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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN21515674

Enrollment

Registered

2008-01-14

Start date

2003-03-30

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wheezing in children Respiratory Wheezing in children

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Intensity of stress presented during the treatment, measured by the number of Wood Clinical Score obtained divided per the total patients number.	—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026