Asthmatic Subjects Could Live Without Short Acting beta2 Agonists (NOSABA)

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma Chronic
• Intervention / Treatment: Other: NO Intervention

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 Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Argentina
  • Santa Fe
    • Granadero Baigorria, Santa Fe, Argentina, 2152
      • Pulmonary Section

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Outpatients coming for a first visit to the Pulmonary Section, not only due to asthma; but also for presurgical assessment and/or Spirometry prescription.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No SABA users; 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; Routine clinical data; asthma control test and spirometry; Other Names: Self-administered asthma control test and spirometry.
SABA users; 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; Routine clinical data; asthma control test and spirometry; Other Names: Self-administered asthma control test and spirometry.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Nacional de Rosario
• Investigators: Principal Investigator: Luis J Nannini, MD, Universidad Nacional de Rosario

Publications and helpful links

General Publications

• 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. No abstract available.
• Rodrigo GJ, Arcos JP, Nannini LJ, Neffen H, Broin MG, Contrera M, Pineyro 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Actual): January 16, 2018
• Study Completion (Actual): January 16, 2018

Study Registration Dates

• First Submitted: April 2, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 12, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: asthma; SABA
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: HEEP-UNR-No SABA-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Corresponding author (Luis J Nannini) shared all the available data of this observational not interventional study with the other 3 investigators.
• IPD Sharing Time Frame: From March 20 2018 until desired publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No