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| Sponsor: | Chiesi Farmaceutici S.p.A. |
|---|---|
| Information provided by: | Chiesi Farmaceutici S.p.A. |
| ClinicalTrials.gov Identifier: | NCT00528723 |
Purpose
The purpose of this trial is to verify if the test treatment BDP 250 mcg/salbutamol 100 mcg HFA pMDI fixed combination is non-inferior to BDP 250 mcg/salbutamol 100 mcg pMDI fixed combination given with the conventional CFC propellant (Clenil® Compositum 250, Chiesi Farmaceutici) in terms of Pulmonary Function (morning PEF).
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchial Asthma |
Drug: salbutamol 100 mcg Drug: BDP/salbutamol HFA pMDI Drug: BDP/salbutamol CFC pMDI |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Multicentre, Multinational, Randomised, Double Blind, Double Dummy, Active Drug Controlled, Parallel Group Study Design Clinical Trial of the Efficacy and Tolerability of Beclomethasone Dipropionate 250 Mcg Plus Salbutamol 100 Mcg in HFA pMDI Fixed Combination vs. Beclomethasone Dipropionate 250 Mcg Plus Salbutamol 100 Mcg in CFC pMDI (Clenil® Compositum 250) Fixed Combination in a 12-week Treatment Period of Adult Patients With Uncontrolled Asthma |
| Estimated Enrollment: | 180 |
| Study Start Date: | November 2007 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
BDP/salbutamol HFA pMDI
|
Drug: salbutamol 100 mcg
To be used as needed for symptom relief
Other Name: Ventolin®
Drug: BDP/salbutamol HFA pMDI
Patients assigned to BDP/salbutamol HFA pMDI will receive 2 puffs twice daily (morning and evening), for a total daily dose of BDP 1000 mcg/salbutamol 400 mcg, plus 2 puffs twice daily of alternative CFC placebo
|
|
Active Comparator: B
BDP/salbutamol CFC pMDI
|
Drug: salbutamol 100 mcg
To be used as needed for symptom relief
Other Name: Ventolin®
Drug: BDP/salbutamol CFC pMDI
Patients assigned to BDP/salbutamol CFC pMDI will receive 2 puffs twice daily (morning and evening), for a total daily dose of BDP 1000 mcg/salbutamol 400 mcg, plus 2 puffs twice daily of alternative HFA placebo
Other Name: Clenil® Compositum 250
|
Asthma is a chronic inflammatory disorder of the airways and a serious public health worldwide problem, affecting people of all ages, with an estimate of 300 millions affected individuals.When uncontrolled, asthma can place severe limits on daily life, and can sometimes be fatal.
There are two major classes of inhaled therapy for the treatment of reversible obstructive airways disease: antinflammatory agents and bronchodilators. In particular, BDP 250 mcg plus salbutamol 100 mcg in fixed combination is an effective and safe method to control symptoms of persistent asthma in adults.
This study has been designed to compare the efficacy, safety and tolerability of a new BDP 250 mcg/salbutamol 100 mcg HFA pMDI fixed combination with the same CFC-formulated fixed combination, which is on the market from some decades.The HFA propelled product is developed to replace the CFC formulation already marketed according to the European Union's Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (III/5378/93 - Final) in order to prevent from depletion of stratospheric ozone.
The primary objective of this trial is to demonstrate that the test treatment BDP 250 mcg/salbutamol 100 mcg HFA pMDI fixed combination is non-inferior to BDP 250 mcg/salbutamol 100 mcg pMDI fixed combination given with the conventional CFC propellant (Clenil® Compositum 250, Chiesi Farmaceutici) in terms of Pulmonary Function (morning PEF).
Given the aim of the study, the population to be monitored includes adult patients with persistent asthma according to the current guidelines. The treatment period will be preceded by a 2-week run-in period. Subjects satisfying all the inclusion and exclusion criteria will then enter the 12-week treatment period. Clinic visits will take place at the start and end of the run-in period, and after 2, 4, 8 and 12 weeks after randomisation.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| Servizio di Fisiopatologia Respiratoria Diagnostica Allergologica e Biologia Respiratoria Endoscopica e Toracica U.O.C. di Pneumologia Ospedale Orlandi | |
| Bussolengo, (vr), Italy, 37012 | |
| Unità Operativa Complessa di Clinica fisiologica e Pneumologia - Dipartimento di Medicina Interna e Specialità Mediche (DI.MI.) - Ospedale S. Martino e Cliniche Universitarie Convenzionate | |
| Genova, Italy, 16129 | |
| Unità Dipartimentale di Fisiopatologia Respiratoria -Dipartimento di Medicina Interna e Specialità Mediche (DI.MI.) - Ospedale S. Martino e Cliniche Universitarie Convenzionate | |
| Genova, Italy, 16129 | |
| Dipartimento di Medicina Ambientale e Sanità Pubblica-Sede di Medicina del Lavoro Servizio di Fisiopatologia Respiratoria | |
| Padova, Italy, 35127 | |
| Malattie dell'Apparato Respiratorio - Università degli Studi di Pisa Ospedale Cisanello | |
| Pisa, Italy, 56100 | |
| Russian Federation | |
| Central Clinical Hospital №1 OAO"RZD",Pulmonology Department | |
| Moscow, Russian Federation, 125315 | |
| City Clinical Hospital № 61, Pulmonology Department | |
| Moscow, Russian Federation, 119048 | |
| Clinical Hospital № 8, Pulmonology Department | |
| Yaroslavl, Russian Federation, 150030 | |
| Clinical Hospital № 2, Pulmonology Department | |
| Yaroslavl, Russian Federation, 150010 | |
| Regional Clinical Hospital, Department of Therapeutics of Post Graduate, Yaroslavl Medical Academy | |
| Yaroslavl, Russian Federation, 150062 | |
| Spain | |
| Hospital General Universitario Gregorio Marañón | |
| Madrid, Spain, 28007 | |
| Ukraine | |
| Department of Therapy of Kharkov Medical Academy of Postgraduate Education City Multifield Clinical Hospital n° 25 | |
| Kharkov, Ukraine, 61008 | |
| Pulmonological Department of the Institute of Therapy Ukrainian Academy of Medical Science | |
| Kharkov, Ukraine, 61035 | |
| Pulmonological Department # 2 City Clinical Hospital # 13 | |
| Kharkov, Ukraine, 61035 | |
| Department of General Practice - Family Medecine Medical Academy of post-graduate education. City Clinical Hospital N° 17 | |
| Kharkov, Ukraine, 61037 | |
| Pulmonological and Allergological Department of the Kharkov Regional Clinical Hospital | |
| Kharkov, Ukraine, 61022, | |
| Central Military Hospital of North Region. Pulmonological Department | |
| Kharkov, Ukraine, 61022 | |
| Department of propaedeutics of internal diseases #1. Kharkov State Medical University. | |
| Kharkov, Ukraine, 61022 | |
| Department of Diagnostic, Therapy and Clinical Pharmacology of Lung Disease of the Institute of Phtisiology and Pulmonology Academy of Medical Sciences of the Ukraine | |
| Kiev, Ukraine, 03680 | |
| Pulmonology Department of the Institute of Phthisiology and Pulmonology AMS of the Ukraine | |
| Kiev, Ukraine, 03680 | |
| Institute of Phthisiology and Pulmonology Acedemy of Medical Science of the Ukraine | |
| Kiev, Ukraine, 03680 | |
| Department of Pediatrics and laboratory diagnostics, Dniepropetrovsk State Medical Academy City Clinical Hospital No. 8. Pulmonology Department. 55 | |
| Krivoi Rog, Ukraine, 50082 | |
| General Therapy Clinic Central Military Clinical Hospital of Ministry of Defenses of Ukraine | |
| Kyiv, Ukraine, 01133 | |
| Department of Hospital Therapy of Lugansk State Medical Institute | |
| Lugansk, Ukraine, 91045 | |
| Department of Hospital Therapy, Lviv State Medical University named by Danylo Galytsky, Lviv Regional Clinical Hospital | |
| Lviv, Ukraine, 79010 | |
| Study Director: | Giovanni Cremonesi, M D | Chiesi Farmaceutici S.p.A. |
| Study Director: | Gabriele Nicolini, CPM | Chiesi Farmaceutici S.p.A. |
| Principal Investigator: | Luis Puente, Dr | Hospital General Universitario Gregorio Maranon, Madrid |
| Principal Investigator: | Giorgio Walter Canonica, Prof. | Ospedale S.Martino e Cliniche Universitarie Convenzionate, Genova, Italy |
| Principal Investigator: | Igor Bereznyakov, Prof. | Department of therapy of Kharkov Academy of Postgraduate Education, Kharkov, Ukraine |
More Information
| Responsible Party: | Nicolini Gabriele, Chiesi Farmaceutici |
| ClinicalTrials.gov Identifier: | NCT00528723 History of Changes |
| Other Study ID Numbers: | MC/PR/033004/002/06 |
| Study First Received: | September 11, 2007 |
| Last Updated: | April 21, 2010 |
| Health Authority: | Italy: Ministry of Health; Ukraine: Ministry of Health; Russia: Ministry of Public Health and Social Development; Spain: Ministry of Health and Consumption |
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beclomethasone as needed salbutamol wheezing |
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Albuterol Beclomethasone Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions |
Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Anti-Inflammatory Agents Glucocorticoids Hormones |