AsthmaARTISTNCT00608218

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

An observational study of Asthma, run by AstraZeneca at 153 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Asthma
What is being tested?: Ciclesonide
How many people: 2,100 participants
Where: 153 sitesGermany
Study dates: Jan 2008to Aug 2008
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Outpatients

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)

Trial locations and contacts

153 sites in 1 country.

City, postcode or hospital

153 sites in 1 country

Germany153 sites

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

Other trials in Germany

About this study

Official title: Ciclesonide for the Therapy of Asthma During the Cold Season.

Conditions: Asthma
Being tested: Ciclesonide
Keywords: Asthma, ciclesonide, inhaled steroids, Alvesco
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00608218
Study group	Role	What they receive
Artist		Not described Receives: Drug: Ciclesonide

What is being measured

The primary outcome is the main question the study is designed to answer.

FEV1, symptom score assessment
Measured: within 3 months

Secondary outcomes (1)

Handling of the metered-dose inhaler, safety and tolerability
Measured: within 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Aug 2008

First posted6 Feb 2008 (estimated)
Study startJan 2008
Primary completionAug 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 2,100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00608218
Sponsor's protocol ID: Alves Artist 07/10
Acronym: ARTIST
Status last verified: Sep 2016
First submitted: 23 Jan 2008
Last updated: 5 Dec 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ciclesonide for the Therapy of Asthma During the Cold Season.
ClinicalTrials.gov ID: NCT00608218
Acronym / sponsor ID: ARTIST / Alves Artist 07/10
Conditions: Asthma
Keywords: Asthma, ciclesonide, inhaled steroids, Alvesco
Study type: Observational
Recruitment status: Completed
Enrolment: 2,100 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 6 Feb 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Artist	–	Drug: Ciclesonide

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Outpatients

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CiclesonideThis is an observational study. Therefore, the physician decides about dosage according to individual needs.	Drug	Artist

Primary outcome

FEV1, symptom score assessment
Time frame: within 3 months

1 secondary outcome

Handling of the metered-dose inhaler, safety and tolerability
Time frame: within 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AstraZeneca AstraZeneca study director

AstraZeneca

153 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by AstraZeneca at 153 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FEV1, symptom score assessment (time frame: within 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00608218.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.