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OpenTrials
Completed

NCT Number: NCT03498742

Asthmatic Subjects Could Live Without Short Acting beta2 Agonists

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.

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Key information

Conditions

Asthma Chronic Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pulmonary Section

Granadero Baigorria, Santa Fe Province, 2152, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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. -

Exclusion criteria

Any other pulmonary disorder than asthma. Illiteracy.

-

Treatment and study plan

No intervention

Other

Routine clinical data; asthma control test and spirometry

Other names: Self-administered asthma control test and spirometry.

Primary outcomes

  1. Asthma Control Test

    Time frame: One year

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

Secondary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Rosario

Other

Registry information

Official study title

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

Acronym: NOSABA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 17, 2018
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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