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

Study Identifier:
MC/PR/1404/002/05
ClinicalTrials.gov Identifier:
NCT00497523
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
See Study Publication Below
Study Complete

Study Details

Medical Condition
  • Asthma
Study Drug
  • Drug: Beclomethasone dipropionate
  • Drug: Beclomethasone dipropionate/Salbutamol combination
  • Drug: Salbutamol
Date
Mar 2006 - N/A
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 1 Year - 4 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Patients will be enrolled into the 2-week placebo run-in period if they meet all the following criteria:
  • Age ≥ 1 year and ≤ 4 years.
  • At least 3 episodes of wheeze or asthma-like symptoms in the 6 months preceding the study entry.
  • A cooperative attitude and ability to be trained to inhale correctly from the device and to complete the diary cards.
  • Written parental/guardian informed consent obtained.
  • Patients will be then randomised to the treatment period if they meet all the previous criteria plus:
  • Presence in at least 7 days out of the 14 days of the run-in period of at least one of the following symptoms: wheeze, cough or shortness of breath; or had required at least one dose of relief salbutamol.
Exclusion Criteria
  • History of severe asthma exacerbation or exacerbations requiring hospitalisation in the previous 4 weeks.
  • Symptomatic infection of the airways requiring treatment with antibiotics or antimycotics in the previous 4 weeks.
  • Treatment with inhaled steroids in the previous 4 weeks or oral steroids in the previous 8 weeks.
  • Treatment with methyl-xantine derivatives in the previous 4 weeks.
  • Treatment with long-acting β2-agonists in the previous 2 weeks.
  • Changes in asthma medications taken on regular basis in the previous 4 weeks.
  • Symptoms of asthma limited to seasonal allergen exposure.
  • History of clinically significant cardiac, renal, neurologic, hepatic, endocrine or pulmonary disease (except asthma), or laboratory testing abnormalities, whose sequelae and/or treatments can interfere with the results of the present study.
  • Evidence of pulmonary malformations.
  • Evidence of immunological deficiency (patients to be withdrawn if diagnosed during the study).
  • Cancer or any other chronic disease with prognosis \< 2 years.
  • Hypersensitivity to inhaled corticosteroids.
  • Participation in another trial in the last 4 weeks.
Healthy Volunteers
No

Protocol 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.

Study Locations

Location
Status
Location
Zaklad Alergologii Dzieciecej
Bialystok, Poland
Status
N/A
Location
Specjalistyczne Centrum Leczenia Dzieci i Mlodziezy
Krakow, Poland
Status
N/A
Location
Wojskovy Szpital Klinikzny
Krakow, Poland
Status
N/A
Location
Priwatna Pomoc Lekarska
Lodz, Poland
Status
N/A
Location
Alergovita, alergologia Dziecieca
Lublin, Poland
Status
N/A
Location
Priwtny Gabinet Pediatriczno - Alergologiczny
Rabka-Zdrój, Poland
Status
N/A
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Study Publications

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.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.