NCT00608218

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Shorter than P25 for all trials

Geographic Reach
1 country

153 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

December 5, 2016

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

January 23, 2008

Last Update Submit

December 2, 2016

Conditions

Keywords

Asthmaciclesonideinhaled steroidsAlvesco

Outcome Measures

Primary Outcomes (1)

  • FEV1, symptom score assessment

    within 3 months

Secondary Outcomes (1)

  • Handling of the metered-dose inhaler, safety and tolerability

    within 3 months

Study Arms (1)

Artist

Drug: Ciclesonide

Interventions

This is an observational study. Therefore, the physician decides about dosage according to individual needs.

Artist

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients

You may qualify if:

  • History of persistent bronchial asthma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (153)

"Nycomed Deutschland GmbH"

Adendorf, 21365, Germany

Location

"Nycomed Deutschland GmbH"

Arnstadt, 99310, Germany

Location

"Nycomed Deutschland GmbH"

Auerbach, 08209, Germany

Location

"Nycomed Deutschland GmbH"

Augsburg, 86150, Germany

Location

"Nycomed Deutschland GmbH"

Backnang, 71522, Germany

Location

"Nycomed Deutschland GmbH"

Bad Bramstedt, 24576, Germany

Location

"Nycomed Deutschland GmbH"

Bad Kreuznach, 55543, Germany

Location

"Nycomed Deutschland GmbH"

Bad Lippspringe, 33175, Germany

Location

"Nycomed Deutschland GmbH"

Bad Neuenahr-Ahrweiler, 53474, Germany

Location

"Nycomed Deutschland GmbH"

Bad Neustadt an der Saale, 97616, Germany

Location

"Nycomed Deutschland GmbH"

Bad Soden, 65812, Germany

Location

"Nycomed Deutschland GmbH"

Bad Tölz, 83646, Germany

Location

"Nycomed Deutschland GmbH"

Bautzen, 02625, Germany

Location

"Nycomed Deutschland GmbH"

Bergisch Gladbach, 51429, Germany

Location

"Nycomed Deutschland GmbH"

Berlin, 10117, Germany

Location

"Nycomed Deutschland GmbH"

Berlin, 10247, Germany

Location

"Nycomed Deutschland GmbH"

Berlin, 10365, Germany

Location

"Nycomed Deutschland GmbH"

Berlin, 10367, Germany

Location

"Nycomed Deutschland GmbH"

Berlin, 10625, Germany

Location

"Nycomed Deutschland GmbH"

Berlin, 10711, Germany

Location

"Nycomed Deutschland GmbH"

Berlin, 10717, Germany

Location

"Nycomed Deutschland GmbH"

Berlin, 12165, Germany

Location

"Nycomed Deutschland GmbH"

Berlin, 12627, Germany

Location

"Nycomed Deutschland GmbH"

Berlin, 12687, Germany

Location

"Nycomed Deutschland GmbH"

Berlin, 13057, Germany

Location

"Nycomed Deutschland GmbH"

Berlin, 13086, Germany

Location

"Nycomed Deutschland GmbH"

Berlin, 13156, Germany

Location

"Nycomed Deutschland GmbH"

Berlin, 13465, Germany

Location

"Nycomed Deutschland GmbH"

Berlin, 14059, Germany

Location

"Nycomed Deutschland GmbH"

Bietigheim-Bissingen, 74321, Germany

Location

"Nycomed Deutschland GmbH"

Braunschweig, 38100, Germany

Location

"Nycomed Deutschland GmbH"

Braunschweig, 38106, Germany

Location

"Nycomed Deutschland GmbH"

Bredstedt, 25821, Germany

Location

"Nycomed Deutschland GmbH"

Breisach, 79206, Germany

Location

"Nycomed Deutschland GmbH"

Bremen, 28203, Germany

Location

"Nycomed Deutschland GmbH"

Bremen, 28237, Germany

Location

"Nycomed Deutschland GmbH"

Bremerhaven, 27570, Germany

Location

"Nycomed Deutschland GmbH"

Bremerhaven, 27574, Germany

Location

"Nycomed Deutschland GmbH"

Bröckel, 29356, Germany

Location

"Nycomed Deutschland GmbH"

Bruchsal, 76646, Germany

Location

"Nycomed Deutschland GmbH"

Burgwedel, 30938, Germany

Location

"Nycomed Deutschland GmbH"

Castrop-Rauxel, 44579, Germany

Location

"Nycomed Deutschland GmbH"

Coburg, 96450, Germany

Location

"Nycomed Deutschland GmbH"

Cologne, 50679, Germany

Location

"Nycomed Deutschland GmbH"

Cologne, 50999, Germany

Location

"Nycomed Deutschland GmbH"

Cottbus, 03050, Germany

Location

"Nycomed Deutschland GmbH"

Delitzsch, 04509, Germany

Location

"Nycomed Deutschland GmbH"

Dortmund, 44135, Germany

Location

"Nycomed Deutschland GmbH"

Dortmund, 44287, Germany

Location

"Nycomed Deutschland GmbH"

Dresden, 01099, Germany

Location

"Nycomed Deutschland GmbH"

Dresden, 01307, Germany

Location

"Nycomed Deutschland GmbH"

Duisburg, 47051, Germany

Location

"Nycomed Deutschland GmbH"

Düren, 52349, Germany

Location

"Nycomed Deutschland GmbH"

Düsseldorf, 40237, Germany

Location

"Nycomed Deutschland GmbH"

Eisenach, 99817, Germany

Location

"Nycomed Deutschland GmbH"

Erfurt, 99086, Germany

Location

"Nycomed Deutschland GmbH"

Eschwege, 37269, Germany

Location

"Nycomed Deutschland GmbH"

Finsterwalde, 03238, Germany

Location

"Nycomed Deutschland GmbH"

Flensburg, 24937, Germany

Location

"Nycomed Deutschland GmbH"

Frankfurt, 60322, Germany

Location

"Nycomed Deutschland GmbH"

Freising, 85354, Germany

Location

"Nycomed Deutschland GmbH"

Friedrichshafen, 88045, Germany

Location

"Nycomed Deutschland GmbH"

Fürstenwalde, 15517, Germany

Location

"Nycomed Deutschland GmbH"

Garmisch-Partenkirchen, 82467, Germany

Location

"Nycomed Deutschland GmbH"

Gelsenkirchen, 45881, Germany

Location

"Nycomed Deutschland GmbH"

Gotha, 99867, Germany

Location

"Nycomed Deutschland GmbH"

Greiz, 07973, Germany

Location

"Nycomed Deutschland GmbH"

Hagen, 58089, Germany

Location

"Nycomed Deutschland GmbH"

Halle, 06108, Germany

Location

"Nycomed Deutschland GmbH"

Halle, 06114, Germany

Location

"Nycomed Deutschland GmbH"

Hamburg, 20255, Germany

Location

"Nycomed Deutschland GmbH"

Hamburg, 21077, Germany

Location

"Nycomed Deutschland GmbH"

Hamburg, 22587, Germany

Location

"Nycomed Deutschland GmbH"

Hanover, 30159, Germany

Location

"Nycomed Deutschland GmbH"

Hartha, 04746, Germany

Location

"Nycomed Deutschland GmbH"

Haßloch, 67454, Germany

Location

"Nycomed Deutschland GmbH"

Heidelberg, 69115, Germany

Location

"Nycomed Deutschland GmbH"

Heilbronn, 74072, Germany

Location

"Nycomed Deutschland GmbH"

Herne, 44649, Germany

Location

"Nycomed Deutschland GmbH"

Herten, 45699, Germany

Location

"Nycomed Deutschland GmbH"

Hoyerswerda, 02977, Germany

Location

"Nycomed Deutschland GmbH"

Höchstadt an der Aisch, 91315, Germany

Location

"Nycomed Deutschland GmbH"

Husum, 25813, Germany

Location

"Nycomed Deutschland GmbH"

Jettingen, 71131, Germany

Location

"Nycomed Deutschland GmbH"

Karlsruhe, 76227, Germany

Location

"Nycomed Deutschland GmbH"

Kiel, 24106, Germany

Location

"Nycomed Deutschland GmbH"

Kiel, 24148, Germany

Location

"Nycomed Deutschland GmbH"

Koblenz, 56068, Germany

Location

"Nycomed Deutschland GmbH"

Konstanz, 78462, Germany

Location

"Nycomed Deutschland GmbH"

Laatzen, 30880, Germany

Location

"Nycomed Deutschland GmbH"

Leipzig, 04103, Germany

Location

"Nycomed Deutschland GmbH"

Leipzig, 04207, Germany

Location

"Nycomed Deutschland GmbH"

Leipzig, 04275, Germany

Location

"Nycomed Deutschland GmbH"

Leipzig, 04357, Germany

Location

"Nycomed Deutschland GmbH"

Limburg, 65549, Germany

Location

"Nycomed Deutschland GmbH"

Lohfelden, 34253, Germany

Location

"Nycomed Deutschland GmbH"

Mainz, 55122, Germany

Location

"Nycomed Deutschland GmbH"

Mainz, 55129, Germany

Location

"Nycomed Deutschland GmbH"

Mannheim, 68161, Germany

Location

"Nycomed Deutschland GmbH"

Mannheim, 68165, Germany

Location

"Nycomed Deutschland GmbH"

Marburg, 35037, Germany

Location

"Nycomed Deutschland GmbH"

Markkleeberg, 04416, Germany

Location

"Nycomed Deutschland GmbH"

Menden, 58706, Germany

Location

"Nycomed Deutschland GmbH"

Minden, 32423, Germany

Location

"Nycomed Deutschland GmbH"

Moers, 47441, Germany

Location

"Nycomed Deutschland GmbH"

Mühlhausen, 99974, Germany

Location

"Nycomed Deutschland GmbH"

München, 80336, Germany

Location

"Nycomed Deutschland GmbH"

Neu Wulmstorf, 21629, Germany

Location

"Nycomed Deutschland GmbH"

Neubrandenburg, 17034, Germany

Location

"Nycomed Deutschland GmbH"

Neumarkt, 92318, Germany

Location

"Nycomed Deutschland GmbH"

Neuruppin, 16816, Germany

Location

"Nycomed Deutschland GmbH"

Neuss, 41460, Germany

Location

"Nycomed Deutschland GmbH"

Nordhausen, 99734, Germany

Location

"Nycomed Deutschland GmbH"

Oberursel, 61440, Germany

Location

"Nycomed Deutschland GmbH"

Offenburg, 77654, Germany

Location

"Nycomed Deutschland GmbH"

Osnabrück, 49074, Germany

Location

"Nycomed Deutschland GmbH"

Plauen, 08523, Germany

Location

"Nycomed Deutschland GmbH"

Radebeul, 01445, Germany

Location

"Nycomed Deutschland GmbH"

Rendsburg, 24768, Germany

Location

"Nycomed Deutschland GmbH"

Rosengarten, 21224, Germany

Location

"Nycomed Deutschland GmbH"

Rostock, 18109, Germany

Location

"Nycomed Deutschland GmbH"

Saalfeld, 07318, Germany

Location

"Nycomed Deutschland GmbH"

Saarbrücken, 66111, Germany

Location

"Nycomed Deutschland GmbH"

Saarlouis, 66740, Germany

Location

"Nycomed Deutschland GmbH"

Salzgitter, 38226, Germany

Location

"Nycomed Deutschland GmbH"

Schmölln, 04626, Germany

Location

"Nycomed Deutschland GmbH"

Schwalmtal, 41366, Germany

Location

"Nycomed Deutschland GmbH"

Schwarmstedt, 29690, Germany

Location

"Nycomed Deutschland GmbH"

Schwerin, 19057, Germany

Location

"Nycomed Deutschland GmbH"

Siegen, 57072, Germany

Location

"Nycomed Deutschland GmbH"

Sinsheim, 74889, Germany

Location

"Nycomed Deutschland GmbH"

Solingen, 42651, Germany

Location

"Nycomed Deutschland GmbH"

Sonneberg, 96515, Germany

Location

"Nycomed Deutschland GmbH"

Stadthagen, 31655, Germany

Location

"Nycomed Deutschland GmbH"

Starnberg, 82319, Germany

Location

"Nycomed Deutschland GmbH"

Steißlingen, 78256, Germany

Location

"Nycomed Deutschland GmbH"

Straelen, 47638, Germany

Location

"Nycomed Deutschland GmbH"

Stuttgart, 70178, Germany

Location

"Nycomed Deutschland GmbH"

Stuttgart, 70327, Germany

Location

"Nycomed Deutschland GmbH"

Stuttgart, 70372, Germany

Location

"Nycomed Deutschland GmbH"

Teterow, 17166, Germany

Location

"Nycomed Deutschland GmbH"

Teuchern, 06682, Germany

Location

"Nycomed Deutschland GmbH"

Uelzen, 29525, Germany

Location

"Nycomed Deutschland GmbH"

Ulm, 89073, Germany

Location

"Nycomed Deutschland GmbH"

Umkirch, 79224, Germany

Location

"Nycomed Deutschland GmbH"

Villingen-Schwenningen, 78050, Germany

Location

"Nycomed Deutschland GmbH"

Vilshofen, 94474, Germany

Location

"Nycomed Deutschland GmbH"

Wallertheim, 55578, Germany

Location

"Nycomed Deutschland GmbH"

Wilhelmshaven, 26384, Germany

Location

"Nycomed Deutschland GmbH"

Witten, 58452, Germany

Location

"Nycomed Deutschland GmbH"

Wörrstadt, 55286, Germany

Location

"Nycomed Deutschland GmbH"

Wörth, 76744, Germany

Location

"Nycomed Deutschland GmbH"

Würzburg, 97070, Germany

Location

MeSH Terms

Conditions

Asthma

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • AstraZeneca AstraZeneca

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2008

First Posted

February 6, 2008

Study Start

January 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

December 5, 2016

Record last verified: 2016-09

Locations