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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Foster
|
Drug: Beclomethasone plus formoterol fixed combination
100+6 pMDI
|
|
Active Comparator: 2
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| Bulgaria | |
| Clinic of Pulmonology, UMHAT "Sveti Georgi" | |
| Plovdiv, Bulgaria, 4002 | |
| First Department of Pulmonology, Regional Dispensery of Pulmonology and Phtisiatric Diseases with Stationary (RDPPDS) | |
| Ruse, Bulgaria, 7002 | |
| Clinic of Pulmonology, University Hospital "Lozenetz" | |
| Sofia, Bulgaria | |
| First Internal Clinic, Endocrinology and Pulmonology Department MHAT | |
| Stara Zagora, Bulgaria, 6000 | |
| Italy | |
| U.O.C. S.Anna e S. Sebastiano - Malattie dell'apparato respiratorio | |
| Caserta, Italy | |
| Ospedale S. Camillo de Lellis - U.O.C. Pneumologia | |
| Chieti, Italy | |
| Ospedale Cardarelli - Fisiopatologia Respiratoria | |
| Napoli, Italy | |
| CNR - Dipartimento di Fisiopatologia Respiratoria | |
| Palermo, Italy | |
| Ukraine | |
| Department of Hospital Pediatrics Crimean State Medical University. Pulmonology Department of Republican Clinical Children's Hospital | |
| Crimea, Ukraine, 95004 | |
| Pulmonological Department of the Institute of Therapy, Ukrainian Academy of Medical Sciences | |
| Kharkiv, Ukraine, 61035 | |
| Pulmonological Department #2 | |
| Kharkiv, Ukraine, 61035 | |
| Pulmonological and Allergological Department of the Kharkov Regional Clinical Hospital | |
| Kharkov, Ukraine, 61022 | |
| Department of General Practice- Family medicine. Medical Academy of postgraduate education. | |
| Kharkov, Ukraine | |
| Department of Diagnostic, Therapy and Clinical Pharmacology of Lung Diseases of the Institute of Phthisiology and Pulmonology Academy of Medical Science of the Ukraine | |
| Kiev, Ukraine, 03680 | |
| Institute of pthysiology and pulmonology Academy of medical science of the Ukraine. | |
| Kiev, Ukraine, 03680 | |
| Pulmonology Department of the Institute of Phthisiology and Pulmonology AMS of the Ukraine | |
| Kiev, Ukraine, 03680 | |
| Clinical Hospital 8, Department of pediatrics and clinical laboratories | |
| Kriviy Rig, Ukraine | |
| Department of Hospital Therapy of Lugansk State Medical Institute. Lugansk Regional Clinical Hospital | |
| Lugansk, Ukraine, 91045 | |
| Principal Investigator: | Pierluigi Paggiaro, MD | Ospedale Cisanello, Pisa |
More Information
| Responsible Party: | Gabriele Nicolini, Chiesi Farmaceutici |
| ClinicalTrials.gov Identifier: | NCT00497237 History of Changes |
| Other Study ID Numbers: | MC/PR/033011/005/06 |
| Study First Received: | July 4, 2007 |
| Last Updated: | April 21, 2010 |
| 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 |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone Beclomethasone Formoterol Salmeterol Anti-Inflammatory Agents Therapeutic Uses |
Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents |