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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 |
Health Authority: | Poland: Ministry of Health |
asthma combinations inhaled therapy corticosteroids long acting bronchodilators |
salmeterol beclomethasone formoterol fluticasone |
Hypersensitivity Lung Diseases, Obstructive Salmeterol Respiratory Tract Diseases Bronchial Diseases Lung Diseases |
Hypersensitivity, Immediate Beclomethasone Formoterol Fluticasone Asthma Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Adrenergic beta-Agonists Adrenergic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents |
Anti-Allergic Agents Glucocorticoids Hormones Pharmacologic Actions Adrenergic Agonists Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents |