Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Beclomethasone dipropionate
• Drug: Beclomethasone dipropionate/Salbutamol combination
• Drug: Salbutamol

Primary Measures

• Percentage of global (weeks 1-12) symptom-free days.
  • Time Frame: weeks 1-12
    

Secondary Measures

• 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
    

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Year

Maximum Age for this Clinical Trial: 4 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Chiesi Farmaceutici S.p.A.

Overall Clinical Trial Officials and Contacts

Renato Cutrera, MD Study Chair Department of Pediatric Medicine, Children's Hospital and Research Institute Bambino Gesù, Rome, Italy  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00497523

Study ID Number: MC/PR/1404/002/05

ClinicalTrials.gov Identifier: NCT00497523

Health Authority: Poland: Ministry of Health