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

Bronchial Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497523
• Other study ID #: MC/PR/1404/002/05
• Status: Completed
• Phase: Phase 3
• Start date: March 2006
• Est. completion date: January 2007

Study information

• Verified date: July 2020
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 4 Years

Eligibility

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 ß2-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.

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Drug:
• Beclomethasone dipropionate

• Beclomethasone dipropionate/Salbutamol combination

• Salbutamol

Locations

Country	Name	City	State
Poland	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
Ukraine	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

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Countries where clinical trial is conducted

Poland,  Ukraine, 

References & Publications (2)

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):1463-71. doi: 10.11 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of global (weeks 1-12) symptom-free days.		weeks 1-12
Secondary	Frequency and number of exacerbations (defined as a worsening of symptoms of asthma requiring extra oral or inhaled corticosteroids)		weeks 1-12
Secondary	Single clinical symptoms		weeks 1-12 and every 2-week period
Secondary	Nocturnal awakening due to symptoms of asthma		weeks 1-12 and every 2-week period
Secondary	Use of rescue nebulised therapy		weeks 1-12 and every 2-week period
Secondary	time to first exacerbation		weeks 1-12