Effectiveness and safety of nebulized budesonide in controlling acute wheezing in under three-year-olds who are unresponsive to fenoterol

ISRCTN	ISRCTN21515674
DOI	https://doi.org/10.1186/ISRCTN21515674
Secondary identifying numbers	042/2003

Submission date: 01/12/2007
Registration date: 14/01/2008
Last edited: 09/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Margarete Silva
Scientific

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

Study information

Study design	Prospective, randomized, double-blind, placebo-controlled study.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Effectiveness and safety of nebulized budesonide in controlling acute wheezing in under three-year-olds who are unresponsive to fenoterol
Study objectives	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(s)	Approved by the research ethics committee of the ABC School of Medicine on 5 July 2003 (ref: 042/2003)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Nebulized budesonide and prednisone
Primary outcome measure	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 study start date	30/03/2003
Completion date	30/10/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Month
Upper age limit	3 Years
Sex	Both
Target number of participants	75
Key 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
Key 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
Date of first enrolment	30/03/2003
Date of final enrolment	30/10/2006

Locations

Countries of recruitment

Brazil

Study participating centre

Street Sosuke Shigekiyo, 68 Jardim Patente

Sao Paulo
04243-240
Brazil

Sponsor information

The University of Medicine of Botucatu (UNESP) (Brazil)
University/education

Pediatrics Department
District Rubiao Junior
Botucatu
Sao Paulo
18618-970
Brazil

Website	http://www.unesp.br
"ROR"	https://ror.org/00987cb86

Funders

Funder type

Other

Investigator-funded (Brazil)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan