Acute Effect of Salbutamol on Heart Rate and Blood Pressure During Exercise in Patients With Moderate or Severe Asthma and Healthy Subjects

Last updated: February 2, 2017
Sponsor: Universidade Ibirapuera
Overall Status: Completed

Phase

4

Condition

Heart Defect

Asthma

Fast Heart Rate (Tachycardia)

Treatment

N/A

Clinical Study ID

NCT03044938
1.574.833
  • Ages 20-59
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Contextualization: Exercise is a common triggers of bronchospasm in patients with asthma and healthy subjects. To prevent these symptoms frequently they have to use Short-Acting Beta2-Agonists. However, the cardiovascular effects of salbutamol during and after exercise remain poorly known.

Objective: To evaluate the effect of salbutamol on heart rate and blood pressure during exercise in patients with moderate or severe asthma and healthy individuals.

Methods: A randomized, double-blind, crossover study will be conducted which 13 individuals with moderate or severe persistent asthma and 13 healthy individuals aged between 20 to 59 years.

Patients will perform a maximal effort test on 2 nonconsecutive days, with either 400mcg Salbutamol or 4 placebo puffs. The order of use of placebo or salbutamol will be drawn. During the protocol, heart rate, blood pressure, perception of exertion and peak expiratory flow will be monitored.

Eligibility Criteria

Inclusion

Inclusion Criteria for asthmatics:

  • Have the diagnosis of moderate or severe asthma according to the clinical criteria described in the literature

  • Be between 20 and 59 years of age

  • Being from the Asthma Assistance and Research Center (NAPA) of University of São Paulo Faculty of Medicine Clinics Hospital

  • Have treatment at the outpatient clinic for at least 3 months,

  • Have a stable clinical condition for at least 30 days

  • Make use of the optimized medicine daily

  • Read and signed the TCLE approved by the Ethics and Research Committee of the Ibirapuera University (UNIB) under opinion nº 1,574,833

Exclusion Criteria for asthmatics:

  • Individuals diagnosed with another lung disease,

  • Have psychiatric, musculoskeletal or cardiovascular diseases,

  • Being smokers

  • Being pregnant

  • Practice regular physical activity.

Criterion for inclusion of healthy individuals

  • Be between 20 and 59 years of age

  • Healthy individuals

  • Both genders

  • Age between 20 and 59 years

  • Read and signed the TCLE approved by the Ethics and Research Committee of the Ibirapuera University (UNIB) under opinion nº 1,574,833

Criteria for the exclusion of healthy individuals

  • Pregnant women

  • Smokers

  • Psychic diseases

  • Osteomuscular diseases

  • Practitioners of regular exercise

  • Physical Activity Readiness Questionnaire (PAR-Q)

Study Design

Total Participants: 15
Study Start date:
August 06, 2016
Estimated Completion Date:
November 21, 2016

Connect with a study center

  • Jaqueline Ribas de Melo

    Sao Paulo, São Paulo 04852227
    Brazil

    Site Not Available

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