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

NCT ID: NCT00497523

Last Updated: 2020-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 283 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-01-31

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.

Conditions

Bronchial Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Beclomethasone dipropionate

Group Type: EXPERIMENTAL

Beclomethasone dipropionate

Intervention Type: DRUG

Beclomethasone dipropionate/Salbutamol combination

Group Type: EXPERIMENTAL

Beclomethasone dipropionate/Salbutamol combination

Intervention Type: DRUG

Salbutamol

Group Type: ACTIVE_COMPARATOR

Salbutamol

Intervention Type: DRUG

Interventions

Beclomethasone dipropionate

Intervention Type: DRUG

Beclomethasone dipropionate/Salbutamol combination

Intervention Type: DRUG

Salbutamol

Intervention Type: DRUG

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Renato Cutrera, MD

Role: STUDY_CHAIR

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

Locations

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-Zdrój, , 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

Odesa, , 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

Countries

Poland; Ukraine

References

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.

Reference Type: RESULT

PMID: 19772514 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21859484 (View on PubMed)

Other Identifiers

MC/PR/1404/002/05

Identifier Type: -

Identifier Source: org_study_id