AsthmaPhase 4NCT03044938
Acute Effect of Salbutamol on Heart Rate and Blood Pressure During Exercise in Patients With Moderate or Severe Asthma and Healthy Subjects
A Phase 4 study testing salbutamol in people with Asthma and Heart Rate Fast, run by Universidade Ibirapuera at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Heart Rate Fast
- What is being tested?
- salbutamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Aug 2016to 21 Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- salbutamol, Placebo
- Keywords
- Asthma, Salbutamol, Exercise, Heart Rate, Blood pressure
- Medical subject headings
- Asthma, Tachycardia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salbutamolDrug
Also called Albuterol
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.
PlaceboDrug
Also called Falso
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: salbutamol |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 1 hour and after 1 week.
Secondary outcomes (3)
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.
Measured: Baseline and for 1 hour and after 1 week again.
Peak flow
Due to improved airflow brought by the drug, the peak expiratory flow is expected to increase with the use of salbutamol.
Measured: Baseline, 15 minutes final and after 1 week.
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.
Measured: 1 hour and after 1 week .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start6 Aug 2016
- Primary completion6 Aug 2016
- Study completion21 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized Clinical trial, controlled, double-blind and crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Ibirapuera
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo General Hospital
- Responsible party
- Principal investigator, Felipe Augusto Rodrigues Mendes, Universidade Ibirapuera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044938
- Sponsor's protocol ID
- 1.574.833
- Status last verified
- Feb 2017
- First submitted
- 23 Jan 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03044938
- Acronym / sponsor ID
- 1.574.833
- Conditions
- Asthma, Heart Rate Fast
- Keywords
- Asthma, Salbutamol, Exercise, Heart Rate, Blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universidade IbirapueraUniversity, hospital or other
- Collaborators
- University of Sao Paulo General Hospital
- Study start
- 6 Aug 2016 (actual)
- Primary completion
- 6 Aug 2016 (actual)
- Study completion
- 21 Nov 2016 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized Clinical trial, controlled, double-blind and crossover
| Arm | Type | Receives |
|---|---|---|
| Salbutamol | Experimental | Drug: salbutamolSalbutamol 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 | Drug: PlaceboInoculant 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. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- Individuals diagnosed with another lung disease,
- Have psychiatric, musculoskeletal or cardiovascular diseases,
- Being smokers
- Being pregnant
- Practice regular physical activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salbutamolAlso: AlbuterolSalbutamol 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. | Drug | Salbutamol |
| PlaceboAlso: FalsoNeutral 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. | Drug | Placebo |
Primary outcome
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.
3 secondary outcomes
Blood pressure
Time frame: Baseline and for 1 hour and after 1 week again.
Peak flow
Time frame: Baseline, 15 minutes final and after 1 week.
Subjective perception of Borg
Time frame: 1 hour and after 1 week .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing salbutamol in people with Asthma and Heart Rate Fast, run by Universidade Ibirapuera at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: Baseline up to 1 hour and after 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.