Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Sao Paulo General Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| salbutamol | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to 1 hour and after 1 week. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria for asthmatics:
Exclusion Criteria for asthmatics:
Criterion for inclusion of healthy individuals
Criteria for the exclusion of healthy individuals
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaqueline Ribas de Melo | São Paulo | São Paulo | 04852227 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| D013610 | Tachycardia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Randomized Clinical trial, controlled, double-blind and crossover
Not provided
Not provided
Not provided
|
| Placebo | 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. |
|
|
| 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. | 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. | 1 hour and after 1 week . |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |