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

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

salbutamol

Placebo

About this trial

This is an interventional prevention trial for Asthma focused on measuring Asthma, Salbutamol, Exercise, Heart Rate, Blood pressure

Eligibility Criteria

20 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Jaqueline Ribas de Melo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Salbutamol

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

Heart rate

It is being considered that the asthmatic heart rate will increase after the use of salbutamol and that the increase will remain during and after the exercise, in relation to the placebo intervention. To evaluate this variable, the Polar RS800cx heart rate monitor will be used, where the participant will have his heart beats monitored beat to beat until the end of the protocol.

Secondary Outcome Measures

Blood pressure

It is being considered that the systemic arterial pressure (SBP) of the asthmatic will not have significant alteration after the use of salbutamol during and after the exercise. To evaluate this variable, a Solidor manual sphygmomanometer and a supermed stethoscope will be used. The SBP will be measured after 10 minutes of initial rest, 15 minutes after administration of the drug, every 3 minutes during the physical test and every 5 minutes for 20 minutes at rest.

Peak flow

Due to improved airflow brought by the drug, the peak expiratory flow is expected to increase with the use of salbutamol.

Subjective perception of Borg

The modified borg subjective perception scale will be used, where the perception of effort will be reported by a scale ranging from 0 to 10. The scale will be applied during the stress test every 3 minutes and during the final rest phase.

Full Information

NCT ID

NCT03044938

First Posted

January 23, 2017

Last Updated

February 2, 2017

Sponsor

Universidade Ibirapuera

Collaborators

University of Sao Paulo General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03044938

Brief Title

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

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

August 6, 2016 (Actual)

Primary Completion Date

August 6, 2016 (Actual)

Study Completion Date

November 21, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Ibirapuera

Collaborators

University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, Heart Rate Fast

Keywords

Asthma, Salbutamol, Exercise, Heart Rate, Blood pressure

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Model Description

Randomized Clinical trial, controlled, double-blind and crossover

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Salbutamol

Arm Type

Experimental

Arm 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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

salbutamol

Other Intervention Name(s)

Albuterol

Intervention Description

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

Intervention Name(s)

Placebo

Other Intervention Name(s)

Falso

Intervention Description

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.

Primary Outcome Measure Information:

Title

Heart rate

Description

It is being considered that the asthmatic heart rate will increase after the use of salbutamol and that the increase will remain during and after the exercise, in relation to the placebo intervention. To evaluate this variable, the Polar RS800cx heart rate monitor will be used, where the participant will have his heart beats monitored beat to beat until the end of the protocol.

Time Frame

Baseline up to 1 hour and after 1 week.

Secondary Outcome Measure Information:

Title

Blood pressure

Description

It is being considered that the systemic arterial pressure (SBP) of the asthmatic will not have significant alteration after the use of salbutamol during and after the exercise. To evaluate this variable, a Solidor manual sphygmomanometer and a supermed stethoscope will be used. The SBP will be measured after 10 minutes of initial rest, 15 minutes after administration of the drug, every 3 minutes during the physical test and every 5 minutes for 20 minutes at rest.

Time Frame

Baseline and for 1 hour and after 1 week again.

Title

Peak flow

Description

Due to improved airflow brought by the drug, the peak expiratory flow is expected to increase with the use of salbutamol.

Time Frame

Baseline, 15 minutes final and after 1 week.

Title

Subjective perception of Borg

Description

The modified borg subjective perception scale will be used, where the perception of effort will be reported by a scale ranging from 0 to 10. The scale will be applied during the stress test every 3 minutes and during the final rest phase.

Time Frame

1 hour and after 1 week .

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

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)

Facility Information:

Facility Name

Jaqueline Ribas de Melo

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

04852227

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

No

Asthma, Heart Rate Fast

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial