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| Sponsor: | ALTANA Pharma |
|---|---|
| Information provided by: | ALTANA Pharma |
| ClinicalTrials.gov Identifier: | NCT00163319 |
Purpose
The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Ciclesonide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Comparison of Inhaled Ciclesonide (640 Mcg/Day) and Fluticasone Propionate (1000 Mcg/Day) in Patients With Moderate and Severe Persistent Asthma |
| Estimated Enrollment: | 500 |
| Study Start Date: | November 2004 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Contacts and Locations
Hide Study Locations| Belgium | |
| Altana Pharma/Nycomed | |
| Bruxelles, Belgium, 1000 | |
| Altana Pharma/Nycomed | |
| Bruxelles, Belgium, 1040 | |
| Altana Pharma/Nycomed | |
| Jette, Belgium, 1090 | |
| Altana Pharma/Nycomed | |
| Bruxelles, Belgium, 1190 | |
| Altana Pharma/Nycomed | |
| Turnhout, Belgium, 2300 | |
| Altana Pharma/Nycomed | |
| Veurne, Belgium, 8630 | |
| Altana Pharma/Nycomed | |
| Namur, Belgium, 5000 | |
| Altana Pharma/Nycomed | |
| Maison-Saint-Gérard, Belgium, 5640 | |
| Altana Pharma/Nycomed | |
| Oostende, Belgium, 8400 | |
| Altana Pharma/Nycomed | |
| Halen, Belgium, 3545 | |
| France | |
| Altana Pharma/Nycomed | |
| Marseille, France, 13008 | |
| Altana Pharma/Nycomed | |
| Grasse, France, 6130 | |
| Altana Pharma/Nycomed | |
| Martigues Cedex, France, 13695 | |
| Altana Pharma/Nycomed | |
| La Rochelle, France, 17000 | |
| Altana Pharma/Nycomed | |
| Chauny CEDEX, France, 2303 | |
| Altana Pharma/Nycomed | |
| Nimes, France, 30900 | |
| Altana Pharma/Nycomed | |
| Montpellier Cedex, France, 34070 | |
| Altana Pharma/Nycomed | |
| Beziers, France, 34500 | |
| Altana Pharma/Nycomed | |
| Metz, France, 57000 | |
| Altana Pharma/Nycomed | |
| Vieux Conde, France, 59690 | |
| Altana Pharma/Nycomed | |
| Nice, France, 6000 | |
| Altana Pharma/Nycomed | |
| Aix En Provence, France, 13090 | |
| Altana Pharma/Nycomed | |
| Perpignan CEDEX, France, 66046 | |
| Altana Pharma/Nycomed | |
| Paris, France, 75014 | |
| Altana Pharma/Nycomed | |
| Montfermeil, France, 93370 | |
| Italy | |
| Altana Pharma/Nycomed | |
| Roma, Italy, 100 | |
| Altana Pharma/Nycomed | |
| Milano, Italy, 20122 | |
| Altana Pharma/Nycomed | |
| Milano, Italy, 20142 | |
| Altana Pharma/Nycomed | |
| Firenze, Italy, 50134 | |
| Altana Pharma/Nycomed | |
| Pavia, Italy, 27100 | |
| Altana Pharma/Nycomed | |
| Verona, Italy, 30012 | |
| Altana Pharma/Nycomed | |
| Pordenone, Italy, 33170 | |
| Altana Pharma/Nycomed | |
| Brescia, Italy, 25123 | |
| Altana Pharma/Nycomed | |
| Livorno, Italy, 57124 | |
| Altana Pharma/Nycomed | |
| Ancona, Italy, 60100 | |
| Altana Pharma/Nycomed | |
| Chieti, Italy, 66100 | |
| Altana Pharma/Nycomed | |
| Napoli, Italy, 80131 | |
| Altana Pharma/Nycomed | |
| Pirri-Cagliari, Italy, 9134 | |
| Altana Pharma/Nycomed | |
| Milazzo (ME), Italy, 98057 | |
| Netherlands | |
| Altana Pharma/Nycomed | |
| Harderwijk, Netherlands, 3844 DG | |
| Altana Pharma/Nycomed | |
| Haarlem, Netherlands, 2012 CE | |
| Altana Pharma/Nycomed | |
| Schiedam, Netherlands, 3116 BA | |
| Altana Pharma/Nycomed | |
| Utrecht, Netherlands, 3584 CX | |
| Altana Pharma/Nycomed | |
| Almere, Netherlands, 1315 RA | |
| Altana Pharma/Nycomed | |
| Veldhoven, Netherlands, 5504 DB | |
| Altana Pharma/Nycomed | |
| Helmond, Netherlands, 5707 HA | |
| Altana Pharma/Nycomed | |
| Heerlen, Netherlands, 6419 PC | |
| Spain | |
| Altana Pharma/Nycomed | |
| Córdoba, Spain, 14004 | |
