12
• Study First Posted: 2018-04-17
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

1. 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;
2. to be non- or ex-smoker of less than 10 pack-yr,
3. to be neither pregnant nor breast-feeding
4. to be capable of completing Asthma control test and spirometry. -

Exclusion Criteria

Any other pulmonary disorder than asthma. Illiteracy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SABA users	NO Intervention	Most of the asthmatic subjects usually inhale SABA as rescue medication and many times SABA is the only one prescribed treatment for asthma.
No SABA users	NO Intervention	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.

Primary Outcome Measures

Name	Time	Method
Asthma Control Test	One year	Score less than 16 indicates Poorly controlled asthma. Score \>19 indicates well controlled asthma.

Secondary Outcome Measures

Name	Time	Method
Acute asthma attack requiring Hospitalization and/or Emergency Room visits in the last 12 months	One year	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

Trial Locations

Locations (1)

Pulmonary Section; 🇦🇷 Granadero Baigorria, Santa Fe, Argentina