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Completed

NCT Number: NCT03044938

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

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.

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Key information

Conditions

Asthma Arrhythmias, Cardiac Behavior Bronchial Diseases Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Heart Rate Fast Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Tachycardia

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jaqueline Ribas de Melo

São Paulo, 04852227, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Salbutamol

Drug

Salbutamol or albuterol is a short-acting β2 adrenergic receptor agonist used for the relief of bronchospasm in conditions such as asthma and chronic obstructive pulmonary disease.

Other names: Albuterol

Placebo

Drug

Neutral preparation for pharmacological effects, given in substitution of a medicine, for the purpose of provoking or controlling reactions, ger. Of a psychological nature, accompanying such a therapeutic procedure.

Other names: Falso

Primary outcomes

  1. Heart rate

    Time frame: Baseline up to 1 hour and after 1 week.

    It is being considered that the asthmatic heart rate will increase after the use of salbutamol and that the increase will remain during and after the exercise, in relation to the placebo intervention. To evaluate this variable, the Polar RS800cx heart rate monitor will be used, where the participant will have his heart beats monitored beat to beat until the end of the protocol.

Secondary outcomes

  1. Blood pressure

    Time frame: Baseline and for 1 hour and after 1 week again.

    It is being considered that the systemic arterial pressure (SBP) of the asthmatic will not have significant alteration after the use of salbutamol during and after the exercise. To evaluate this variable, a Solidor manual sphygmomanometer and a supermed stethoscope will be used. The SBP will be measured after 10 minutes of initial rest, 15 minutes after administration of the drug, every 3 minutes during the physical test and every 5 minutes for 20 minutes at rest.

  2. Peak flow

    Time frame: Baseline, 15 minutes final and after 1 week.

    Due to improved airflow brought by the drug, the peak expiratory flow is expected to increase with the use of salbutamol.

  3. Subjective perception of Borg

    Time frame: 1 hour and after 1 week .

    The modified borg subjective perception scale will be used, where the perception of effort will be reported by a scale ranging from 0 to 10. The scale will be applied during the stress test every 3 minutes and during the final rest phase.

Sponsors and collaborators

Lead sponsor

Universidade Ibirapuera

Other

Collaborators

  • University of Sao Paulo General Hospital

Registry information

Official study title

Acute Effect of Salbutamol on Heart Rate and Blood Pressure During Exercise in Patients With Moderate or Severe Asthma and Healthy Subjects: Randomized, Double-blind, and Crossover Study

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 7, 2017
Registry last updated
Feb 7, 2017

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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