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 - Full Text View

Sponsored by:	Chiesi Farmaceutici S.p.A.
Information provided by:	Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:	NCT00497523

Purpose

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	Intervention	Phase
Bronchial Asthma	Drug: Beclomethasone dipropionate Drug: Beclomethasone dipropionate/Salbutamol combination Drug: Salbutamol	Phase III

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate Beclomethasone Beclomethasone dipropionate

U.S. FDA Resources

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

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:

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

Secondary Outcome 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 ]

Enrollment:	283
Study Start Date:	March 2006
Study Completion Date:	January 2007

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.

Eligibility

Ages Eligible for Study:	1 Year to 4 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497523

Locations

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

Sponsors and Collaborators

Chiesi Farmaceutici S.p.A.

Investigators

Study Chair:

Renato Cutrera, MD

Department of Pediatric Medicine, Children's Hospital and Research Institute Bambino Gesù, Rome, Italy

More Information

No publications provided

Study ID Numbers:	MC/PR/1404/002/05
Study First Received:	July 4, 2007
Last Updated:	July 5, 2007
ClinicalTrials.gov Identifier:	NCT00497523 History of Changes
Health Authority:	Poland: Ministry of Health

Keywords provided by Chiesi Farmaceutici S.p.A.:

Asthma
Young Children
Corticosteroids
Beclomethasone

Salbutamol
Beclomethasone/Salbutamol fixed combination
Suspension for nebulisation

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Bronchial Diseases
Hormone Antagonists
Albuterol
Hormones, Hormone Substitutes, and Hormone Antagonists
Asthma
Beclomethasone
Anti-Asthmatic Agents

Hormones
Glucocorticoids
Adrenergic Agonists
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Adrenergic Agents
Albuterol
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Beclomethasone
Reproductive Control Agents
Hormones
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive

Respiratory Tract Diseases
Tocolytic Agents
Therapeutic Uses
Immune System Diseases
Adrenergic beta-Agonists
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009