Asthmatic Subjects Could Live Without Short Acting beta2 Agonists

NCT03498742 | Completed

• 1 other identifier: HEEP-UNR-No SABA-02
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma Chronic

Keywords

asthma; SABA

Outcome Measures

Primary Outcomes (1)

• Asthma Control Test

  Score less than 16 indicates Poorly controlled asthma. Score \>19 indicates well controlled asthma.

  One year

Secondary Outcomes (1)

• Acute asthma attack requiring Hospitalization and/or Emergency Room visits in the last 12 months

  One year

Study Arms (2)

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

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

Interventions

NO Intervention OTHER

Routine clinical data; asthma control test and spirometry

Also known as: Self-administered asthma control test and spirometry.

No SABA users; SABA users

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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. -

You may not qualify if:

• Any other pulmonary disorder than asthma. Illiteracy.

Sponsors & Collaborators

• Universidad Nacional de Rosario: lead

Study Sites (1)

Pulmonary Section

Granadero Baigorria, Santa Fe Province, 2152, Argentina

Location

Related 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. No abstract available.

  PMID: 29241185 BACKGROUND

• 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.

  PMID: 18254477 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Luis J Nannini, MD

  Universidad Nacional de Rosario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonologist in Chief Pulmonary Section HEEP

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 17, 2018
• Study Start: March 10, 2017
• Primary Completion: January 16, 2018
• Study Completion: January 16, 2018
• Last Updated: April 17, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: From March 20 2018 until desired publication

Locations

AR (1)