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

Asthma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044938
• Other study ID #: 1.574.833
• Status: Completed
• Phase: Phase 4
• First received: January 23, 2017
• Last updated: February 2, 2017
• Start date: August 6, 2016
• Est. completion date: November 21, 2016

Study information

• Verified date: February 2017
• Source: Universidade Ibirapuera
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 21, 2016
• Est. primary completion date: August 6, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 59 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthma
• Heart Rate Fast
• Tachycardia

Intervention

Drug:
• salbutamol
Salbutamol or albuterol is a short-acting ß2 adrenergic receptor agonist used for the relief of bronchospasm in conditions such as asthma and chronic obstructive pulmonary disease.
• 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.

Locations

Country	Name	City	State
Brazil	Jaqueline Ribas de Melo	Sao Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Ibirapuera	University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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 .