Efficacy of Ciclesonide During the Cold Season in Patients Older Than 12 Years With Persistent Asthma (ARTIST)

Ciclesonide for the Therapy of Asthma During the Cold Season.

The aim of the study is to evaluate the efficacy of ciclesonide in patients with persistent asthma over 3 months, especially in the cold season. Ciclesonide will be inhaled by a metered-dose inhaler. The study will provide further data on safety and tolerability of ciclesonide.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Ciclesonide

• Study Type: Observational
• Enrollment (Anticipated): 2100

Contacts and Locations

Study Locations

• Germany
  • Adendorf, Germany, 21365
    • "Nycomed Deutschland GmbH"
  • Arnstadt, Germany, 99310
    • "Nycomed Deutschland GmbH"
  • Auerbach, Germany, 08209
    • "Nycomed Deutschland GmbH"
  • Augsburg, Germany, 86150
    • "Nycomed Deutschland GmbH"
  • Backnang, Germany, 71522
    • "Nycomed Deutschland GmbH"
  • Bad Bramstedt, Germany, 24576
    • "Nycomed Deutschland GmbH"
  • Bad Kreuznach, Germany, 55543
    • "Nycomed Deutschland GmbH"
  • Bad Lippspringe, Germany, 33175
    • "Nycomed Deutschland GmbH"
  • Bad Neuenahr-Ahrweiler, Germany, 53474
    • "Nycomed Deutschland GmbH"
  • Bad Neustadt, Germany, 97616
    • "Nycomed Deutschland GmbH"
  • Bad Soden, Germany, 65812
    • "Nycomed Deutschland GmbH"
  • Bad Tölz, Germany, 83646
    • "Nycomed Deutschland GmbH"
  • Bautzen, Germany, 02625
    • "Nycomed Deutschland GmbH"
  • Bergisch Gladbach, Germany, 51429
    • "Nycomed Deutschland GmbH"
  • Berlin, Germany, 10247
    • "Nycomed Deutschland GmbH"
  • Berlin, Germany, 10365
    • "Nycomed Deutschland GmbH"
  • Berlin, Germany, 10717
    • "Nycomed Deutschland GmbH"
  • Berlin, Germany, 12627
    • "Nycomed Deutschland GmbH"
  • Berlin, Germany, 10117
    • "Nycomed Deutschland GmbH"
  • Berlin, Germany, 10367
    • "Nycomed Deutschland GmbH"
  • Berlin, Germany, 10625
    • "Nycomed Deutschland GmbH"
  • Berlin, Germany, 10711
    • "Nycomed Deutschland GmbH"
  • Berlin, Germany, 12165
    • "Nycomed Deutschland GmbH"
  • Berlin, Germany, 12687
    • "Nycomed Deutschland GmbH"
  • Berlin, Germany, 13057
    • "Nycomed Deutschland GmbH"
  • Berlin, Germany, 13086
    • "Nycomed Deutschland GmbH"
  • Berlin, Germany, 13156
    • "Nycomed Deutschland GmbH"
  • Berlin, Germany, 13465
    • "Nycomed Deutschland GmbH"
  • Berlin, Germany, 14059
    • "Nycomed Deutschland GmbH"
  • Bietigheim-Bissingen, Germany, 74321
    • "Nycomed Deutschland GmbH"
  • Braunschweig, Germany, 38106
    • "Nycomed Deutschland GmbH"
  • Braunschweig, Germany, 38100
    • "Nycomed Deutschland GmbH"
  • Bredstedt, Germany, 25821
    • "Nycomed Deutschland GmbH"
  • Breisach, Germany, 79206
    • "Nycomed Deutschland GmbH"
  • Bremen, Germany, 28203
    • "Nycomed Deutschland GmbH"
  • Bremen, Germany, 28237
    • "Nycomed Deutschland GmbH"
  • Bremerhaven, Germany, 27570
    • "Nycomed Deutschland GmbH"
  • Bremerhaven, Germany, 27574
    • "Nycomed Deutschland GmbH"
  • Bruchsal, Germany, 76646
    • "Nycomed Deutschland GmbH"
  • Bröckel, Germany, 29356
    • "Nycomed Deutschland GmbH"
  • Burgwedel, Germany, 30938
    • "Nycomed Deutschland GmbH"
  • Castrop-Rauxel, Germany, 44579
    • "Nycomed Deutschland GmbH"
  • Coburg, Germany, 96450
    • "Nycomed Deutschland GmbH"
  • Cottbus, Germany, 03050
    • "Nycomed Deutschland GmbH"
  • Delitzsch, Germany, 04509
    • "Nycomed Deutschland GmbH"
  • Dortmund, Germany, 44135
    • "Nycomed Deutschland GmbH"
  • Dortmund, Germany, 44287
    • "Nycomed Deutschland GmbH"
  • Dresden, Germany, 01099
    • "Nycomed Deutschland GmbH"
  • Dresden, Germany, 01307
    • "Nycomed Deutschland GmbH"
  • Duisburg, Germany, 47051
    • "Nycomed Deutschland GmbH"
  • Düren, Germany, 52349
    • "Nycomed Deutschland GmbH"
  • Düsseldorf, Germany, 40237
    • "Nycomed Deutschland GmbH"
  • Eisenach, Germany, 99817
    • "Nycomed Deutschland GmbH"
  • Erfurt, Germany, 99086
    • "Nycomed Deutschland GmbH"
  • Eschwege, Germany, 37269
    • "Nycomed Deutschland GmbH"
  • Finsterwalde, Germany, 03238
    • "Nycomed Deutschland GmbH"
  • Flensburg, Germany, 24937
    • "Nycomed Deutschland GmbH"
  • Frankfurt, Germany, 60322
    • "Nycomed Deutschland GmbH"
  • Freising, Germany, 85354
    • "Nycomed Deutschland GmbH"
  • Friedrichshafen, Germany, 88045
    • "Nycomed Deutschland GmbH"
  • Fürstenwalde, Germany, 15517
    • "Nycomed Deutschland GmbH"
  • Garmisch-Partenkirchen, Germany, 82467
    • "Nycomed Deutschland GmbH"
  • Gelsenkirchen, Germany, 45881
    • "Nycomed Deutschland GmbH"
  • Gotha, Germany, 99867
    • "Nycomed Deutschland GmbH"
  • Greiz, Germany, 07973
    • "Nycomed Deutschland GmbH"
  • Hagen, Germany, 58089
    • "Nycomed Deutschland GmbH"
  • Halle, Germany, 06108
    • "Nycomed Deutschland GmbH"
  • Halle, Germany, 06114
    • "Nycomed Deutschland GmbH"
  • Hamburg, Germany, 20255
    • "Nycomed Deutschland GmbH"
  • Hamburg, Germany, 21077
    • "Nycomed Deutschland GmbH"
  • Hamburg, Germany, 22587
    • "Nycomed Deutschland GmbH"
  • Hannover, Germany, 30159
    • "Nycomed Deutschland GmbH"
  • Hartha, Germany, 04746
    • "Nycomed Deutschland GmbH"
  • Haßloch, Germany, 67454
    • "Nycomed Deutschland GmbH"
  • Heidelberg, Germany, 69115
    • "Nycomed Deutschland GmbH"
  • Heilbronn, Germany, 74072
    • "Nycomed Deutschland GmbH"
  • Herne, Germany, 44649
    • "Nycomed Deutschland GmbH"
  • Herten, Germany, 45699
    • "Nycomed Deutschland GmbH"
  • Hoyerswerda, Germany, 02977
    • "Nycomed Deutschland GmbH"
  • Husum, Germany, 25813
    • "Nycomed Deutschland GmbH"
  • Höchstadt, Germany, 91315
    • "Nycomed Deutschland GmbH"
  • Jettingen, Germany, 71131
    • "Nycomed Deutschland GmbH"
  • Karlsruhe, Germany, 76227
    • "Nycomed Deutschland GmbH"
  • Kiel, Germany, 24106
    • "Nycomed Deutschland GmbH"
  • Kiel, Germany, 24148
    • "Nycomed Deutschland GmbH"
  • Koblenz, Germany, 56068
    • "Nycomed Deutschland GmbH"
  • Konstanz, Germany, 78462
    • "Nycomed Deutschland GmbH"
  • Köln, Germany, 50679
    • "Nycomed Deutschland GmbH"
  • Köln, Germany, 50999
    • "Nycomed Deutschland GmbH"
  • Laatzen, Germany, 30880
    • "Nycomed Deutschland GmbH"
  • Leipzig, Germany, 04207
    • "Nycomed Deutschland GmbH"
  • Leipzig, Germany, 04103
    • "Nycomed Deutschland GmbH"
  • Leipzig, Germany, 04275
    • "Nycomed Deutschland GmbH"
  • Leipzig, Germany, 04357
    • "Nycomed Deutschland GmbH"
  • Limburg, Germany, 65549
    • "Nycomed Deutschland GmbH"
  • Lohfelden, Germany, 34253
    • "Nycomed Deutschland GmbH"
  • Mainz, Germany, 55122
    • "Nycomed Deutschland GmbH"
  • Mainz, Germany, 55129
    • "Nycomed Deutschland GmbH"
  • Mannheim, Germany, 68161
    • "Nycomed Deutschland GmbH"
  • Mannheim, Germany, 68165
    • "Nycomed Deutschland GmbH"
  • Marburg, Germany, 35037
    • "Nycomed Deutschland GmbH"
  • Markkleeberg, Germany, 04416
    • "Nycomed Deutschland GmbH"
  • Menden, Germany, 58706
    • "Nycomed Deutschland GmbH"
  • Minden, Germany, 32423
    • "Nycomed Deutschland GmbH"
  • Moers, Germany, 47441
    • "Nycomed Deutschland GmbH"
  • Mühlhausen, Germany, 99974
    • "Nycomed Deutschland GmbH"
  • München, Germany, 80336
    • "Nycomed Deutschland GmbH"
  • Neu Wulmstorf, Germany, 21629
    • "Nycomed Deutschland GmbH"
  • Neubrandenburg, Germany, 17034
    • "Nycomed Deutschland GmbH"
  • Neumarkt, Germany, 92318
    • "Nycomed Deutschland GmbH"
  • Neuruppin, Germany, 16816
    • "Nycomed Deutschland GmbH"
  • Neuss, Germany, 41460
    • "Nycomed Deutschland GmbH"
  • Nordhausen, Germany, 99734
    • "Nycomed Deutschland GmbH"
  • Oberursel, Germany, 61440
    • "Nycomed Deutschland GmbH"
  • Offenburg, Germany, 77654
    • "Nycomed Deutschland GmbH"
  • Osnabrück, Germany, 49074
    • "Nycomed Deutschland GmbH"
  • Plauen, Germany, 08523
    • "Nycomed Deutschland GmbH"
  • Radebeul, Germany, 01445
    • "Nycomed Deutschland GmbH"
  • Rendsburg, Germany, 24768
    • "Nycomed Deutschland GmbH"
  • Rosengarten, Germany, 21224
    • "Nycomed Deutschland GmbH"
  • Rostock, Germany, 18109
    • "Nycomed Deutschland GmbH"
  • Saalfeld, Germany, 07318
    • "Nycomed Deutschland GmbH"
  • Saarbrücken, Germany, 66111
    • "Nycomed Deutschland GmbH"
  • Saarlouis, Germany, 66740
    • "Nycomed Deutschland GmbH"
  • Salzgitter, Germany, 38226
    • "Nycomed Deutschland GmbH"
  • Schmölln, Germany, 04626
    • "Nycomed Deutschland GmbH"
  • Schwalmtal, Germany, 41366
    • "Nycomed Deutschland GmbH"
  • Schwarmstedt, Germany, 29690
    • "Nycomed Deutschland GmbH"
  • Schwerin, Germany, 19057
    • "Nycomed Deutschland GmbH"
  • Siegen, Germany, 57072
    • "Nycomed Deutschland GmbH"
  • Sinsheim, Germany, 74889
    • "Nycomed Deutschland GmbH"
  • Solingen, Germany, 42651
    • "Nycomed Deutschland GmbH"
  • Sonneberg, Germany, 96515
    • "Nycomed Deutschland GmbH"
  • Stadthagen, Germany, 31655
    • "Nycomed Deutschland GmbH"
  • Starnberg, Germany, 82319
    • "Nycomed Deutschland GmbH"
  • Steißlingen, Germany, 78256
    • "Nycomed Deutschland GmbH"
  • Straelen, Germany, 47638
    • "Nycomed Deutschland GmbH"
  • Stuttgart, Germany, 70178
    • "Nycomed Deutschland GmbH"
  • Stuttgart, Germany, 70327
    • "Nycomed Deutschland GmbH"
  • Stuttgart, Germany, 70372
    • "Nycomed Deutschland GmbH"
  • Teterow, Germany, 17166
    • "Nycomed Deutschland GmbH"
  • Teuchern, Germany, 06682
    • "Nycomed Deutschland GmbH"
  • Uelzen, Germany, 29525
    • "Nycomed Deutschland GmbH"
  • Ulm, Germany, 89073
    • "Nycomed Deutschland GmbH"
  • Umkirch, Germany, 79224
    • "Nycomed Deutschland GmbH"
  • Villingen-Schwenningen, Germany, 78050
    • "Nycomed Deutschland GmbH"
  • Vilshofen, Germany, 94474
    • "Nycomed Deutschland GmbH"
  • Wallertheim, Germany, 55578
    • "Nycomed Deutschland GmbH"
  • Wilhelmshaven, Germany, 26384
    • "Nycomed Deutschland GmbH"
  • Witten, Germany, 58452
    • "Nycomed Deutschland GmbH"
  • Wörrstadt, Germany, 55286
    • "Nycomed Deutschland GmbH"
  • Wörth, Germany, 76744
    • "Nycomed Deutschland GmbH"
  • Würzburg, Germany, 97070
    • "Nycomed Deutschland GmbH"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Outpatients

Description

Main inclusion criteria:

• History of persistent bronchial asthma

Main exclusion criteria:

• Hypersensitive to compounds of Alvesco
• Other criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Artist	Drug: Ciclesonide; This is an observational study. Therefore, the physician decides about dosage according to individual needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
FEV1, symptom score assessment	within 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Handling of the metered-dose inhaler, safety and tolerability	within 3 months

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: January 23, 2008
• First Submitted That Met QC Criteria: January 23, 2008
• First Posted (Estimate): February 6, 2008

Study Record Updates

• Last Update Posted (Estimate): December 5, 2016
• Last Update Submitted That Met QC Criteria: December 2, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Asthma; ciclesonide; Alvesco; inhaled steroids
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Allergic Agents; Ciclesonide
• Other Study ID Numbers: Alves Artist 07/10