Clinical trial NCT00497523: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchial Asthma
Keywords: Asthma
Young Children
Corticosteroids
Beclomethasone
Salbutamol
Beclomethasone/Salbutamol fixed combination
Suspension for nebulisation
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2007-07-06
Enrollment: 283
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Percentage of global (weeks 1-12) symptom-free days.
timeFrame: weeks 1-12
Secondary outcomes:
measure: Frequency and number of exacerbations (defined as a worsening of symptoms of asthma requiring extra oral or inhaled corticosteroids)
timeFrame: weeks 1-12
measure: Single clinical symptoms
timeFrame: weeks 1-12 and every 2-week period
measure: Nocturnal awakening due to symptoms of asthma
timeFrame: weeks 1-12 and every 2-week period
measure: Use of rescue nebulised therapy
timeFrame: weeks 1-12 and every 2-week period
measure: time to first exacerbation
timeFrame: weeks 1-12
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: Zaklad Alergologii Dzieciecej
city: Krakow
country: Poland
facility: Specjalistyczne Centrum Leczenia Dzieci i Mlodziezy
city: Krakow
country: Poland
facility: Wojskovy Szpital Klinikzny
city: Lodz
country: Poland
facility: Priwatna Pomoc Lekarska
city: Lublin
country: Poland
facility: Alergovita, alergologia Dziecieca
city: Rabka Zdroj
country: Poland
facility: Priwtny Gabinet Pediatriczno - Alergologiczny
city: Dniepropetrovsk
country: Ukraine
facility: City Children's Clinical Hospital n. 2, Dniepropetrovs'k State Medical Academy, Department of preliminary study of childhood disesas
city: Dniepropetrovsk
country: Ukraine
facility: Dniepropetrovsk Regional Children's Clinical Hospital, State Medical Academy, Hospital Paediatric Department N.1
city: Kharkiv
country: Ukraine
facility: Department of Hospital Pediatrics, Kharkiv State Medical University Region Clinical Children's Hospital n. 2
city: Kiev
country: Ukraine
facility: Respiratory Diseases Children's Clinic, Institute of Phthisiology and Pulmonology,Academy of Medical Science of the Ukraine, Pulmonology
city: Kyiv
country: Ukraine
facility: Children's Hospital "OHMATDYT" Department of Pediatrics N. 1 of Kyiv Medical Academy of Postgraduate Education
city: Kyiv
country: Ukraine
facility: Department of Clinical rehabilitation of children with bodily diseasesof Institute of Pediatrics, Obstetrics and Gynecology
city: Kyiv
country: Ukraine
facility: Institute of Pediatrics, Obstetrics and Gynecology. Department of Children's Pulmonology Diseases and Ecological Problems of Health
city: Odessa
country: Ukraine
facility: Department of Paediatric and Neonatology, Odessa State Medical University, Odessa Region Clinical Children's Hospital
city: Poltava
country: Ukraine
facility: Poltava regional children's clinical hospital, Ukranian stomatological academy, department of pediatrics
city: Simferopol
country: Ukraine
facility: Pediatrics Crimean State Medical University Pulmonology, Department of Republican Clinical Children's Hospital
city: Zaporizhya
country: Ukraine
facility: Children's clinical hospital N.1, Zaporizzhya Medical Academy of post graduate education, department of pediatrics
city: Zaporizhya
country: Ukraine
facility: City Clinical Hospital N. 1 , Zaporizzhya Medical Academy of post graduate education, department of paediatrics
city: Zaporizhya
country: Ukraine
facility: Regional Children Clinical Hospital. Department of Pulmonology.
Study officials:
affiliation: Department of Pediatric Medicine, Children's Hospital and Research Institute Bambino Gesù, Rome, Italy
name: Renato Cutrera, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.