AsthmaNCT01323010
Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes
A study testing Albuterol - Experimental in people with Asthma and Children, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Metered dose inhalers with spacers are devices capable of providing higher rates of lung deposition of drugs such as beta agonists when compared to conventional nebulizers, but there is no consensus about the optimal dose when this is the device of choice and there is evidence that younger children need proportionally… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- What is being tested?
- Albuterol - Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 2 to 18 years;
- History of two or more previous episodes of wheezing treated with bronchodilators in the last year;
- Wheezing attacks characterized by coughing, difficulty breathing and auscultation of expiratory wheezing or prolonged expiration;
- Intensity of wheezing attacks defined by PRAM score as moderate or severe (PRAM ≥ 5).
Who cannot join
- Pre-existing chronic diseases such as bronchopulmonary dysplasia, cystic fibrosis, bronchiolitis obliterans or other chronic pulmonary or cardiovascular disease;
- Initial clinical status indicating immediate ventilatory support, need for subcutaneous or intravenous bronchodilators;
- Decreased level of consciousness;
- Using a β-agonist in the four hours prior to arrival.
- Use of corticosteroids in the last 24h.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Increasing Doses of Inhaled Albuterol Administered by Metered Dose Inhalers in Children With Acute Wheezing Episodes
Metered dose inhalers with spacers are devices capable of providing higher rates of lung deposition of drugs such as beta agonists when compared to conventional nebulizers, but there is no consensus about the optimal dose when this is the device of choice and there is evidence that younger children need proportionally higher doses of albuterol (in μg/kg) when compared to older children. Other factors that may interfere with response to albuterol treatment include the genetics of the beta adrenergic receptor (ADRβ2) and infectious etiology of the wheezing attack. This study will assess the effectiveness of a dose regimen that prioritizes higher doses of albuterol, with doses in μg/kg higher for younger children. Security of this new dosing regimen will be assessed by monitoring clinical side effects and serum levels of albuterol, but the investigators will also examine the presence of 12 different respiratory viruses in these patients and evaluate the influence of ADRβ2 receptor genetics in the response to albuterol. The primary outcome measure will be the need for hospitalization. Secondary outcomes will include a change in clinical score, respiratory rate and forced expiratory volume in the first second, the need for additional treatments and length of stay in the emergency room for those not hospitalized.
Read the detailed description
This is a prospective, randomized, double blinded, controlled study. The patients will be randomly assigned to one of the treatment groups (experimental or control groups).
The patients will be assessed 1 hour later and every 30 minutes thereafter until discharge. Following 4 hours in the emergency room, any patient who do not meet the discharge criteria (PRAM score ≤ 3 and SpO2 ≥ 92%) will be admitted to the hospital. Each patient's attending physician will determine the need for additional therapies following the first hour.
Identification of respiratory viruses in the nasal lavage samples wil be performed using the CLART PneumoVir® kit.
Albuterol plasmatic levels will be analyzed via HPLC (High Performance Liquid Chromatography).
To genotype the ADBR2 receptor (blood samples), the gene regions encompassing the Arg16Gly, Gln27Glu, and Arg19Cys Thr164Ile polymorphisms will be amplified via PCR. The resultant amplimers were then sequenced.
A sample of 124 patients (62 in each group) was calculated to provide an 80% power with which to detect a significant difference of at least 30 minutes in the lengths of stay between the groups. The chi-square test will be used to compare hospital admission rates and tremor rates. For all other outcomes, t-tests for mean comparisons (variables with a normal distribution), a Mann Whitney test (nonparametric data) and ANOVA with repeated measures will be used.
- Being tested
- Albuterol - Experimental, Albuterol - Control
- Keywords
- asthma, albuterol, metered dose inhalers
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuterol - ExperimentalDrug
Also called Ventolin
The Experimental group will receive higher doses of albuterol in the first hour: 900 mcg (up to 15 kg), 1200 mcg (> 15 to 20 kg), 1500 mcg (> 20 to 25 kg) and 1800 mcg (> 25 kg).
Albuterol - ControlDrug
Also called Ventolin
The Control group will receive the following doses of albuterol in the first hour 600 mcg (up to 25 kg) or 1200 mcg (> 25 kg)
| Study group | Role | What they receive |
|---|---|---|
| Albuterol - Experimental | Experimental | Albuterol dosages during the first hour include 900 mcg (up to 15 kg), 1200 mcg (> 15 to 20 kg), 1500 mcg (> 20 to 25 kg) and 1800 mcg (> 25 kg). Receives: Drug: Albuterol - Experimental |
| Albuterol - Control | Active comparator | Albuterol dosages during the first hour include either 600 mcg (up to 25 kg) or 1200 mcg (> 25 kg). Receives: Drug: Albuterol - Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Admission
Hospital admission was defined as the need to stay in the emergency room for more than 4 hours, due to the failure to meet the discharge criteria (PRAM score ≤ 3 and pulse oximetry, ≥ 92%)
Measured: Starting at 4 hours post-treatment
Secondary outcomes (21)
Forced Expiratory Volume in the First Second
Change in FEV1 one hour post-treatment in comparison with baseline. Spirometry was performed only in subjects older than 6 years and who could perform the maneuver properly.
Measured: One hour post-treatment in comparison with baseline
Change in PRAM Score After One Hour
Change in the Pediatric Respiratory Assessment Measure (PRAM) score one hour post-treatment in comparison with baseline.
The PRAM score is used to assess the severity of asthma attacks, it ranges from 0 to 15, and the higher the score, the greater the severity of the attack.
We calculated the difference between the PRAM score measured one hour post treatment and the PRAM score at baseline (PRAM score 1 hour - PRAM score baseline).
The larger the absolute value of the difference, the better the outcome (e.g., a difference of -4 indicates a better outcome that a difference of -2).
minimum value of the difference (Albuterol - Higher Dose, experimental group): -8 maximum value of the difference (Albuterol - Higher Dose, experimental group): 0
minimum value of the difference (Albuterol - Lower Dose, control group): -8 maximum value of the difference (Albuterol - Lower Dose, control group): 0
Measured: One hour post-treatment
Albuterol Determination in the Plasma
Albuterol determination in the plasma was carried out at at discharge or hospital admission (up to 4 hours post treatment), dosage was accomplished by High Performance Liquid Chromatography.
Measured: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Changes in Glucose Serum Levels
Changes in glucose serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.
Measured: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
Electrocardiogram at Baseline
Electrocardiogram performed at baseline
Measured: at baseline
Changes in Respiratory Rate After One Hour
Change in respiratory rate one hour post-treatment in comparison with baseline.
Measured: One hour post-treatment in comparison with baseline
Need for Additional Therapies
The need for additional therapies such as magnesium sulphate or intravenous albuterol were recorded
Measured: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Changes in PRAM Score at Discharge or Hospital Admission
Change in the Pediatric Respiratory Assessment Measure (PRAM) score at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.
The PRAM score is used to assess the severity of asthma attacks, it ranges from 0 to 15, and the higher the score, the greater the severity of the attack.
We calculated the difference between the PRAM score measured at discharge or admission and the PRAM score at baseline (PRAM score discharge or admission - PRAM score baseline).
The larger the absolute value of the difference, the better the outcome (e.g., a difference of -4 indicates a better outcome that a difference of -2).
minimum value of the difference (Albuterol - Higher Dose, experimental group): -9 maximum value of the difference (Albuterol - Higher Dose, experimental group): 0
minimum value of the difference (Albuterol - Lower Dose, control group): -9 maximum value of the difference (Albuterol - Lower Dose, control group): 1
Measured: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
Changes in Potassium Serum Levels
Changes in potassium serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.
Measured: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
Changes in Bicarbonate Serum Levels
Changes in bicarbonate serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.
Measured: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
Changes in Respiratory Rate at at Discharge or Hospital Admission.
Changes in respiratory rate at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.
Measured: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
Change in Pulse Oximetry One Hour Post-treatment
Change in pulse oximetry one hour post-treatment in comparison with baseline
Measured: One hour post-treatment in comparison with baseline
Changes in Pulse Oximetry at Discharge or Hospital Admission.
Changes in pulse oximetry at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.
Measured: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
Changes in Heart Rate After One Hour
Change in heart rate one hour post-treatment in comparison with baseline.
Measured: One hour post-treatment in comparison with baseline
Changes in Heart Rate at Discharge or Hospital Admission
Changes in heart rate at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.
Measured: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Electrocardiogram One Hour Post-treatment.
Electrocardiogram one hour post-treatment to identify possible rhythm disturbances.
Measured: One hour post-treatment
Electrocardiogram at Discharge or Hospital Admission
Electrocardiogram at discharge or hospital admission to identify possible rhythm disturbances.
Measured: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Lengths of Stay in the Emergency Room
lengths of stay in the emergency room for discharged patients
Measured: one to four hours
Admission Rates in Patients With and Without Any Virus Detected
Admission rates in patients with and without any of the following viruses detected by PCR in nasal lavage samples: Adenovirus; Bocavirus; Coronavirus; Enterovirus (Echovirus); Influenza (A H3N2, A H1N1/2009, B and C); Metapneumovirus (subtypes A and B); Parainfluenza 1, 2, 3 and 4 (subtypes A and B); Rhinovirus; Respiratory Syncytial Virus type A and Respiratory Syncytial Virus type B.
Measured: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Admission Rates in Patients With and Without Rhinovirus Detect
Admission rates in patients with and without rhinovirus detected by PCR in nasal lavage samples.
Measured: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Admission Rates in Patients With the Arg16Gly Polymorphisms
Admission rates in patients with the Arg16Gly polymorphisms of the beta-2 adrenergic receptor (Arg16Gly, Arg16Arg and Gly16Gly genotypes).
Measured: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Luiz Vicente Ribeiro Ferreira da Silva Filho, University of Sao Paulo
- Investigators
- Luiz Vicente RF Silva Filho, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323010
- Sponsor's protocol ID
- Hidalba
- Status last verified
- Feb 2016
- First submitted
- 24 Mar 2011
- Last updated
- 14 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Muchao FP, Souza AV, Souza JME, Silva Filho LVRFD. Association between beta-2 adrenergic receptor variants and clinical outcomes in children and adolescents with acute asthma. Einstein (Sao Paulo). 2022 Mar 25;20:eAO6412. doi: 10.31744/einstein_journal/2022AO6412. eCollection 2022.
PubMed 35352766Muchao FP, Souza JM, Torres HC, De Lalibera IB, de Souza AV, Rodrigues JC, Schvartsman C, da Silva Filho LV. Albuterol via metered-dose inhaler in children: Lower doses are effective, and higher doses are safe. Pediatr Pulmonol. 2016 Nov;51(11):1122-1130. doi: 10.1002/ppul.23469. Epub 2016 May 12.
PubMed 27171324
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Increasing Doses of Inhaled Albuterol Administered by Metered Dose Inhalers in Children With Acute Wheezing Episodes
- ClinicalTrials.gov ID
- NCT01323010
- Acronym / sponsor ID
- Hidalba
- Keywords
- asthma, albuterol, metered dose inhalers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Sep 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Posted 14 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metered dose inhalers with spacers are devices capable of providing higher rates of lung deposition of drugs such as beta agonists when compared to conventional nebulizers, but there is no consensus about the optimal dose when this is the device of choice and there is evidence that younger children need proportionally higher doses of albuterol (in μg/kg) when compared to older children. Other factors that may interfere with response to albuterol treatment include the genetics of the beta adrenergic receptor (ADRβ2) and infectious etiology of the wheezing attack. This study will assess the effectiveness of a dose regimen that prioritizes higher doses of albuterol, with doses in μg/kg higher for younger children. Security of this new dosing regimen will be assessed by monitoring clinical side effects and serum levels of albuterol, but the investigators will also examine the presence of 12 different respiratory viruses in these patients and evaluate the influence of ADRβ2 receptor genetics in the response to albuterol. The primary outcome measure will be the need for hospitalization. Secondary outcomes will include a change in clinical score, respiratory rate and forced expiratory volume in the first second, the need for additional treatments and length of stay in the emergency room for those not hospitalized.
Detailed description
This is a prospective, randomized, double blinded, controlled study. The patients will be randomly assigned to one of the treatment groups (experimental or control groups).
The patients will be assessed 1 hour later and every 30 minutes thereafter until discharge. Following 4 hours in the emergency room, any patient who do not meet the discharge criteria (PRAM score ≤ 3 and SpO2 ≥ 92%) will be admitted to the hospital. Each patient's attending physician will determine the need for additional therapies following the first hour.
Identification of respiratory viruses in the nasal lavage samples wil be performed using the CLART PneumoVir® kit.
Albuterol plasmatic levels will be analyzed via HPLC (High Performance Liquid Chromatography).
To genotype the ADBR2 receptor (blood samples), the gene regions encompassing the Arg16Gly, Gln27Glu, and Arg19Cys Thr164Ile polymorphisms will be amplified via PCR. The resultant amplimers were then sequenced.
A sample of 124 patients (62 in each group) was calculated to provide an 80% power with which to detect a significant difference of at least 30 minutes in the lengths of stay between the groups. The chi-square test will be used to compare hospital admission rates and tremor rates. For all other outcomes, t-tests for mean comparisons (variables with a normal distribution), a Mann Whitney test (nonparametric data) and ANOVA with repeated measures will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albuterol - Experimental | Experimental | Drug: Albuterol - ExperimentalAlbuterol dosages during the first hour include 900 mcg (up to 15 kg), 1200 mcg (> 15 to 20 kg), 1500 mcg (> 20 to 25 kg) and 1800 mcg (> 25 kg). |
| Albuterol - Control | Active comparator | Drug: Albuterol - ControlAlbuterol dosages during the first hour include either 600 mcg (up to 25 kg) or 1200 mcg (> 25 kg). |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 2 to 18 years;
- History of two or more previous episodes of wheezing treated with bronchodilators in the last year;
- Wheezing attacks characterized by coughing, difficulty breathing and auscultation of expiratory wheezing or prolonged expiration;
- Intensity of wheezing attacks defined by PRAM score as moderate or severe (PRAM ≥ 5).
Key exclusion criteria (5 listed)
- Pre-existing chronic diseases such as bronchopulmonary dysplasia, cystic fibrosis, bronchiolitis obliterans or other chronic pulmonary or cardiovascular disease;
- Initial clinical status indicating immediate ventilatory support, need for subcutaneous or intravenous bronchodilators;
- Decreased level of consciousness;
- Using a β-agonist in the four hours prior to arrival.
- Use of corticosteroids in the last 24h.
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 |
|---|---|---|
| Albuterol - ExperimentalAlso: VentolinThe Experimental group will receive higher doses of albuterol in the first hour: 900 mcg (up to 15 kg), 1200 mcg (> 15 to 20 kg), 1500 mcg (> 20 to 25 kg) and 1800 mcg (> 25 kg). | Drug | Albuterol - Experimental |
| Albuterol - ControlAlso: VentolinThe Control group will receive the following doses of albuterol in the first hour 600 mcg (up to 25 kg) or 1200 mcg (> 25 kg) | Drug | Albuterol - Control |
Primary outcome
Hospital Admission
Time frame: Starting at 4 hours post-treatment
Hospital admission was defined as the need to stay in the emergency room for more than 4 hours, due to the failure to meet the discharge criteria (PRAM score ≤ 3 and pulse oximetry, ≥ 92%)
21 secondary outcomes
Forced Expiratory Volume in the First Second
Time frame: One hour post-treatment in comparison with baseline
Change in PRAM Score After One Hour
Time frame: One hour post-treatment
Albuterol Determination in the Plasma
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Changes in Glucose Serum Levels
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
Electrocardiogram at Baseline
Time frame: at baseline
Changes in Respiratory Rate After One Hour
Time frame: One hour post-treatment in comparison with baseline
Need for Additional Therapies
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Changes in PRAM Score at Discharge or Hospital Admission
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
Changes in Potassium Serum Levels
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
Changes in Bicarbonate Serum Levels
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
Changes in Respiratory Rate at at Discharge or Hospital Admission.
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
Change in Pulse Oximetry One Hour Post-treatment
Time frame: One hour post-treatment in comparison with baseline
Changes in Pulse Oximetry at Discharge or Hospital Admission.
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
Changes in Heart Rate After One Hour
Time frame: One hour post-treatment in comparison with baseline
Changes in Heart Rate at Discharge or Hospital Admission
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Electrocardiogram One Hour Post-treatment.
Time frame: One hour post-treatment
Electrocardiogram at Discharge or Hospital Admission
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Lengths of Stay in the Emergency Room
Time frame: one to four hours
Admission Rates in Patients With and Without Any Virus Detected
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Admission Rates in Patients With and Without Rhinovirus Detect
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Admission Rates in Patients With the Arg16Gly Polymorphisms
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35352766Muchao FP, Souza AV, Souza JME, Silva Filho LVRFD. Association between beta-2 adrenergic receptor variants and clinical outcomes in children and adolescents with acute asthma. Einstein (Sao Paulo). 2022 Mar 25;20:eAO6412. doi: 10.31744/einstein_journal/2022AO6412. eCollection 2022.
- Derived from this study: PubMed 27171324Muchao FP, Souza JM, Torres HC, De Lalibera IB, de Souza AV, Rodrigues JC, Schvartsman C, da Silva Filho LV. Albuterol via metered-dose inhaler in children: Lower doses are effective, and higher doses are safe. Pediatr Pulmonol. 2016 Nov;51(11):1122-1130. doi: 10.1002/ppul.23469. Epub 2016 May 12.
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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.
Luiz Vicente RF Silva Filho, MD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albuterol - Experimental in people with Asthma and Children, run by University of Sao Paulo 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 4 inclusion and 5 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 14 Mar 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hospital Admission (time frame: Starting at 4 hours post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01323010, which also lists 2 linked publications.
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 14 Mar 2016; AzTrials last refreshed its copy on 8 Nov 2026.