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

NCT ID: NCT03044938

Last Updated: 2017-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-06
• Study Completion Date: 2016-11-21

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.

Conditions

Asthma; Heart Rate Fast

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

salbutamol

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Albuterol; Falso

Eligibility Criteria

Inclusion Criteria

• 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

• 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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: collaborator

Universidade Ibirapuera

OTHER

Sponsor Role: lead

Responsible Party

Felipe Augusto Rodrigues Mendes

Full Professor of Physiotherapy at the Ibirapuera University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jaqueline Ribas de Melo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

1.574.833

Identifier Type: -

Identifier Source: org_study_id