| Altana Pharma/Nycomed | |
| Guadalajara, Spain, 19002 | |
| Altana Pharma/Nycomed | |
| San Sebastián, Spain, 20014 | |
| Altana Pharma/Nycomed | |
| Almeria, Spain, 4009 | |
| Altana Pharma/Nycomed | |
| Madrid, Spain, 28006 | |
| Altana Pharma/Nycomed | |
| Madrid, Spain, 28040 | |
| Altana Pharma/Nycomed | |
| Madrid, Spain, 28047 | |
| Altana Pharma/Nycomed | |
| Elche, Spain, 3203 | |
| Altana Pharma/Nycomed | |
| Madrid, Spain, 28001 | |
| Altana Pharma/Nycomed | |
| Valencia, Spain, 46014 | |
| Altana Pharma/Nycomed | |
| Valencia, Spain, 46017 | |
| Altana Pharma/Nycomed | |
| Requena, Spain, 46340 | |
| Altana Pharma/Nycomed | |
| Barcelona, Spain, 8222 | |
| Switzerland | |
| Altana Pharma/Nycomed | |
| La Chauxe-de-Fonds, Switzerland, 2300 | |
| Altana Pharma/Nycomed | |
| Bern, Switzerland, 3012 | |
| Altana Pharma/Nycomed | |
| Bellinzona, Switzerland, 6500 | |
| Altana Pharma/Nycomed | |
| Basel, Switzerland, 4031 | |
| Altana Pharma/Nycomed | |
| Bruderholz, Switzerland, 4101 | |
| Altana Pharma/Nycomed | |
| Münchenstein, Switzerland, 4142 | |
| Altana Pharma/Nycomed | |
| Münsingen, Switzerland, 3110 | |
| Altana Pharma/Nycomed | |
| Lugano, Switzerland, 6900 | |
| Altana Pharma/Nycomed | |
| Zürich, Switzerland, 8048 | |
| Altana Pharma/Nycomed | |
| Zürich, Switzerland, 8050 | |
| Altana Pharma/Nycomed | |
| Zürich, Switzerland, 8063 | |
| Altana Pharma/Nycomed | |
| Münsterlingen, Switzerland, 8596 | |
| United Kingdom | |
| Altana Pharma/Nycomed | |
| Solihull, United Kingdom, B91 2JL | |
| Altana Pharma/Nycomed | |
| Warminster Wiltshire, United Kingdom, BA12 9AA | |
| Altana Pharma/Nycomed | |
| Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ | |
| Altana Pharma/Nycomed | |
| Belfast, Irland, United Kingdom, BT15 3LL | |
| Altana Pharma/Nycomed | |
| Downpatrick, Northern Ireland, United Kingdom, BT30 6HY | |
| Altana Pharma/Nycomed | |
| Glengormley, United Kingdom, BT36 4PP | |
| Altana Pharma/Nycomed | |
| Watford, United Kingdom, WD25 0EA | |
| Altana Pharma/Nycomed | |
| Co. Antrim, United Kingdom, BT38 8TP | |
| Altana Pharma/Nycomed | |
| Belfast, United Kingdom, BT7 1DA | |
| Altana Pharma/Nycomed | |
| Nottingham, United Kingdom, NG3 7DQ | |
| Altana Pharma/Nycomed | |
| Nottingham, United Kingdom, NG5 1PB | |
| Altana Pharma/Nycomed | |
| Dronfield, United Kingdom, S18 1RU | |
| Altana Pharma/Nycomed | |
| Chesterfield Derbyshire, United Kingdom, S40 4TF | |
| Altana Pharma/Nycomed | |
| Maidenhead, Berks, United Kingdom, SI6 2LH | |
| Altana Pharma/Nycomed | |
| Chippenham, Wiltshire, United Kingdom, SN15 2SB | |
| Altana Pharma/Nycomed | |
| Hastings, United Kingdom, TN34 3EY | |
| Altana Pharma/Nycomed | |
| Glengormley Newtownabbey, United Kingdom, BT36 5EQ | |
| Principal Investigator: | Daniel Dusser, MD, PhD | Hospital COCHIN, Paris, France |
More Information
| Study ID Numbers: | BY9010/IT-101 |
| Study First Received: | September 12, 2005 |
| Last Updated: | July 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00163319 History of Changes |
| Health Authority: | Belgium: Ministère fédéral des Affaires sociales, de la Santé publique et de l'Environnement |
|
Asthma Ciclesonide Fluticasone propionate |
|
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Immune System Diseases Ciclesonide Physiological Effects of Drugs Anti-Asthmatic Agents Asthma Anti-Allergic Agents Pharmacologic Actions Lung Diseases, Obstructive |
Hypersensitivity Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents Respiratory Hypersensitivity |
