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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: | NCT00394368 |
The aim of this study was to compare the efficacy and tolerability of the fixed combination beclomethasone/formoterol pMDI with that of fluticasone/salmeterol pMDI in patients with moderate to severe asthma
Condition | Intervention | Phase |
---|---|---|
Bronchial Asthma |
Drug: beclomethasone dipropionate plus formoterol fumarate combination Drug: fluticasone propionate plus salmeterol xinafoate combination |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | DOUBLE BLIND, 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. FLUTICASONE 125 µg + SALMETEROL 25 µg pMDI (SERETIDE®) IN THE 12-WEEK TREATMENT OF ADULT PATIENTS WITH MODERATE TO SEVERE PERSISTENT ASTHMA |
Estimated Enrollment: | 180 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | September 2005 |
Asthma is a chronic disease that is estimated to affect over 25 million people both in the U.S. and 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 form 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 FLUTICASONE 125 µg + SALMETEROL 25 µg pMDI (SERETIDE®)
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 (11):
Exclusion Criteria:
Poland | |
Nzoz "Krakow Poludnie" Pulmonologic Policlinic | |
Krakow, Poland | |
Outpatients Department of Allergology "Medcare" | |
Gdansk, Poland | |
Nzoz "Non nocere" | |
Gdansk, Poland | |
Dolnoslaski Centre of Medical Diagnostic "Dolmed" | |
Wroclaw, Poland | |
Private Institute of Health and Beauty | |
Warszawa, Poland | |
Specialist Allergy Center All-Med | |
Krakow, Poland | |
Ukraine | |
Kharkiv City Clinical Hospital 13 Pulmonological Department | |
Kharkiv, Ukraine | |
Department of Hospital Therapy of Lugansk, State Medical Institute Lugansk, Regional Clinical Hospital | |
Lugansk, Ukraine | |
Institute of Phthisiology and Pulmonology, Academy of Medical Science of Ukraine, Depatment of Diagnostic, Therapy and Clinical Pharmacology of Lung Disease | |
Kiev, Ukraine | |
Department Therapy of Bronchopulmonary Pathology in Adults, Crimean Republic Research Institute of Physical Methods of Therapy and Medical Climatology | |
Yalta, Ukraine | |
Republican Clinical Hospital Institute of Phthisiology and Pulmonology Academy of Medical Science of Ukraine, Clinical Functional Department | |
Kiev, Ukraine | |
Republican Clinical Hospital, Institute of Phthisiology and Pulmonology, Academy of Medical Science of Ukraine, Pulmonology Department | |
Kiev, Ukraine |
Study Chair: | Leonardo M. Fabbri, MD | Department of Respiartory Diseases - University of Modena and Reggio Emilia, Modena, Italy |
Study Chair: | Maurizio A. Vignola, MD | Institute of Lung Pathophysiology, National Research Council, Palermo, Italy |
Study ID Numbers: | MC/PR/033011/001/03 |
Study First Received: | October 30, 2006 |
Last Updated: | October 30, 2006 |
ClinicalTrials.gov Identifier: | NCT00394368 History of Changes |
Health Authority: | Poland: Ministry of Health |
asthma combinations inhaled therapy corticosteroids long acting bronchodilators |
salmeterol beclomethasone formoterol fluticasone |
Anti-Inflammatory Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Beclomethasone Hormones Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Formoterol |
Fluticasone Salmeterol Adrenergic beta-Agonists Asthma Anti-Asthmatic Agents Anti-Allergic Agents Glucocorticoids Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchial Diseases Adrenergic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Beclomethasone Hormones Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses |
Formoterol Fluticasone Dermatologic Agents Salmeterol Immune System Diseases Adrenergic beta-Agonists Asthma Anti-Asthmatic Agents Anti-Allergic Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents |