N/A N=119 Randomized Quadruple-blind Treatment

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

Asthma · Children

Bottom Line

View on ClinicalTrials.gov: NCT01323010 ↗

Enrolled (actual)

119

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcome: Primary: Hospital Admission — 11; 8 participants — p=0.689

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Albuterol - Experimental (Drug); Albuterol - Control (Drug)
Age: Pediatric, Adult · 2+ yrs
Sex: All
Sponsor: University of Sao Paulo
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Hospital Admission	11; 8	0.689
SECONDARY Forced Expiratory Volume in the First Second	14.67; 11.3	0.591
SECONDARY Change in PRAM Score After One Hour	-3; -4	0.150
SECONDARY Albuterol Determination in the Plasma	2.57; 1.08	0.042 sig
SECONDARY Changes in Glucose Serum Levels	34.73; 22.90	0.108
SECONDARY Electrocardiogram at Baseline	0; 0	—
SECONDARY Changes in Respiratory Rate After One Hour	-2.08; -4.31	0.122
SECONDARY Need for Additional Therapies	0; 0	—
SECONDARY Changes in PRAM Score at Discharge or Hospital Admission	-4.5; -5	0.164
SECONDARY Changes in Potassium Serum Levels	-0.38; -0.59	0.165
SECONDARY Changes in Bicarbonate Serum Levels	-1.75; -1.44	0.436
SECONDARY Changes in Respiratory Rate at at Discharge or Hospital Admission.	-2.92; -5.76	0.046 sig
SECONDARY Change in Pulse Oximetry One Hour Post-treatment	1.54; 1.39	0.723
SECONDARY Changes in Pulse Oximetry at Discharge or Hospital Admission.	2.14; 1.59	0.235
SECONDARY Changes in Heart Rate After One Hour	1.75; -1.47	0.284
SECONDARY Changes in Heart Rate at Discharge or Hospital Admission	-0.263; -0.65	0.905
SECONDARY Electrocardiogram One Hour Post-treatment.	0; 0	—
SECONDARY Electrocardiogram at Discharge or Hospital Admission	0; 0	—
SECONDARY Lengths of Stay in the Emergency Room	1.50; 1.40	0.892
SECONDARY Admission Rates in Patients With and Without Any Virus Detected	12.3; 22.7	0.195
SECONDARY Admission Rates in Patients With and Without Rhinovirus Detect	10.2; 20.6	0.203
SECONDARY Admission Rates in Patients With the Arg16Gly Polymorphisms	1; 1; 7	0.03 sig

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.

Eligibility Criteria

Inclusion Criteria

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).

Exclusion Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT01323010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.