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Efficacy and Safety of Increasing Doses of Inhaled Albuterol Administered by Metered Dose Inhalers in Children With Acute Wheezing Episodes

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Sao Paulo
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Luiz Vicente Ribeiro Ferreira da Silva Filho, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01323010
First received: March 24, 2011
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Asthma
Children
Drug: Albuterol - Experimental
Drug: Albuterol - Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Increasing Doses of Inhaled Albuterol Administered by Metered Dose Inhalers in Children With Acute Wheezing Episodes

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Hospital Admission [ Time Frame: superior to 4 hours ] [ Designated as safety issue: No ]
    Hospital admission will be defined by the need to stay in the Hospital for a period greater than 4 hours


Secondary Outcome Measures:
  • Forced expiratory volume in the first second [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Change in FEV1 (Forced expiratory volume in the first second) value after 1 hour of treatment

  • Change in PRAM score [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Change in the pediatric Respiratory Assessment Measure (PRAM) score after 1 hour of treatment and after that with 30 minutes intervals up to discharge or admission

  • Albuterol determination in the plasma [ Time Frame: admission and 1 hour ] [ Designated as safety issue: Yes ]
    Albuterol determination in the plasma will be carried out at admission and after the first hour of treatment; dosage will be accomplished by High Performance Liquid Chromatography

  • Dosage of glucose and potassium plasma levels [ Time Frame: admission and after 1 hour ] [ Designated as safety issue: Yes ]
    Dosage of glucose and potassium plasma levels at admission and after 1 hour of inclusion

  • Electrocardiogram [ Time Frame: admission and after 1 hour ] [ Designated as safety issue: Yes ]
    Electrocardiogram at admission and after 1 hour to identify possible rhythm disturbances

  • Respiratory frequency [ Time Frame: admission and 1 hour ] [ Designated as safety issue: No ]
    Respiratory frequency at admission and after 1 hour

  • Need for additional therapies [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    The need for additional therapies such as magnesium sulphate or intravenous albuterol will be recorded


Estimated Enrollment: 124
Study Start Date: September 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Group
Dosing will be individualized in four categories according to body weight
Drug: Albuterol - Experimental
The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg
Active Comparator: Control group
Dosing will be dived according to consensus recommendations in only two categories according to body weight
Drug: Albuterol - Control
The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323010

Contacts
Contact: Luiz Vicente RF Silva Filho, MD 55 11 81825220 vicres@terra.com.br
Contact: Fabio P Muchao, MD 55 11 83835563 fabiomuchao@gmail.com

Locations
Brazil
Instituto da Crianca HCFMUSP Recruiting
Sao Paulo, Brazil, 05403-010
Contact: Joaquim C Rodrigues, MD    55 11 30698500    jocarod@uol.com.br   
Principal Investigator: Luiz Vicente RF Silva Filho, MD         
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
  More Information

No publications provided

Responsible Party: Luiz Vicente Ribeiro Ferreira da Silva Filho, MD PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01323010     History of Changes
Other Study ID Numbers: Hidalba
Study First Received: March 24, 2011
Last Updated: January 15, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
asthma
albuterol
metered dose inhalers

Additional relevant MeSH terms:
Albuterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on November 23, 2014