Asthmatic Subjects Could Live Without Short Acting beta2 Agonists

NCT ID: NCT03498742

Last Updated: 2018-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-10

Study Completion Date

2018-01-16

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.

Conditions

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Asthma Chronic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

NO Intervention

Intervention Type OTHER

Routine clinical data; 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.

NO Intervention

Intervention Type OTHER

Routine clinical data; asthma control test and spirometry

Interventions

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NO Intervention

Routine clinical data; asthma control test and spirometry

Intervention Type OTHER

Other Intervention Names

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Self-administered asthma control test and spirometry.

Eligibility Criteria

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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.

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Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Nacional de Rosario

OTHER

Sponsor Role lead

Responsible Party

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HEEP UNR

Pulmonologist in Chief Pulmonary Section HEEP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luis J Nannini, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad Nacional de Rosario

Locations

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Pulmonary Section

Granadero Baigorria, Santa Fe Province, Argentina

Site Status

Countries

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Argentina

References

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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.

Reference Type BACKGROUND
PMID: 29241185 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18254477 (View on PubMed)

Other Identifiers

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HEEP-UNR-No SABA-02

Identifier Type: -

Identifier Source: org_study_id

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