Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 857 for:    ALBUTEROL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044938
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Collaborator:
University of Sao Paulo General Hospital
Information provided by (Responsible Party):
Felipe Augusto Rodrigues Mendes, Universidade Ibirapuera

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.


Condition or disease Intervention/treatment Phase
Asthma Heart Rate Fast Drug: salbutamol Drug: Placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized Clinical trial, controlled, double-blind and crossover
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : August 6, 2016
Actual Primary Completion Date : August 6, 2016
Actual Study Completion Date : November 21, 2016


Arm Intervention/treatment
Experimental: 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.
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 Name: Albuterol

Placebo Comparator: 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.
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 Name: Falso




Primary Outcome Measures :
  1. Heart rate [ Time Frame: Baseline up to 1 hour and after 1 week. ]
    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 :
  1. Blood pressure [ Time Frame: Baseline and for 1 hour and after 1 week again. ]
    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.

  2. Peak flow [ Time Frame: Baseline, 15 minutes final and after 1 week. ]
    Due to improved airflow brought by the drug, the peak expiratory flow is expected to increase with the use of salbutamol.

  3. Subjective perception of Borg [ Time Frame: 1 hour and after 1 week . ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044938


Locations
Layout table for location information
Brazil
Jaqueline Ribas de Melo
Sao Paulo, São Paulo, Brazil, 04852227
Sponsors and Collaborators
Universidade Ibirapuera
University of Sao Paulo General Hospital

Layout table for additonal information
Responsible Party: Felipe Augusto Rodrigues Mendes, Full Professor of Physiotherapy at the Ibirapuera University, Universidade Ibirapuera
ClinicalTrials.gov Identifier: NCT03044938     History of Changes
Other Study ID Numbers: 1.574.833
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Felipe Augusto Rodrigues Mendes, Universidade Ibirapuera:
Asthma
Salbutamol
Exercise
Heart Rate
Blood pressure
Additional relevant MeSH terms:
Layout table for MeSH terms
Albuterol
Asthma
Tachycardia
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action