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| Sponsor: | Chiesi Farmaceutici S.p.A. |
|---|---|
| Information provided by: | Chiesi Farmaceutici S.p.A. |
| ClinicalTrials.gov Identifier: | NCT00497237 |
Purpose
Asthma is a serious global health problem. People of all ages in countries throughout the world are affected by this chronic airway disorder that can be severe and sometimes fatal. The prevalence of asthma is increasing everywhere, especially among children.According to international guidelines, once control of asthma is achieved and maintained for at least 3 months, a gradual reduction of the maintenance therapy should be tried in order to identify the minimum therapy required to maintain control. This will help reduce the risk of side effects and enhance patient adherence to the treatment plan.
Reduction of therapy in patients on combination therapy should begin with a reduction in the dose of inhaled glucocorticosteroid.1 The present study is designed to evaluate if patients with controlled asthma treated with FP 1000 mcg + salmeterol 100 mcg daily can be stepped down. Stepping-down will be attempted with two medications: a new combination of extrafine beclomethasone dipropionate 400 mcg + formoterol 24 mcg daily (test medication, Foster™) and, alternatively, fluticasone propionate 500 mcg + salmeterol 100 mcg daily(reference medication) without losing asthma control.If this hypothesis will be confirmed, the present study will demonstrate that asthma control can be maintained with less than half the dose of inhaled corticosteroid and with less medical costs.
Given the aims of this study, the population to be monitored includes adult patients with moderate persistent asthma, which can be defined controlled according to the current guidelines under standard stabilised treatment. The intended treatment duration is therefore designed to ensure that good control of asthma is firmly achieved before stepping down the treatment (8 weeks run-in period), but also that the condition of the patients are followed long enough (24 weeks comparative treatment period) to ensure that a new stable condition is also obtained and properly monitored.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Beclomethasone plus formoterol fixed combination Drug: Fluticasone plus salmeterol fixed combination |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Prospective, Randomised, Open-Label, Multicentre, Active Drug Controlled, Parallel Group Design Clinical Trial of the Efficacy and Safety of Beclomethasone Dipropionate 400 Mcg + Formoterol 24 Mcg pMDI Via HFA-134a (Foster™) vs. Fluticasone Propionate 500 Mcg + Salmeterol Xinafoate 100 Mcg DPI (Seretide Diskus®) in the 6 Months Stepdown Treatment of Adult Patients With Controlled Asthma |
| Estimated Enrollment: | 382 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Foster
|
Drug: Beclomethasone plus formoterol fixed combination
100+6 pMDI
|
|
2: Active Comparator
Seretide
|
Drug: Fluticasone plus salmeterol fixed combination
diskus 250/50
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At the end of run in period (Week 8+0; Visit 3), patients will be recruited into the treatment period and randomized to treatment if they meet the following criterion:
Exclusion Criteria:
At the end of run in period (Week 8+0; Visit 3), patients will not be randomized to treatment if they do not completely meet the definition of "controlled asthma". These subjects will be considered screening failures and will not count against the planned number to be recruited.
Contacts and Locations| Contact: Pierluigi Paggiaro, MD | 050995366 |
| Bulgaria | |
| Clinic of Pulmonology, University Hospital "Lozenetz" | Not yet recruiting |
| Sofia, Bulgaria | |
| Contact: Georgi Hinkov, Dr. 00359 2 960 7557 drhinkov@abv.bg | |
| Clinic of Pulmonology, UMHAT "Sveti Georgi" | Not yet recruiting |
| Plovdiv, Bulgaria, 4002 | |
| Contact: Vladimir Hodzhev, Prof 0035932 602990 vahodgev@abv.bg | |
| First Internal Clinic, Endocrinology and Pulmonology Department MHAT | Not yet recruiting |
| Stara Zagora, Bulgaria, 6000 | |
| Contact: Dimo Mitev Dimov, Dr 00359 42 66 44 93 dmdimov@yahoo.com | |
| First Department of Pulmonology, Regional Dispensery of Pulmonology and Phtisiatric Diseases with Stationary (RDPPDS) | Not yet recruiting |
| Ruse, Bulgaria, 7002 | |
| Contact: Hristo Metev, Dr 00359 82 82 38 79 h_metev_2003@yahoo.com | |
| Italy | |
| CNR - Dipartimento di Fisiopatologia Respiratoria | Recruiting |
| Palermo, Italy | |
| Principal Investigator: Mark Gjomarkaj, MD | |
| Ospedale S. Camillo de Lellis - U.O.C. Pneumologia | Recruiting |
| Chieti, Italy | |
| Principal Investigator: Fernando De Benedetto, MD | |
| Ospedale Cardarelli - Fisiopatologia Respiratoria | Recruiting |
| Napoli, Italy | |
| Principal Investigator: Fausto De Michele, MD | |
| U.O.C. S.Anna e S. Sebastiano - Malattie dell'apparato respiratorio | Recruiting |
| Caserta, Italy | |
| Contact: , MD | |
| Principal Investigator: Riccardo Cioffi, MD | |
| Ukraine | |
| Pulmonological Department of the Institute of Therapy, Ukrainian Academy of Medical Sciences | Not yet recruiting |
| Kharkiv, Ukraine, 61035 | |
| Contact: Yefimov Volodymyr, Dr. +38 057 775 15 51 igs@therapy.ac.kharkov.ua | |
| Clinical Hospital 8, Department of pediatrics and clinical laboratories | Not yet recruiting |
| Kriviy Rig, Ukraine | |
| Contact: Svitlana Mokia-Serbina, Prof. +380564365303 litvinova_2008@ukr.net | |
| Department of Diagnostic, Therapy and Clinical Pharmacology of Lung Diseases of the Institute of Phthisiology and Pulmonology Academy of Medical Science of the Ukraine | Not yet recruiting |
| Kiev, Ukraine, 03680 | |
| Contact: Lyudmyla Yashyna, Prof. +38 044 275 0568 diagnost@ifp.kiev.ua | |
| Institute of pthysiology and pulmonology Academy of medical science of the Ukraine. | Not yet recruiting |
| Kiev, Ukraine, 03680 | |
| Contact: Viktoria Kostromina, Prof. +38 044 275 3602 child@ifp.kiev.ua | |
| Department of Hospital Therapy of Lugansk State Medical Institute. Lugansk Regional Clinical Hospital | Not yet recruiting |
| Lugansk, Ukraine, 91045 | |
| Contact: Olena Olenitskaya, Dr. +380642580979 | |
| Department of General Practice- Family medicine. Medical Academy of postgraduate education. | Not yet recruiting |
| Kharkov, Ukraine | |
| Contact: Olexiy Korzh, Prof. + 38 057 738 70 18 alexeykorzh@mail.ru | |
| Pulmonological Department #2 | Not yet recruiting |
| Kharkiv, Ukraine, 61035 | |
| Contact: Dr. Viktor Blazhko +38 057 721 09 48 blazhkopulm@mail.ru | |
| Department of Hospital Pediatrics Crimean State Medical University. Pulmonology Department of Republican Clinical Children's Hospital | Not yet recruiting |
| Crimea, Ukraine, 95004 | |
| Contact: T. Kobets, Prof. + 38 0652 25 34 26 kobez@yandex.ru | |
| Pulmonological and Allergological Department of the Kharkov Regional Clinical Hospital | Not yet recruiting |
| Kharkov, Ukraine, 61022 | |
| Contact: Z. Semydotska, Prof. +38 057 705 0209 vade_mecum2001@yahoo.com | |
| Pulmonology Department of the Institute of Phthisiology and Pulmonology AMS of the Ukraine | Not yet recruiting |
| Kiev, Ukraine, 03680 | |
| Contact: Feshchenko Yuriy, Prof. +380442750402 admin@ifp.kiev.ua | |
| Principal Investigator: | Pierluigi Paggiaro, MD | Ospedale Cisanello, Pisa |
More Information
| Responsible Party: | Chiesi Farmaceutici ( Gabriele Nicolini ) |
| Study ID Numbers: | MC/PR/033011/005/06 |
| Study First Received: | July 4, 2007 |
| Last Updated: | January 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00497237 History of Changes |
| Health Authority: | Italy: Ministry of Health; Bulgaria: Ministry of Health; Spain: Ministry of Health and Consumption; Ukraine: Ministry of Health |
|
Asthma Stepdown Beclomethasone Formoterol Corticosteroids |
|
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 |