Condition category
Respiratory
Date applied
01/12/2007
Date assigned
14/01/2008
Last edited
09/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Margarete Silva

ORCID ID

Contact details

Street Sosuke Shigekiyo
68 Jardim Patente
Sao Paulo
04243-240
Brazil

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

http://www.unesp.br

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

Publication citations

Additional files

Editorial Notes