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

Asthma research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: 1. Aged 2 to 18 years; 2. History of two or more previous episodes of wheezing treated with bronchodilators in the last year; 3. Wheezing attacks characterized by coughing, difficulty breathing and auscultation of expiratory wheezing or prolonged expiration; 4. Intensity of wheezing attacks defined by PRAM score as moderate or severe (PRAM ≥ 5). Exclusion Criteria: 1. Pre-existing chronic diseases such as bronchopulmonary dysplasia, cystic fibrosis, bronchiolitis obliterans or other chronic pulmonary or cardiovascular disease; 2. Initial clinical status indicating immediate ventilatory support, need for subcutaneous or intravenous bronchodilators; 3. Decreased level of consciousness; 4. Using a β-agonist in the four hours prior to arrival. 5. Use of corticosteroids in the last 24h.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Asthma

Children

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Albuterol - ExperimentalThe 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 - ControlThe 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 Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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 - ControlAlbuterol dosages during the first hour include either 600 mcg (up to 25 kg) or 1200 mcg (> 25 kg).

Study Status

Completed

Start Date: September 2011

Completed Date: April 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Hospital Admission

Secondary Outcome: Forced Expiratory Volume in the First Second

Study sponsors, principal investigator, and references

Principal Investigator: Luiz Vicente RF Silva Filho, MD

Lead Sponsor: University of Sao Paulo

Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo

More information:https://clinicaltrials.gov/show/NCT01323010

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