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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03498742
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
HEEP UNR, Universidad Nacional de Rosario

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.


Condition or disease Intervention/treatment
Asthma Chronic 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.

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Study Type : Observational
Actual Enrollment : 86 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Asthmatic Subjects Could Live Without Short Acting Beta2 Agonists (SABA)
Actual Study Start Date : March 10, 2017
Actual Primary Completion Date : January 16, 2018
Actual Study Completion Date : January 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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 Name: 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 Name: Self-administered asthma control test and spirometry.




Primary Outcome Measures :
  1. Asthma Control Test [ Time Frame: One year ]
    Score less than 16 indicates Poorly controlled asthma. Score >19 indicates well controlled asthma.


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498742


Locations
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Argentina
Pulmonary Section
Granadero Baigorria, Santa Fe, Argentina, 2152
Sponsors and Collaborators
Universidad Nacional de Rosario
Investigators
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Principal Investigator: Luis J Nannini, MD Universidad Nacional de Rosario

Publications:
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Responsible Party: HEEP UNR, Pulmonologist in Chief Pulmonary Section HEEP, Universidad Nacional de Rosario
ClinicalTrials.gov Identifier: NCT03498742    
Other Study ID Numbers: HEEP-UNR-No SABA-02
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Corresponding author (Luis J Nannini) shared all the available data of this observational not interventional study with the other 3 investigators.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: From March 20 2018 until desired publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HEEP UNR, Universidad Nacional de Rosario:
asthma
SABA
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases