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

NCT00497523 | Completed Phase 3

• 1 other identifier: MC/PR/1404/002/05
• Study Type: interventional
• Target: 283
• Locations: 2 countries
• Sites: 19

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.

Conditions

Bronchial Asthma

Keywords

Asthma; Young Children; Corticosteroids; Beclomethasone; Salbutamol; Beclomethasone/Salbutamol fixed combination; Suspension for nebulisation

Outcome Measures

Primary Outcomes (1)

• Percentage of global (weeks 1-12) symptom-free days.

  weeks 1-12

Secondary Outcomes (5)

• Frequency and number of exacerbations (defined as a worsening of symptoms of asthma requiring extra oral or inhaled corticosteroids)

  weeks 1-12

• Single clinical symptoms

  weeks 1-12 and every 2-week period

• Nocturnal awakening due to symptoms of asthma

  weeks 1-12 and every 2-week period

• Use of rescue nebulised therapy

  weeks 1-12 and every 2-week period

• time to first exacerbation

  weeks 1-12

Study Arms (3)

Beclomethasone dipropionate

EXPERIMENTAL

Drug: Beclomethasone dipropionate

Beclomethasone dipropionate/Salbutamol combination

EXPERIMENTAL

Drug: Beclomethasone dipropionate/Salbutamol combination

Salbutamol

ACTIVE COMPARATOR

Drug: Salbutamol

Interventions

Beclomethasone dipropionate DRUG

Beclomethasone dipropionate

Beclomethasone dipropionate/Salbutamol combination DRUG

Beclomethasone dipropionate/Salbutamol combination

Salbutamol DRUG

Salbutamol

Eligibility Criteria

• Age: 1 Year - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (19)

Zaklad Alergologii Dzieciecej

Bialystok, Poland

Location

Specjalistyczne Centrum Leczenia Dzieci i Mlodziezy

Krakow, Poland

Location

Wojskovy Szpital Klinikzny

Krakow, Poland

Location

Priwatna Pomoc Lekarska

Lodz, Poland

Location

Alergovita, alergologia Dziecieca

Lublin, Poland

Location

Priwtny Gabinet Pediatriczno - Alergologiczny

Rabka-Zdrój, Poland

Location

City Children's Clinical Hospital n. 2, Dniepropetrovs'k State Medical Academy, Department of preliminary study of childhood disesas

Dniepropetrovsk, Ukraine

Location

Dniepropetrovsk Regional Children's Clinical Hospital, State Medical Academy, Hospital Paediatric Department N.1

Dniepropetrovsk, Ukraine

Location

Department of Hospital Pediatrics, Kharkiv State Medical University Region Clinical Children's Hospital n. 2

Kharkiv, Ukraine

Location

Respiratory Diseases Children's Clinic, Institute of Phthisiology and Pulmonology,Academy of Medical Science of the Ukraine, Pulmonology

Kiev, Ukraine

Location

Children's Hospital "OHMATDYT" Department of Pediatrics N. 1 of Kyiv Medical Academy of Postgraduate Education

Kyiv, Ukraine

Location

Department of Clinical rehabilitation of children with bodily diseasesof Institute of Pediatrics, Obstetrics and Gynecology

Kyiv, Ukraine

Location

Institute of Pediatrics, Obstetrics and Gynecology. Department of Children's Pulmonology Diseases and Ecological Problems of Health

Kyiv, Ukraine

Location

Department of Paediatric and Neonatology, Odessa State Medical University, Odessa Region Clinical Children's Hospital

Odesa, Ukraine

Location

Poltava regional children's clinical hospital, Ukranian stomatological academy, department of pediatrics

Poltava, Ukraine

Location

Pediatrics Crimean State Medical University Pulmonology, Department of Republican Clinical Children's Hospital

Simferopol, Ukraine

Location

Children's clinical hospital N.1, Zaporizzhya Medical Academy of post graduate education, department of pediatrics

Zaporizhya, Ukraine

Location

City Clinical Hospital N. 1 , Zaporizzhya Medical Academy of post graduate education, department of paediatrics

Zaporizhya, Ukraine

Location

Regional Children Clinical Hospital. Department of Pulmonology.

Zaporizhya, Ukraine

Location

Related 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):1463-1471. doi: 10.1111/j.1398-9995.2009.02134.x.

  PMID: 19772514 RESULT

• 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.

  PMID: 21859484 RESULT

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone; Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Renato Cutrera, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 4, 2007
• First Posted: July 6, 2007
• Study Start: March 1, 2006
• Study Completion: January 1, 2007
• Last Updated: August 3, 2020

Record last verified: 2020-07

Locations

PL (6); UA (13)