AsthmaATEMNCT01147224
ATEM (Alvesco Non-interventional Study)
An observational study of Asthma and Allergy, run by AstraZeneca at 79 sites in Austria.
Trial summary
The aim of the study is to evaluate the efficacy of Alvesco in patients with persistent asthma including or excluding allergic components over 3 months, especially in the spring season. Alvesco will be inhaled by a metered-dose inhaler. The study will provide further data on safety and tolerability of Alvesco . Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Alvesco
- How many people
- 400 participants
- Where
- 79 sitesAustria
- Study dates
- Mar 2010to Aug 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients
Main Inclusion Criteria:
- Asthma with or without allergic components
Main Exclusion Criteria:
- Hypersensitive to compounds of Alvesco
- Other criteria as defined in the Summary of Product Characteristics, Chapter 4.3
Trial locations and contacts
79 sites in 1 country.
79 sites in 1 country
Austria79 sites
Nycomed Pharma GmbH
Amstetten, 3300
Nycomed Pharma GmbH
Baden, 2500
Nycomed Pharma GmbH
Bludenz, 6700
Nycomed Pharma GmbH
Böhlerwerk, 3333
Nycomed Pharma GmbH
Braunau am Inn, 5280
Nycomed Pharma GmbH
Bregenz, 6900
Nycomed Pharma GmbH
Dornbirn, 6850
Nycomed Pharma GmbH
Enns, 4470
Nycomed Pharma GmbH
Feldbach, 8330
Nycomed Pharma GmbH
Feldkirch, 6800
Nycomed Pharma GmbH
Furth, 3511
Nycomed Pharma GmbH
Gföhl, 3542
Nycomed Pharma GmbH
Gr. Siegharts, 3812
Nycomed Pharma GmbH
Graz, 8010
Nycomed Pharma GmbH
Graz, 8020
Nycomed Pharma GmbH
Graz, 8036
Nycomed Pharma GmbH
Graz, 8042
Nycomed Pharma GmbH
Graz-Gösting, 8051
Nycomed Pharma GmbH
Groß-Gerungs, 3920
Nycomed Pharma GmbH
Guessing, 7540
Nycomed Pharma GmbH
Gunskirchen, 4623
Nycomed Pharma GmbH
Haag, 4680
Nycomed Pharma GmbH
Hall in Tirol, 6060
Nycomed Pharma GmbH
Hallein, 5400
Nycomed Pharma GmbH
Hartberg, 8230
Nycomed Pharma GmbH
Herzogenburg, 3130
Nycomed Pharma GmbH
Innsbruck, 6020
Nycomed Pharma GmbH
Judenburg, 8750
Nycomed Pharma GmbH
Kaltenbach, 6272
Nycomed Pharma GmbH
Kirchdorf and Der Krems, 4560
Nycomed Pharma GmbH
Kitzbühel, 6370
Nycomed Pharma GmbH
Klein-Pöchlam, 3660
Nycomed Pharma GmbH
Landeck, 6500
Nycomed Pharma GmbH
Leibnitz, Styria, 8430
Nycomed Pharma GmbH
Lenzing, 4860
Nycomed Pharma GmbH
Linz, 4020
Nycomed Pharma GmbH
Linz, 4030
Nycomed Pharma GmbH
Linz, 4040
Nycomed Pharma GmbH
Litschau, 3874
Nycomed Pharma GmbH
Mank, 3240
Nycomed Pharma GmbH
Melk, 3390
Nycomed Pharma GmbH
Mittersill, 5730
Nycomed Pharma GmbH
Mödling, 2340
Nycomed Pharma GmbH
Mühldorf, 3622
Nycomed Pharma GmbH
Münster, 6232
Nycomed Pharma GmbH
Neumarkt am Wallersee, 7461
Nycomed Pharma GmbH
Niederkreuzstetten, 2124
Nycomed Pharma GmbH
Pasching, 4061
Nycomed Pharma GmbH
Pinkafeld, 7423
Nycomed Pharma GmbH
Pucking, 4055
Nycomed Pharma GmbH
Saint Johann I. Pg., 5600
Nycomed Pharma GmbH
Salzburg, 5020
Nycomed Pharma GmbH
Sankt Pölten, 3100
Nycomed Pharma GmbH
Schlüsslberg, 4707
Nycomed Pharma GmbH
Schörfling, 4861
Nycomed Pharma GmbH
Schwanenstadt, 4690
Nycomed Pharma GmbH
St.Georgen i.A., 4880
Nycomed Pharma GmbH
Steyr, 4400
Nycomed Pharma GmbH
Strallegg, 8192
Nycomed Pharma GmbH
Sulz, 6832
Nycomed Pharma GmbH
Thalheim bei Wels, 4600
Nycomed Pharma GmbH
Traisen, 3160
Nycomed Pharma GmbH
Traismauer, 3133
Nycomed Pharma GmbH
Vienna, 1010
Nycomed Pharma GmbH
Vienna, 1030
Nycomed Pharma GmbH
Vienna, 1080
Nycomed Pharma GmbH
Vienna, 1090
Nycomed Pharma GmbH
Vienna, 1100
Nycomed Pharma GmbH
Vienna, 1190
Nycomed Pharma GmbH
Vienna, 1210
Nycomed Pharma GmbH
Vienna, 1220
