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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

This study has been completed.
Sponsor:
Information provided by:
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT00497523
First received: July 4, 2007
Last updated: July 5, 2007
Last verified: July 2007
  Purpose

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.


Condition Intervention Phase
Bronchial Asthma
Drug: Beclomethasone dipropionate
Drug: Beclomethasone dipropionate/Salbutamol combination
Drug: Salbutamol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Percentage of global (weeks 1-12) symptom-free days. [ Time Frame: weeks 1-12 ]

Secondary Outcome Measures:
  • Frequency and number of exacerbations (defined as a worsening of symptoms of asthma requiring extra oral or inhaled corticosteroids) [ Time Frame: weeks 1-12 ]
  • Single clinical symptoms [ Time Frame: weeks 1-12 and every 2-week period ]
  • Nocturnal awakening due to symptoms of asthma [ Time Frame: weeks 1-12 and every 2-week period ]
  • Use of rescue nebulised therapy [ Time Frame: weeks 1-12 and every 2-week period ]
  • time to first exacerbation [ Time Frame: weeks 1-12 ]

Enrollment: 283
Study Start Date: March 2006
Study Completion Date: January 2007
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

Ages Eligible for Study:   1 Year to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497523

Locations
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, Poland
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, Ukraine
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Study Chair: Renato Cutrera, MD Department of Pediatric Medicine, Children's Hospital and Research Institute Bambino Gesù, Rome, Italy
  More Information

No publications provided by Chiesi Farmaceutici S.p.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00497523     History of Changes
Other Study ID Numbers: MC/PR/1404/002/05
Study First Received: July 4, 2007
Last Updated: July 5, 2007
Health Authority: Poland: Ministry of Health

Keywords provided by Chiesi Farmaceutici S.p.A.:
Asthma
Young Children
Corticosteroids
Beclomethasone
Salbutamol
Beclomethasone/Salbutamol fixed combination
Suspension for nebulisation

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Albuterol
Beclomethasone
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014