Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes

NCT01323010 | Completed Results

• 1 other identifier: Hidalba
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Asthma; Children

Keywords

asthma; albuterol; metered dose inhalers

Outcome Measures

Primary Outcomes (1)

• 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%)

  Starting at 4 hours post-treatment

Secondary Outcomes (21)

• Forced Expiratory Volume in the First Second

  One hour post-treatment in comparison with baseline

• Change in PRAM Score After One Hour

  One hour post-treatment

• Albuterol Determination in the Plasma

  at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)

• Changes in Glucose Serum Levels

  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

  at baseline

Study Arms (2)

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).

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).

Drug: Albuterol - Control

Interventions

Albuterol - Experimental DRUG

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).

Also known as: Ventolin

Albuterol - Experimental

Albuterol - Control DRUG

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)

Also known as: Ventolin

Albuterol - Control

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Instituto da Crianca HCFMUSP

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (2)

• 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.

  PMID: 35352766 DERIVED

• Muchao 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.

  PMID: 27171324 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Limitations and Caveats

The inclusion of a larger number of patients in this study may have uncovered differences in the efficacy outcomes studied between the groups.

Results Point of Contact

• Title: Dr Fabio Pereira Muchão
• Organization: University of Sao Paulo

fabiomuchao@gmail.com

+5511 983835563

Study Officials

• Luiz Vicente RF Silva Filho, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 25, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2014
• Last Updated: March 14, 2016
• Results First Posted: March 14, 2016

Record last verified: 2016-02

Locations

BR (1)