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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.

Brief 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.

Condition or disease Intervention/treatment Phase
Bronchial Asthma Drug: Beclomethasone dipropionate Drug: Beclomethasone dipropionate/Salbutamol combination Drug: Salbutamol Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 283 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : March 2006
Actual Study Completion Date : January 2007

Arm Intervention/treatment
Experimental: Beclomethasone dipropionate Drug: Beclomethasone dipropionate
Experimental: Beclomethasone dipropionate/Salbutamol combination Drug: Beclomethasone dipropionate/Salbutamol combination
Active Comparator: Salbutamol Drug: Salbutamol

Primary Outcome Measures :
  1. Percentage of global (weeks 1-12) symptom-free days. [ Time Frame: weeks 1-12 ]

Secondary Outcome Measures :
  1. Frequency and number of exacerbations (defined as a worsening of symptoms of asthma requiring extra oral or inhaled corticosteroids) [ Time Frame: weeks 1-12 ]
  2. Single clinical symptoms [ Time Frame: weeks 1-12 and every 2-week period ]
  3. Nocturnal awakening due to symptoms of asthma [ Time Frame: weeks 1-12 and every 2-week period ]
  4. Use of rescue nebulised therapy [ Time Frame: weeks 1-12 and every 2-week period ]
  5. time to first exacerbation [ Time Frame: weeks 1-12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00497523

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Zaklad Alergologii Dzieciecej
Bialystok, Poland
Specjalistyczne Centrum Leczenia Dzieci i Mlodziezy
Krakow, Poland
Wojskovy Szpital Klinikzny
Krakow, Poland
Priwatna Pomoc Lekarska
Lodz, Poland
Alergovita, alergologia Dziecieca
Lublin, Poland
Priwtny Gabinet Pediatriczno - Alergologiczny
Rabka Zdroj, Poland
City Children's Clinical Hospital n. 2, Dniepropetrovs'k State Medical Academy, Department of preliminary study of childhood disesas
Dniepropetrovsk, Ukraine
Dniepropetrovsk Regional Children's Clinical Hospital, State Medical Academy, Hospital Paediatric Department N.1
Dniepropetrovsk, Ukraine
Department of Hospital Pediatrics, Kharkiv State Medical University Region Clinical Children's Hospital n. 2
Kharkiv, Ukraine
Respiratory Diseases Children's Clinic, Institute of Phthisiology and Pulmonology,Academy of Medical Science of the Ukraine, Pulmonology
Kiev, Ukraine
Children's Hospital "OHMATDYT" Department of Pediatrics N. 1 of Kyiv Medical Academy of Postgraduate Education
Kyiv, Ukraine
Department of Clinical rehabilitation of children with bodily diseasesof Institute of Pediatrics, Obstetrics and Gynecology
Kyiv, Ukraine
Institute of Pediatrics, Obstetrics and Gynecology. Department of Children's Pulmonology Diseases and Ecological Problems of Health
Kyiv, Ukraine
Department of Paediatric and Neonatology, Odessa State Medical University, Odessa Region Clinical Children's Hospital
Odessa, Ukraine
Poltava regional children's clinical hospital, Ukranian stomatological academy, department of pediatrics
Poltava, Ukraine
Pediatrics Crimean State Medical University Pulmonology, Department of Republican Clinical Children's Hospital
Simferopol, Ukraine
Children's clinical hospital N.1, Zaporizzhya Medical Academy of post graduate education, department of pediatrics
Zaporizhya, Ukraine
City Clinical Hospital N. 1 , Zaporizzhya Medical Academy of post graduate education, department of paediatrics
Zaporizhya, Ukraine
Regional Children Clinical Hospital. Department of Pulmonology.
Zaporizhya, Ukraine
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
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Study Chair: Renato Cutrera, MD Department of Pediatric Medicine, Children's Hospital and Research Institute Bambino Gesù, Rome, Italy

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00497523     History of Changes
Other Study ID Numbers: MC/PR/1404/002/05
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Chiesi Farmaceutici S.p.A.:
Young Children
Beclomethasone/Salbutamol fixed combination
Suspension for nebulisation

Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists