Efficacy and Safety of Ciclesonide Administered With or Without Different Spacers in Patients With Asthma (12 to 75 y) (BY9010/M1-145) - Full Text View

Purpose

The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).

Condition	Intervention	Phase
Asthma	Drug: Ciclesonide	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison of the Efficacy and Safety of 160 Mcg Ciclesonide Administered Once Daily in the Evening With or Without Different Spacer Types in Patients With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Ciclesonide

U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

FEV1.

Secondary Outcome Measures:

FVC
morning and evening PEF from diaries
asthma symptom score
use of rescue medication
number of patients with an asthma exacerbation
time to the first asthma exacerbation
percentage of days on which patient perceived asthma control
percentage of nocturnal awakening-free days
percentage of rescue medication-free days
percentage of asthma symptom-free days
adverse events
physical examination
vital signs
standard laboratory work-up
8 am serum cortisol.

Estimated Enrollment:	450
Study Start Date:	September 2005

Eligibility

Ages Eligible for Study:	12 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

Written informed consent
History of persistent bronchial asthma for at least 6 months
Good health with the exception of asthma

Main Exclusion Criteria:

Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
Smoking history with ≥10 cigarette pack years
Pregnancy
Intention to become pregnant
Breast feeding
Lack of safe contraception
Previous enrolment into the current study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163436

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Locations

Canada
Altana Pharma/Nycomed
La Malbaie, Quebec, Canada, G5A 1W7
Altana Pharma/Nycomed
London, Canada, N6A 5R9
Altana Pharma/Nycomed
London,ON, Canada, N6A1V2
Altana Pharma/Nycomed
Mississauga, Canada, L5B 1N1
Altana Pharma/Nycomed
Montreal, Quebec, Canada, H1V 1X5
Altana Pharma/Nycomed
Quebec City, Canada, G8T 7A1
Altana Pharma/Nycomed
Richmond Hill, Canada, L4S 1P3
Altana Pharma/Nycomed
Sainte-Foy, Quebec, Canada, G1V4G5
Altana Pharma/Nycomed
Saskatoon,SK, Canada, S7H 0W2
Altana Pharma/Nycomed
Scarborough,ON, Canada, M1B 4Z8
Altana Pharma/Nycomed
Toronto, Canada, M4P1P2
Altana Pharma/Nycomed
Vancouver, BC, Canada, V5Z 4E1
Altana Pharma/Nycomed
Winnipeg, Canada, R2M 5L9
Altana Pharma/Nycomed
Winnipeg MB, Canada, R3C 0N2
Altana Pharma/Nycomed
Woodstock, Canada, N4S 4G3
France
Altana Pharma/Nycomed
Aix En Provence, France, 13090
Altana Pharma/Nycomed
Chauny CEDEX, France, 2303
Altana Pharma/Nycomed
Ferolles-Attily, France, 77150
Altana Pharma/Nycomed
Grasse, France, 6130
Altana Pharma/Nycomed
La Rochelle, France, 17000
Altana Pharma/Nycomed
La Teste de Buch, France, 33260
Altana Pharma/Nycomed
Libourne, France, 33500
Altana Pharma/Nycomed
Lille, France, 59000
Altana Pharma/Nycomed
Martigues Cedex, France, 13695
Altana Pharma/Nycomed
Montbrison, France, 42600
Altana Pharma/Nycomed
Montpellier Cedex, France, 34070
Altana Pharma/Nycomed
Nice, France, 6000
Altana Pharma/Nycomed
Nimes, France, 30900
Altana Pharma/Nycomed
Saint Laurent Du Var, France, 6700
Altana Pharma/Nycomed
Saint-Quentin, France, 2100
Germany
Altana Pharma/Nycomed
Berlin, Germany, 13597
Altana Pharma/Nycomed
Berlin, Germany, 10717
Altana Pharma/Nycomed
Oschersleben, Germany, 39387
Altana Pharma/Nycomed
Rüdersdorf, Germany, 15562
Altana Pharma/Nycomed
Schwetzingen, Germany, 68723
Altana Pharma/Nycomed
Weinheim, Germany, 69469
Hungary
Altana Pharma/Nycomed
Balassagyarmat, Hungary, 2660
Altana Pharma/Nycomed
Budapest, Hungary, 1134
Altana Pharma/Nycomed
Budapest, Hungary, 1121
Altana Pharma/Nycomed
Budapet, Hungary, 1529
Altana Pharma/Nycomed
Gyula, Hungary, 5703
Altana Pharma/Nycomed
Komárom, Hungary, 2900
Altana Pharma/Nycomed
Miskolc, Hungary, 3501
Altana Pharma/Nycomed
Mosdós, Hungary, 7257
Altana Pharma/Nycomed
Nyiregyháza, Hungary, 4412
Altana Pharma/Nycomed
Pécs, Hungary, 7621
Altana Pharma/Nycomed
Szeged, Hungary, 6722
Altana Pharma/Nycomed
Székesfehérvár, Hungary, 8000
Altana Pharma/Nycomed
Érd, Hungary, 2030
India
Altana Pharma/Nycomed
Bangalore, India, 560 034
Altana Pharma/Nycomed
Chennai, India, 600 034
Altana Pharma/Nycomed
Coimbatore, India, 641004
Altana Pharma/Nycomed
Coimbatore, India, 641 014
Altana Pharma/Nycomed
Coimbatore, Tamilnadu, India, 641 044
Altana Pharma/Nycomed
Goa, India, 403 002
Altana Pharma/Nycomed
Gulbarga, India, 585105
Altana Pharma/Nycomed
Mumbai, India, 400008
Altana Pharma/Nycomed
Mumbai, Dadar (E), India, 400 014
Altana Pharma/Nycomed
Pune, India
Italy
Altana Pharma/Nycomed
Firenze, Italy, 50134
Altana Pharma/Nycomed
Milano, Italy, 20122
Altana Pharma/Nycomed
Milano, Italy, 20142
Altana Pharma/Nycomed
Milano, Italy, 20153
Altana Pharma/Nycomed
Napoli, Italy, 80131
Altana Pharma/Nycomed
Pordenone, Italy, 33170
Altana Pharma/Nycomed
Verona, Italy, 30012

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Principal Investigator:

Ekkehard Beck, Dr

IFG-Institut für Gesundheitsförderung GmbH, Rüdersdorf, Germany

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00163436 History of Changes
Other Study ID Numbers:	BY9010/M1-145
Study First Received:	September 12, 2005
Last Updated:	May 4, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Takeda Global Research & Development Center, Inc.:

Asthma
Ciclesonide

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

Hypersensitivity
Immune System Diseases
Ciclesonide
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013