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

NCT03044938 | Completed Phase 4 DMC

• 1 other identifier: 1.574.833
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma; Heart Rate Fast

Keywords

Asthma; Salbutamol; Exercise; Heart Rate; Blood pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Blood pressure

  Baseline and for 1 hour and after 1 week again.

• Peak flow

  Baseline, 15 minutes final and after 1 week.

• Subjective perception of Borg

  1 hour and after 1 week .

Study Arms (2)

Salbutamol

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Albuterol

Salbutamol

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.

Also known as: Falso

Placebo

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Individuals diagnosed with another lung disease,
• Have psychiatric, musculoskeletal or cardiovascular diseases,
• Being smokers
• Being pregnant
• Practice regular physical activity.
• 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
• Pregnant women
• Smokers
• Psychic diseases
• Osteomuscular diseases
• Practitioners of regular exercise

Sponsors & Collaborators

• Universidade Ibirapuera: lead
• University of Sao Paulo General Hospital: collaborator

Study Sites (1)

Jaqueline Ribas de Melo

São Paulo, São Paulo, 04852227, Brazil

Location

MeSH Terms

Conditions

Asthma; Tachycardia; Motor Activity

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Physiotherapy at the Ibirapuera University

Model Details: Randomized Clinical trial, controlled, double-blind and crossover

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: February 7, 2017
• Study Start: August 6, 2016
• Primary Completion: August 6, 2016
• Study Completion: November 21, 2016
• Last Updated: February 7, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)