An observational study in Asthma Chronic, sponsored by Universidad Nacional de Rosario. Completed at 1 site in Argentina. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-04-17.
Sponsored by Universidad Nacional de Rosario · Observational
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.
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 86 is below the median of 158 across 1,250 observational studies indexed under Asthma.
Browse Asthma studies →Universidad Nacional de Rosario is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Outpatients coming for a first visit to the Pulmonary Section, not only due to asthma; but also for presurgical assessment and/or Spirometry prescription.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any other pulmonary disorder than asthma. Illiteracy.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Also known as: Self-administered asthma control test and spirometry.
Asthma Control Test
Score less than 16 indicates Poorly controlled asthma. Score \>19 indicates well controlled asthma.
Time frame: One year
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
Time frame: One year
Plan to share: Yes — Corresponding author (Luis J Nannini) shared all the available data of this observational not interventional study with the other 3 investigators.
Supporting information: Study protocol, Clinical study report
Time frame: From March 20 2018 until desired publication
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Universidad Nacional de Rosario