Title

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

    Phase 4
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    albuterol ...
  • Study Participants

    15
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.
Study Started
Aug 06
2016
Primary Completion
Aug 06
2016
Study Completion
Nov 21
2016
Last Update
Feb 07
2017
Estimate

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.

  • Other names: Albuterol

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.

  • Other names: Falso

Salbutamol Experimental

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.

Placebo Placebo Comparator

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.

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)
No Results Posted