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Sponsored by: |
Chiesi Farmaceutici S.p.A. |
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Information provided by: | Chiesi Farmaceutici S.p.A. |
ClinicalTrials.gov Identifier: | NCT00413387 |
The aim of this study was to compare the efficacy and tolerability of the fixed combination beclomethasone/formoterol pMDI with that of budesonide/formoterol dry powder via Turbuhaler.
Condition | Intervention | Phase |
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Bronchial Asthma |
Drug: beclomethasone dipropionate plus formoterol fumarate combination Drug: budesonide plus formoterol combination |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double Blind, Double Dummy, Multinational, Multicentre, Parallel-Group Design Clinical Trial of the Efficacy and Tolerability of CHF 1535 (Beclomethasone Dipropionate 100 µg + Formoterol 6 µg) pMDI Via HFA-134a Vs. Budesonide 160 µg + Formoterol 4,5 µg Dry Powder Via Turbuhaler® (Symbicort®) in the 12-Week Treatment of Adult Patients With Moderate to Severe Persistent Asthma |
Enrollment: | 219 |
Study Start Date: | September 2004 |
Study Completion Date: | October 2005 |
Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
chf1535
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Drug: beclomethasone dipropionate plus formoterol fumarate combination
100mcg beclomethasone diproprionate plus 6 mcg formoterol
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2: Active Comparator
Symbicort
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Drug: budesonide plus formoterol combination
200mcg budesonide plus 6 mcg formoterol
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Asthma is a chronic disease that is estimated to affect over 25 million people both in the U.S. and in Europe (i.e. approximately 10% of the total population). Pharmacological therapy is used to treat reversible airway obstruction, inflammation and hyper-reactivity. Medications include preventive treatments in forms of antinflammatory/antiallergic agents (i.e. glucocorticosteroids, leukotriene antagonists, cromolyn sodium) and reliever treatments, in forms of bronchodilators (i.e. β-adrenergic agonists, anticholinergics). In patients treated with inhaled glucocorticosteroids whose asthma is not fully controlled, national and international guidelines recommend a stepwise approach. Recent evidence-based clinical trials show that the addition of a LABA to inhaled glucocorticosteroids is more beneficial in terms of asthma control than increasing the dose of corticosteroids alone.
COMPARISONS: CHF 1535 (BECLOMETHASONE DIPROPIONATE 100 µg+ FORMOTEROL 6 µg) pMDI via HFA-134a compared to SYMBICORT (BUDESONIDE 160 µg + FORMOTEROL 4,5 µg).
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Clinical diagnosis of moderate to severe persistent asthma for at least 6 months, according to GINA revised version 2002 guidelines:
Asthma not adequately controlled with the current therapies, defined as presence of daily asthma symptoms > once a week and night-time asthma symptoms > twice a month, and daily use of short-acting β2-agonists. These findings are to be based on recent medical history and are to be confirmed in the 2-week run-in period.
Exclusion Criteria:
Inability to carry out pulmonary function testing;
Austria | |
Ambulance For Paediatric and Pulmonology | |
Wien, Austria | |
Poland | |
Uniwersytet Medyczny | |
Lodz, Poland | |
Nzoz "Medex"Poradnia Alergologiczna | |
Bielsko-Biala, Poland | |
Prywatny Gabinet Lekarski | |
Lodz, Poland | |
Centrum Alergologii | |
Lodz, Poland | |
Nzoz Lekarze Specjalisci | |
Wroclaw, Poland | |
Centrum Uslug Medycznych | |
Krakow, Poland | |
Ukraine | |
Kiev Medical Academy of Postdiploma Education. Department of Medical Genetics, Clinical Immunology and Allergology | |
Kiev, Ukraine | |
Internal Medicine Department, Dniepropetrovsk State Medical Academy. City Clinical Hospital no. 4 | |
Dniepropetrovsk, Ukraine | |
Kharkov Regional Clinical Hospital. Pulmonological and Allergological Department | |
Kharkov, Ukraine | |
Institute of Phthisiology and Pulmonology Academy of Medical Science of the Ukraine, Pulmonology Departement | |
Kiev, Ukraine | |
Institute of Therapy, Ukranian Academy of Medical Science. Pulmonological Departement | |
Kharkiv, Ukraine | |
Institute of Phthisiology and Pulmonology Academy of Medical Science of the Ukraine. Department of Diagnostic, Therapy and Clinical Pharmacology of Lung Diseases | |
Kiev, Ukraine |
Study Chair: | Leonardo M. Fabbri, MD | Department of Resipiratory Diseases - University of Modena and Reggio Emilia, Modena, Italy |
Study Chair: | Maurizio A. Vignola, MD | Institute of Lung Pathophysiology, National Research Council, Palermo, Italy |
Responsible Party: | Chiesi Farmaceutici ( Gabriele Nicolini ) |
Study ID Numbers: | MC/PR/033011/002/03 |
Study First Received: | December 18, 2006 |
Last Updated: | April 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00413387 History of Changes |
Health Authority: | Poland: Ministry of Health |
Asthma Combinations Inhaled therapy Corticosteroids |
Long acting bronchodilators Beclomethasone Formoterol Budesonide |
Anti-Inflammatory Agents Neurotransmitter Agents Adrenergic beta-Agonists Adrenergic Agents Bronchial Diseases Symbicort Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Asthma Beclomethasone |
Hormones Glucocorticoids Adrenergic Agonists Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Formoterol Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Bronchial Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Beclomethasone Hormones Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses |
Formoterol Immune System Diseases Adrenergic beta-Agonists Budesonide Asthma Anti-Asthmatic Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |