Clinical trial NCT03044938: Acute Effect of Salbutamol on Heart Rate and Blood Pressure During Exercise in Patients With Moderate or Severe Asthma and Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Heart Rate Fast
Keywords: Asthma
Salbutamol
Exercise
Heart Rate
Blood pressure
Lead sponsor: Universidade Ibirapuera
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo General Hospital
First posted: 2017-02-07
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized Clinical trial, controlled, double-blind and crossover
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Heart rate
timeFrame: Baseline up to 1 hour and after 1 week.
Secondary outcomes:
measure: Blood pressure
timeFrame: Baseline and for 1 hour and after 1 week again.
measure: Peak flow
timeFrame: Baseline, 15 minutes final and after 1 week.
measure: Subjective perception of Borg
timeFrame: 1 hour and after 1 week .
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Jaqueline Ribas de Melo
state: São Paulo
Study officials:
References: