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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Heart Rate Fast
• Intervention / Treatment: Drug: salbutamol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Sao Paulo, São Paulo, Brazil, 04852227
      • Jaqueline Ribas de Melo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 59 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Salbutamol; Salbutamol is a bronchodilator that relaxes the muscles of the airways and increases the flow of air to the lungs. With the aid of a spacer, 400mcg of the drug will be administered once during the protocol.	Drug: salbutamol; 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_COMPARATOR: Placebo; Inoculant treatment through a substance that does not have an inherent power to produce an effect that is desired or expected. Four placebo puffs will be offered through a device similar to the salbutamol intervention device.	Drug: Placebo; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	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.	Baseline up to 1 hour and after 1 week.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	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.	Baseline and for 1 hour and after 1 week again.
Peak flow	Due to improved airflow brought by the drug, the peak expiratory flow is expected to increase with the use of salbutamol.	Baseline, 15 minutes final and after 1 week.
Subjective perception of Borg	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.	1 hour and after 1 week .

Collaborators and Investigators

• Sponsor: Universidade Ibirapuera
• Collaborators: University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 6, 2016
• Primary Completion (ACTUAL): August 6, 2016
• Study Completion (ACTUAL): November 21, 2016

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (ESTIMATE): February 7, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Exercise; Asthma; Blood pressure; Heart Rate; Salbutamol
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Arrhythmias, Cardiac; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Cardiac Conduction System Disease; Asthma; Tachycardia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: 1.574.833

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No