Nycomed Pharma GmbH
Vienna, 1230
Nycomed Pharma GmbH
Voitsberg, 8570
Nycomed Pharma GmbH
Waidhofen/Thaya, 3830
Nycomed Pharma GmbH
Weitra, 3970
Nycomed Pharma GmbH
Wiener Neustadt, 2700
Nycomed Pharma GmbH
Wilhelmsburg, 3150
Nycomed Pharma GmbH
Ysper, 3683
Nycomed Pharma GmbH
Zwettl Stadt, 3910
About this study
Official title: Alvesco for the Therapy of Persistent Asthma With or Without Allergic Component
The aim of the study is to evaluate the efficacy of Alvesco in patients with persistent asthma including or excluding allergic components over 3 months, especially in the spring season. Alvesco will be inhaled by a metered-dose inhaler. The study will provide further data on safety and tolerability of Alvesco .
- Being tested
- Alvesco
- Keywords
- Asthma, Allergy, Ciclesonide, Alvesco, Inhaled steroids
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlvescoDrug
Also called Ciclesonide
This is an observational study. Therefore, the physician decides about dosage according to individual needs.
| Study group | Role | What they receive |
|---|---|---|
| ATEM | A prospective one-arm non-interventional study with asthma patients treated with Alvesco. Receives: Drug: Alvesco |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success with Alvesco
Pre-/ post comparison of FEV1, Quality of life, Patient Questionnaire
Measured: after 3 months
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2011
- Study completionAug 2011
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca AstraZeneca, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147224
- Sponsor's protocol ID
- CL-9709-401-DE
- Acronym
- ATEM
- Status last verified
- Sep 2016
- First submitted
- 17 Jun 2010
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
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
- Alvesco for the Therapy of Persistent Asthma With or Without Allergic Component
- ClinicalTrials.gov ID
- NCT01147224
- Acronym / sponsor ID
- ATEM / CL-9709-401-DE
- Keywords
- Asthma, Allergy, Ciclesonide, Alvesco, Inhaled steroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Jun 2010 (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.
The aim of the study is to evaluate the efficacy of Alvesco in patients with persistent asthma including or excluding allergic components over 3 months, especially in the spring season. Alvesco will be inhaled by a metered-dose inhaler. The study will provide further data on safety and tolerability of Alvesco .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATEM | – | Drug: AlvescoA prospective one-arm non-interventional study with asthma patients treated with Alvesco. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| AlvescoAlso: CiclesonideThis is an observational study. Therefore, the physician decides about dosage according to individual needs. | Drug | ATEM |
Primary outcome
Treatment success with Alvesco
Time frame: after 3 months
Pre-/ post comparison of FEV1, Quality of life, Patient Questionnaire
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: after 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.
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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
79 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 and Allergy, run by AstraZeneca at 79 sites in Austria.
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 79 sites in Austria. 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?
Treatment success with Alvesco (time frame: after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.