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 |
| Protocol serial number | 042/2003 |
| Sponsor | The University of Medicine of Botucatu (UNESP) (Brazil) |
| Funder | Investigator-funded (Brazil) |
- 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
Scientific
Street Sosuke Shigekiyo, 68 Jardim Patente
Sao Paulo
04243-240
Brazil
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, randomized, double-blind, placebo-controlled study. |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Nebulized budesonide and prednisone |
| Primary outcome measure(s) |
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: |
| Key secondary outcome measure(s) |
Intensity of stress presented during the treatment, measured by the number of Wood Clinical Score obtained divided per the total patients number. |
| Completion date | 30/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Month |
| Upper age limit | 3 Years |
| Sex | All |
| Target sample size at registration | 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
04243-240
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
