drugset / Trial / NCT00497523
Efficacy and Safety of Nebulised Beclomethasone Dipropionate Plus as Needed Salbutamol vs as Needed Salbutamol or as Needed Salbutamol/Beclomethasone Fixed Combination in Young Children With Asthma Symptoms
RandomizedParallel-groupDouble-blindTreatment
Summary
To demonstrate a superior efficacy of BDP plus rescue salbutamol suspension for nebulisation, compared to placebo plus rescue salbutamol, in the relief of symptoms of asthma in young children with persistent symptoms of asthma.
Timeline
- Start
- 2006-03
- Primary completion
- —
- Completion
- 2007-01
Publications
- Results Papi A, Nicolini G, Baraldi E, Boner AL, Cutrera R, Rossi GA, Fabbri LM; BEclomethasone and Salbutamol Treatment (BEST) for Children Study Group. Regular vs prn nebulized treatment in wheeze preschool children. Allergy. 2009 Oct;64(10):1463-1471. doi: 10.1111/j.1398-9995.2009.02134.x.
- Results Papi A, Nicolini G, Boner AL, Baraldi E, Cutrera R, Fabbri LM, Rossi GA. Short term efficacy of nebulized beclomethasone in mild-to-moderate wheezing episodes in pre-school children. Ital J Pediatr. 2011 Aug 22;37:39. doi: 10.1186/1824-7288-37-39.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Salbutamol | Unknown | 1600 ug | Inhaled |
| Comparator | Salbutamol | Unknown | 2500 ug | Inhaled |
| Subject | beclomethasone dipropionate | Other / unclassified | 400 ug | Inhaled |
| Subject | beclomethasone dipropionate | Other / unclassified | 800 ug | Inhaled |