Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
042/2003
Study information
Scientific title
Effectiveness and safety of nebulized budesonide in controlling acute wheezing in under three-year-olds who are unresponsive to fenoterol
Acronym
Study hypothesis
This study aims to compare the efficacy and speed of response to treatment with nebulized budesonide and prednisone on acute wheezing in children under three years.
Ethics approval
Approved by the research ethics committee of the ABC School of Medicine on 5 July 2003 (ref: 042/2003)
Study design
Prospective, randomized, double-blind, placebo-controlled study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Wheezing in children
Intervention
Budesonide group (30 participants):
Nebulized Budesonide + Placebo (oral) + Fenoterol
Nebulized budesonide (Pulmicort®), 500 µg/dose four times on admission and on the first day. On the second and third day, 500 µg/dose three times per day. On the fourth and fifth day, 500 µg/dose twice per day. Finally, on the sixth and seventh day, 250 µg/dose twice per day. Also, this group took placebo (oral) at the same time and dose as the prednisone group. Nebulized fenoterol, 0.15 mg/kg/dose eight times per day on admission and on the first day. On the second and third day, 0.15mg/kg/dose six times per day. On the fourth and fifth day, 0.10 mg/kg/dose six times per day. Finally, on the sixth and seventh day, 0.10 mg/kg/dose four times per day.
Prednisone roup (30 participants):
Prednisone + Placebo (inhalation) + Fenoterol
Prednisone (Meticorten®), 2 mg/kg/dose once per day on admission, first, second and third day. On the fourth and fifth day, 1.5 mg/kg/dose once per day. Finally, on the sixth and seventh day, 1.0 mg/kg/dose once per day. Nebulized placebo was taken at the same dose and time as the budesonide group. Fenoterol was taken at the same dose and time as written above for the budesonide group.
Control group (15 participants):
Placebo inhalation + Placebo oral + Fenoterol
Placebo inhalation administered at the same time and dose as the budesonide group. Placebo (oral) administered at the same time and dose as the prednisone group and fenoterol was taken at the same dose and time as both budesonide and prednisone groups.
If the clinical situation deteriorated and reached Clinical score >5, two inhalations of fenoterol were given (0.15 mg/Kg/dose, interval 20 min). If the Clinical score did not change, randomization was interrupted and 500 µg of known budesonide was given. If in the following hour the Clinical score reduced and transcutaneous oxygen saturation (TSaO2) >91%, budesonide was maintained at the doses, timepoints and techniques defined in the study protocol. However, if Clinical score >= 7, TSaO2 <90%, arterial oxygen pressure less than 60 mmHg and carbon dioxide >50 mmHg, the study was stopped and considered a failure. Such cases on budesonide were called therapy failure.
Intervention type
Drug
Phase
Not Specified
Drug names
Nebulized budesonide and prednisone
Primary outcome measures
The following were assessed at admission, 20, 40, 60 and 90 min, 2, 4, 6, 12 and 24 hours, in the morning, afternoon, and evening on the first day after discharge from hospital, and then on the 10th and 15th day after discharge:
1. Wood Clinical Score
2. Pulse oximetry (TSaO2)
3. Respiratory frequency
4. Cough intensity
5. Dyspnea
6. Use of emergency bronchodilatory medication
Secondary outcome measures
Intensity of stress presented during the treatment, measured by the number of Wood Clinical Score obtained divided per the total patients number.
Overall trial start date
30/03/2003
Overall trial end date
30/10/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children from 1 month to 3 years old
2. Moderate to very severe acute wheezing, defined by a modified Wood clinical score over 3 after three doses of fenoterol at 20 minute intervals
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
75
Participant exclusion criteria
1. Previous use of systemic corticosteroid
2. Inhalation of corticosteroid or topical corticosteroid in the past 10 days
3. Cardiopathy
4. Nephropathy
5. Neuropathy
6. Inadequate nutritional level
Recruitment start date
30/03/2003
Recruitment end date
30/10/2006
Locations
Countries of recruitment
Brazil
Trial participating centre
Street Sosuke Shigekiyo, 68 Jardim Patente
Sao Paulo
04243-240
Brazil
Sponsor information
Organisation
The University of Medicine of Botucatu (UNESP) (Brazil)
Sponsor details
Pediatrics Department
District Rubiao Junior
Botucatu
Sao Paulo
18618-970
Brazil
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator-funded (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary