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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: | NCT00528723 |
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 |
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Bronchial Asthma |
Drug: salbutamol 100 mcg Drug: BDP/salbutamol HFA pMDI Drug: BDP/salbutamol CFC pMDI |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
BDP/salbutamol HFA pMDI
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Drug: salbutamol 100 mcg
To be used as needed for symptom relief
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
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B: Active Comparator
BDP/salbutamol CFC pMDI
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Drug: salbutamol 100 mcg
To be used as needed for symptom relief
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
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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.
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Unità Operativa Complessa di Clinica fisiologica e Pneumologia - Dipartimento di Medicina Interna e Specialità Mediche (DI.MI.) - Ospedale S. Martino e Cliniche Universitarie Convenzionate | Recruiting |
Genova, Italy, 16129 | |
Contact: Giorgio Walter Canonica, Prof. +39-0105553513 gcanonica@qubisoft.it | |
Principal Investigator: Giorgio Walter Canonica, Prof. | |
Unità Dipartimentale di Fisiopatologia Respiratoria -Dipartimento di Medicina Interna e Specialità Mediche (DI.MI.) - Ospedale S. Martino e Cliniche Universitarie Convenzionate | Recruiting |
Genova, Italy, 16129 | |
Contact: Vito Brusasco, Prof. +39-0103537690 Vito.Brusasco@unige.it | |
Principal Investigator: Vito Brusasco, Prof. | |
Dipartimento di Medicina Ambientale e Sanità Pubblica-Sede di Medicina del Lavoro Servizio di Fisiopatologia Respiratoria | Recruiting |
Padova, Italy, 35127 | |
Contact: Piero Maestrelli, Prof. +39-0498212541 piero.maestrelli@unipd.it | |
Contact: Piero Maestrelli, Prof. +39-0498212541 piero.maestrelli@unipd.it | |
Principal Investigator: Piero Maestrelli, Prof. | |
Malattie dell'Apparato Respiratorio - Università degli Studi di Pisa Ospedale Cisanello | Recruiting |
Pisa, Italy, 56100 | |
Contact: Pierluigi Paggiaro, Prof. 050-995266 ext +39 ppaggiaro@qubisoft.it | |
Principal Investigator: Pierluigi Paggiaro, Prof. | |
Italy, (VR) | |
Servizio di Fisiopatologia Respiratoria Diagnostica Allergologica e Biologia Respiratoria Endoscopica e Toracica U.O.C. di Pneumologia Ospedale Orlandi | Recruiting |
Bussolengo, (VR), Italy, 37012 | |
Contact: Roberto Dal Negro, Dr. +39-0456769193 rdalnegro@ulss22.ven.it | |
Principal Investigator: Roberto Dal Negro, Dr. | |
Russian Federation | |
Central Clinical Hospital №1 OAO"RZD",Pulmonology Department | Not yet recruiting |
Moscow, Russian Federation, 125315 | |
Contact: Sergey Evgenievich Mikhaylov, Dr 495 151 35 41 ext +7 serg.mikh@mail.ru | |
Principal Investigator: Sergey Evgenievich Mikhaylov, Dr | |
Regional Clinical Hospital, Department of Therapeutics of Post Graduate, Yaroslavl Medical Academy | Not yet recruiting |
Yaroslavl, Russian Federation, 150062 | |
Contact: Oleg Anatolievich Khrustalev, Prof. 4852 24 80 16 ext +7 khrust@yrh.yar.ru | |
Principal Investigator: .Oleg Anatolievich Khrustalev, Prof | |
Clinical Hospital № 8, Pulmonology Department | Not yet recruiting |
Yaroslavl, Russian Federation, 150030 | |
Contact: Natalia Petrovna Shilkina, Prof. 4852 44 54 04 ext + 7 kpvb@pochta.ru | |
Principal Investigator: Natalia Petrovna Shilkina, Prof. | |
Clinical Hospital № 2, Pulmonology Department | Not yet recruiting |
Yaroslavl, Russian Federation, 150010 | |
Contact: Alexander Leonidovich Khokhlov, Prof. 4852 46 09 35 ext +7 alekskhokhlov@yandex.ru | |
Principal Investigator: Alexander Leonidovich Khokhlov, Prof. | |
City Clinical Hospital № 61, Pulmonology Department | Not yet recruiting |
Moscow, Russian Federation, 119048 | |
Contact: Alexander Semenovich Solomatin, Dr. 495 246 75 18 ext +7 protosha@mail.ru | |
Principal Investigator: Alexander Semenovich Solomatin, Dr. | |
Spain | |
Servicio de Neumologia Hospital Universitario La Paz | Not yet recruiting |
Madrid, Spain, 28046 | |
Contact: Francisco Garcia-Rio, Dr. +34-917277000 fgr01m@jazzfree.com | |
Principal Investigator: Francisco Garcia-Rio, Dr. | |
Hospital Central de la Defensa Gomez Ulla | Not yet recruiting |
Madrid, Spain, 28047 | |
Contact: Javier Jareño, Dr. +34-914228000 | |
Principal Investigator: Javier Jareño, Dr. | |
Hospital General Universitario Gregorio Marañón | Not yet recruiting |
Madrid, Spain, 28007 | |
Contact: Luis Puente, Dr. +34915868000 lpuente@separ.es | |
Principal Investigator: Luis Puente, Dr. | |
Ukraine | |
Department of Hospital Therapy, Lviv State Medical University named by Danylo Galytsky, Lviv Regional Clinical Hospital | Not yet recruiting |
Lviv, Ukraine, 79010 | |
Contact: Orest. O. Abrahamovych, Prof 0322 76 97 63 ext +38 docorest@sc.net.ua | |
Principal Investigator: Orest O. Abrahamovych, Prof. | |
Pulmonological Department of the Institute of Therapy Ukrainian Academy of Medical Science | Recruiting |
Kharkov, Ukraine, 61035 | |
Contact: Vladimir Vyacheslavovivh Yefimov, Dr. 0577751551 ext + 38 | |
Principal Investigator: Vladimir Vyacheslavovivh Yefimov, Dr. | |
Pulmonological Department # 2 City Clinical Hospital # 13 | Recruiting |
Kharkov, Ukraine, 61035 | |
Contact: Victor Ivanovich Blazhko, Dr. 0577210948 ext +38 | |
Principal Investigator: Victor Ivanovich Blazhko, Dr. | |
Pulmonology Department of the Institute of Phthisiology and Pulmonology AMS of the Ukraine | Recruiting |
Kiev, Ukraine, 03680 | |
Contact: Yuriy Ivanovich Feshchenko, Prof. 0442758328 ext +38 | |
Principal Investigator: Yuriy Ivanovich Feshchenko, Prof. | |
Department of General Practice - Family Medecine Medical Academy of post-graduate education. City Clinical Hospital N° 17 | Recruiting |
Kharkov, Ukraine, 61037 | |
Contact: Alexey. N. Korzh, Prof. 0577153421 ext +38 | |
Principal Investigator: Alexey. N. Korzh, Prof. | |
Department of Diagnostic, Therapy and Clinical Pharmacology of Lung Disease of the Institute of Phtisiology and Pulmonology Academy of Medical Sciences of the Ukraine | Recruiting |
Kiev, Ukraine, 03680 | |
Contact: Lyudmyla Aleksandrovna Yashyna, Prof. 0442750568 ext +38 | |
Principal Investigator: Lyudmyla Aleksandrovna Yashyna, Prof. | |
Institute of Phthisiology and Pulmonology Acedemy of Medical Science of the Ukraine | Recruiting |
Kiev, Ukraine, 03680 | |
Contact: Viktoria Pavlovna Kostromina, Prof. 0442753602 ext +38 | |
Principal Investigator: Viktoria Pavlovna Kostromina, Prof. | |
Department of Hospital Therapy of Lugansk State Medical Institute | Recruiting |
Lugansk, Ukraine, 91045 | |
Contact: Vladimir Ignatyevich Putintsev, Prof. 0642580979 ext +38 | |
Principal Investigator: Vladimir Ignatyevich Putintsev, Prof. | |
Department of Pediatrics and laboratory diagnostics, Dniepropetrovsk State Medical Academy City Clinical Hospital No. 8. Pulmonology Department. 55 | Not yet recruiting |
Krivoi Rog, Ukraine, 50082 | |
Contact: Mokia Serbina, prof 0564 36 62 82 ext + 38 dekan@alba.dp.ua | |
Principal Investigator: Mokia Serbina, Prof. | |
Pulmonological and Allergological Department of the Kharkov Regional Clinical Hospital | Not yet recruiting |
Kharkov, Ukraine, 61022, | |
Contact: Semydotska, Prof. 057 705 0209 ext +38 vade_mecum2001@yahoo.com | |
Principal Investigator: Semydotska, Prof. | |
Department of propaedeutics of internal diseases #1. Kharkov State Medical University. | Not yet recruiting |
Kharkov, Ukraine, 61022 | |
Contact: Olga М Kovalyova, Prof. 057 732 33 44 ext +38 svokov@ic.kharkov.ua | |
Principal Investigator: Olga М. Kovalyova, Prof. | |
General Therapy Clinic Central Military Clinical Hospital of Ministry of Defenses of Ukraine | Not yet recruiting |
Kyiv, Ukraine, 01133 | |
Contact: Sergiy S. Simonov, Dr. 044 529 26 21 ext +38 ssimonov54@mail.ru | |
Principal Investigator: Sergiy S. Simonov, Dr. | |
Central Military Hospital of North Region. Pulmonological Department | Not yet recruiting |
Kharkov, Ukraine, 61022 | |
Contact: Svetlana Prof. Olshtynska 057 702 49 64 ext +38 nrv@nevod.nt.ua | |
Principal Investigator: Svetlana Olshtynska, Prof | |
Department of Therapy of Kharkov Medical Academy of Postgraduate Education City Multifield Clinical Hospital n° 25 | Recruiting |
Kharkov, Ukraine, 61008 | |
Contact: Igor G. Bereznyakov, Prof. 0572955947 ext +38 | |
Principal Investigator: Igor G. Bereznyakov, Prof. |
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 |
Responsible Party: | Chiesi Farmaceutici ( Nicolini Gabriele ) |
Study ID Numbers: | MC/PR/033004/002/06 |
Study First Received: | September 11, 2007 |
Last Updated: | June 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00528723 |
Health Authority: | Italy: Ministry of Health; Ukraine: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Spain: Ministry of Health and Consumption |
beclomethasone as needed salbutamol wheezing |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Albuterol |
Hypersensitivity, Immediate Beclomethasone Asthma Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Bronchial Diseases Immune System Diseases Adrenergic beta-Agonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents |
Reproductive Control Agents Hormones Glucocorticoids Adrenergic Agonists Pharmacologic Actions Tocolytic Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |