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:
Chiesi Farmaceutici S.p.A.
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
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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:
Drug Information available for:
Beclomethasone dipropionate
Albuterol
Levalbuterol
Levalbuterol hydrochloride
Albuterol sulfate
Beclomethasone dipropionate monohydrate
Levalbuterol tartrate
U.S. FDA Resources
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 |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497523
Locations
| Poland | |
| Zaklad Alergologii Dzieciecej | |
| Bialystok, Poland | |
| Wojskovy Szpital Klinikzny | |
| Krakow, Poland | |
| Specjalistyczne Centrum Leczenia Dzieci i Mlodziezy | |
| Krakow, Poland | |
| Priwatna Pomoc Lekarska | |
| Lodz, Poland | |
| Alergovita, alergologia Dziecieca | |
| Lublin, Poland | |
| Priwtny Gabinet Pediatriczno – Alergologiczny | |
| Rabka Zdroj, Poland | |
| Ukraine | |
| Dniepropetrovsk Regional Children's Clinical Hospital, State Medical Academy, Hospital Paediatric Department N.1 | |
| Dniepropetrovsk, Ukraine | |
| City Children's Clinical Hospital n. 2, Dniepropetrovs'k State Medical Academy, Department of preliminary study of childhood disesas | |
| 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 | |
| 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 | |
| Children’s Hospital “OHMATDYT” Department of Pediatrics N. 1 of Kyiv Medical Academy of Postgraduate Education | |
| 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 | |
| Regional Children Clinical Hospital. Department of Pulmonology. | |
| Zaporizhya, Ukraine | |
| City Clinical Hospital N. 1 , Zaporizzhya Medical Academy of post graduate education, department of paediatrics | |
| 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 Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Albuterol Beclomethasone Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions |
Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Anti-Inflammatory Agents Glucocorticoids Hormones |
ClinicalTrials.gov processed this record on June 13, 2013