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

NCT03044938 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-02-07

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    collaborator OTHER

  • Universidade Ibirapuera

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-06
Primary Completion
2016-08-06
Completion
2016-11-21

Countries

  • Brazil

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03044938 on ClinicalTrials.gov