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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00497523
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : March 19, 2015
Information provided by:
Chiesi Farmaceutici S.p.A.

July 4, 2007
July 6, 2007
March 19, 2015
March 2006
Not Provided
Percentage of global (weeks 1-12) symptom-free days. [ Time Frame: weeks 1-12 ]
Same as current
Complete list of historical versions of study NCT00497523 on Archive Site
  • Frequency and number of exacerbations (defined as a worsening of symptoms of asthma requiring extra oral or inhaled corticosteroids) [ Time Frame: weeks 1-12 ]
  • Single clinical symptoms [ Time Frame: weeks 1-12 and every 2-week period ]
  • Nocturnal awakening due to symptoms of asthma [ Time Frame: weeks 1-12 and every 2-week period ]
  • Use of rescue nebulised therapy [ Time Frame: weeks 1-12 and every 2-week period ]
  • time to first exacerbation [ Time Frame: weeks 1-12 ]
Same as current
Not Provided
Not Provided
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
Double Blind, Multinational, Multicentre, Parallel-group, Placebo-controlled Design Trial of the Efficacy and Safety of Nebulised Beclometahsone Dipropionate (400 μg b.i.d.) Plus as Needed Salbutamol Versus as Needed Salbutamol or as Needed Salbutamol/Beclomethasone Fixed Combination, in the 12-week Treatment of Young Children With Asthma Symptoms
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.
Asthma is a chronic disease which is estimated to affect over 25 million people both in the US and Europe(i.e. approximately 10% of the total population).There is evidence that over the last 20 years prevalence has considerably increased, especially among children. The diagnosis of asthma in children may be difficult, largely because episodic wheezing and cough are among the common symptoms encountered in childhood illnesses, particularly in children under 3 years old.Although in these young children there is the possibility of over treatment, the episodes of wheezing may be reduced in intensity by the effective use of anti-inflammatory medications and bronchodilators rather than antibiotics. At present, pharmacological therapy is used to treat reversible airway obstruction, inflammation and hyperreactivity in both children and adults. Medications include preventive treatments in forms of antinflammatory/antiallergic agents (e.g. glucocorticosteroids, leukotriene antagonists, cromolyn sodium) and reliever treatments, in form of bronchodilators (e.g. β-adrenergic agonists, anticholinergics). Comparisons: Beclomethasone suspension for nebulisation (400 mcg U.D.V.) plus as needed salbutamol compared to placebo plus as needed salbutamol and to as needed salbutamol/beclomethasone fixed combination.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Bronchial Asthma
  • Drug: Beclomethasone dipropionate
  • Drug: Beclomethasone dipropionate/Salbutamol combination
  • Drug: Salbutamol
  • Experimental: Beclomethasone dipropionate
    Intervention: Drug: Beclomethasone dipropionate
  • Experimental: Beclomethasone dipropionate/Salbutamol combination
    Intervention: Drug: Beclomethasone dipropionate/Salbutamol combination
  • Active Comparator: Salbutamol
    Intervention: Drug: Salbutamol
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2007
Not Provided

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.
Sexes Eligible for Study: All
1 Year to 4 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
Poland,   Ukraine
Not Provided
Not Provided
Not Provided
Chiesi Farmaceutici S.p.A.
Not Provided
Study Chair: Renato Cutrera, MD Department of Pediatric Medicine, Children's Hospital and Research Institute Bambino Gesù, Rome, Italy
Chiesi Farmaceutici S.p.A.
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP