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

Phase 4

Completed

• Conditions: Asthma; Heart Rate Fast
• Interventions: Drug: Placebo; Drug: salbutamol

• Registration Number: NCT03044938
• Lead Sponsor: Universidade Ibirapuera

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-06
• Primary Completion: 2016-08-06
• Study Completion: 2016-11-21
• Study First Submitted: 2017-01-23
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-02
• Last Update Submitted: 2017-02-02
• Study First Posted: 2017-02-07
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Salbutamol	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.

Primary Outcome Measures

Name	Time	Method
Heart rate	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 Outcome Measures

Name	Time	Method
Peak flow	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.
Blood pressure	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.
Subjective perception of Borg	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.

Trial Locations

Locations (1)

Jaqueline Ribas de Melo; 🇧🇷 Sao Paulo, São Paulo, Brazil