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

Universidade Ibirapuera

Status and phase: Completed; Phase 4

Conditions: Asthma; Heart Rate Fast

Treatments: Drug: salbutamol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03044938

1.574.833

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 20 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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15 participants in 2 patient groups, including a placebo group

Salbutamol

Experimental group

Description:

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.

Treatment:

Drug: salbutamol

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo