Asthmatic Subjects Could Live Without Short Acting beta2 Agonists

Asthma Chronic Clinical Trial

— NOSABA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498742
• Other study ID #: HEEP-UNR-No SABA-02
• Status: Completed
• First received: April 2, 2018
• Last updated: April 12, 2018
• Start date: March 10, 2017
• Est. completion date: January 16, 2018

Study information

• Verified date: April 2018
• Source: Universidad Nacional de Rosario
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 16, 2018
• Est. primary completion date: January 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma Chronic

Intervention

Other:
• NO Intervention
Routine clinical data; asthma control test and spirometry

Locations

Country	Name	City	State
Argentina	Pulmonary Section	Granadero Baigorria	Santa Fe

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional de Rosario

Country where clinical trial is conducted

Argentina, 

References & Publications (2)

Nannini LJ, Neumayer NS. Treatment Step 1 for Asthma Should Not Be Left Blank, and SABA-Only Might Not Be a Treatment Step 1 Option for Asthma. Respiration. 2018;95(3):212-214. doi: 10.1159/000484568. Epub 2017 Dec 14. — View Citation

Rodrigo GJ, Arcos JP, Nannini LJ, Neffen H, Broin MG, Contrera M, Piñeyro L. Reliability and factor analysis of the Spanish version of the asthma control test. Ann Allergy Asthma Immunol. 2008 Jan;100(1):17-22. doi: 10.1016/S1081-1206(10)60399-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Test	Score less than 16 indicates Poorly controlled asthma. Score >19 indicates well controlled asthma.	One year
Secondary	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