Back to resultsEfficacy 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
Primary Purpose
Bronchial Asthma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Beclomethasone dipropionate
Beclomethasone dipropionate/Salbutamol combination
Salbutamol
Sponsored by
About this trial
This is an interventional treatment trial for Bronchial Asthma focused on measuring Asthma, Young Children, Corticosteroids, Beclomethasone, Salbutamol, Beclomethasone/Salbutamol fixed combination, Suspension for nebulisation
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- Evidence of immunological deficiency (patients to be withdrawn if diagnosed during the study).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.
Sites / Locations
- Zaklad Alergologii Dzieciecej
- Specjalistyczne Centrum Leczenia Dzieci i Mlodziezy
- Wojskovy Szpital Klinikzny
- Priwatna Pomoc Lekarska
- Alergovita, alergologia Dziecieca
- Priwtny Gabinet Pediatriczno - Alergologiczny
- City Children's Clinical Hospital n. 2, Dniepropetrovs'k State Medical Academy, Department of preliminary study of childhood disesas
- Dniepropetrovsk Regional Children's Clinical Hospital, State Medical Academy, Hospital Paediatric Department N.1
- Department of Hospital Pediatrics, Kharkiv State Medical University Region Clinical Children's Hospital n. 2
- Respiratory Diseases Children's Clinic, Institute of Phthisiology and Pulmonology,Academy of Medical Science of the Ukraine, Pulmonology
- Children's Hospital "OHMATDYT" Department of Pediatrics N. 1 of Kyiv Medical Academy of Postgraduate Education
- Department of Clinical rehabilitation of children with bodily diseasesof Institute of Pediatrics, Obstetrics and Gynecology
- Institute of Pediatrics, Obstetrics and Gynecology. Department of Children's Pulmonology Diseases and Ecological Problems of Health
- Department of Paediatric and Neonatology, Odessa State Medical University, Odessa Region Clinical Children's Hospital
- Poltava regional children's clinical hospital, Ukranian stomatological academy, department of pediatrics
- Pediatrics Crimean State Medical University Pulmonology, Department of Republican Clinical Children's Hospital
- Children's clinical hospital N.1, Zaporizzhya Medical Academy of post graduate education, department of pediatrics
- City Clinical Hospital N. 1 , Zaporizzhya Medical Academy of post graduate education, department of paediatrics
- Regional Children Clinical Hospital. Department of Pulmonology.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Beclomethasone dipropionate
Beclomethasone dipropionate/Salbutamol combination
Salbutamol
Arm Description
Outcomes
Primary Outcome Measures
Percentage of global (weeks 1-12) symptom-free days.
Secondary Outcome Measures
Frequency and number of exacerbations (defined as a worsening of symptoms of asthma requiring extra oral or inhaled corticosteroids)
Single clinical symptoms
Nocturnal awakening due to symptoms of asthma
Use of rescue nebulised therapy
time to first exacerbation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00497523
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chiesi Farmaceutici S.p.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma
Keywords
Asthma, Young Children, Corticosteroids, Beclomethasone, Salbutamol, Beclomethasone/Salbutamol fixed combination, Suspension for nebulisation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
283 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Beclomethasone dipropionate
Arm Type
Experimental
Arm Title
Beclomethasone dipropionate/Salbutamol combination
Arm Type
Experimental
Arm Title
Salbutamol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Beclomethasone dipropionate
Intervention Type
Drug
Intervention Name(s)
Beclomethasone dipropionate/Salbutamol combination
Intervention Type
Drug
Intervention Name(s)
Salbutamol
Primary Outcome Measure Information:
Title
Percentage of global (weeks 1-12) symptom-free days.
Time Frame
weeks 1-12
Secondary Outcome Measure Information:
Title
Frequency and number of exacerbations (defined as a worsening of symptoms of asthma requiring extra oral or inhaled corticosteroids)
Time Frame
weeks 1-12
Title
Single clinical symptoms
Time Frame
weeks 1-12 and every 2-week period
Title
Nocturnal awakening due to symptoms of asthma
Time Frame
weeks 1-12 and every 2-week period
Title
Use of rescue nebulised therapy
Time Frame
weeks 1-12 and every 2-week period
Title
time to first exacerbation
Time Frame
weeks 1-12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato Cutrera, MD
Organizational Affiliation
Department of Pediatric Medicine, Children's Hospital and Research Institute Bambino Gesù, Rome, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Zaklad Alergologii Dzieciecej
City
Bialystok
Country
Poland
Facility Name
Specjalistyczne Centrum Leczenia Dzieci i Mlodziezy
City
Krakow
Country
Poland
Facility Name
Wojskovy Szpital Klinikzny
City
Krakow
Country
Poland
Facility Name
Priwatna Pomoc Lekarska
City
Lodz
Country
Poland
Facility Name
Alergovita, alergologia Dziecieca
City
Lublin
Country
Poland
Facility Name
Priwtny Gabinet Pediatriczno - Alergologiczny
City
Rabka Zdroj
Country
Poland
Facility Name
City Children's Clinical Hospital n. 2, Dniepropetrovs'k State Medical Academy, Department of preliminary study of childhood disesas
City
Dniepropetrovsk
Country
Ukraine
Facility Name
Dniepropetrovsk Regional Children's Clinical Hospital, State Medical Academy, Hospital Paediatric Department N.1
City
Dniepropetrovsk
Country
Ukraine
Facility Name
Department of Hospital Pediatrics, Kharkiv State Medical University Region Clinical Children's Hospital n. 2
City
Kharkiv
Country
Ukraine
Facility Name
Respiratory Diseases Children's Clinic, Institute of Phthisiology and Pulmonology,Academy of Medical Science of the Ukraine, Pulmonology
City
Kiev
Country
Ukraine
Facility Name
Children's Hospital "OHMATDYT" Department of Pediatrics N. 1 of Kyiv Medical Academy of Postgraduate Education
City
Kyiv
Country
Ukraine
Facility Name
Department of Clinical rehabilitation of children with bodily diseasesof Institute of Pediatrics, Obstetrics and Gynecology
City
Kyiv
Country
Ukraine
Facility Name
Institute of Pediatrics, Obstetrics and Gynecology. Department of Children's Pulmonology Diseases and Ecological Problems of Health
City
Kyiv
Country
Ukraine
Facility Name
Department of Paediatric and Neonatology, Odessa State Medical University, Odessa Region Clinical Children's Hospital
City
Odessa
Country
Ukraine
Facility Name
Poltava regional children's clinical hospital, Ukranian stomatological academy, department of pediatrics
City
Poltava
Country
Ukraine
Facility Name
Pediatrics Crimean State Medical University Pulmonology, Department of Republican Clinical Children's Hospital
City
Simferopol
Country
Ukraine
Facility Name
Children's clinical hospital N.1, Zaporizzhya Medical Academy of post graduate education, department of pediatrics
City
Zaporizhya
Country
Ukraine
Facility Name
City Clinical Hospital N. 1 , Zaporizzhya Medical Academy of post graduate education, department of paediatrics
City
Zaporizhya
Country
Ukraine
Facility Name
Regional Children Clinical Hospital. Department of Pulmonology.
City
Zaporizhya
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
19772514
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.
Results Reference
result
PubMed Identifier
21859484
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.
Results Reference
result
Learn more about this trial
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
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