NIS-observe Treatment Efficacy in Maintaining Symptoms Control in Moderate/Severe Asthma With Symbicort SMART
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00785733
First received: November 4, 2008
Last updated: November 30, 2010
Last verified: November 2010
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Purpose
The primary objective of this non-interventional study is to evaluate efficacy of Symbicort® SMART treatment in adult patients with moderate to severe asthma using ACQ scores during 6 months period
| Condition |
|---|
|
Moderate/Severe Asthma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | SMART Way of Treating Asthma. Non-interventional Study to Evaluate Clinical Efficacy of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Patients With Moderate and Severe Asthma |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Asthma Control Questionnaire ACQ [ Time Frame: 5 visits (V1-week 0, V2-week 4, V3-week 8, V4-week 16, V5-week 24) ] [ Designated as safety issue: No ]
| Enrollment: | 1182 |
| Study Start Date: | November 2008 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Moderate and severe asthma patients stabilized on Symbicort SMART
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
The programme will include patients with moderate and severe asthma stabilized on Symbicort SMART from community sample
Criteria
Inclusion Criteria:
- patients eligible for entry into study are the patients diagnosed with moderate to severe asthma, that the doctors have already decided to treat with Symbicort SMART within the last month, before inclusion in this program
- All eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme.
Exclusion Criteria:
- All the patients who have a known hypersensitivity to Symbicort or any of its excipients will not be included in this study.
- As per valid Romanian SmPC, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785733
Locations
| Romania | |
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| Alba Iulia, Romania | |
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| Alexandria, Romania | |
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| Arad, Romania | |
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| Bacau, Romania | |
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| Baia Mare, Romania | |
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| Botosani, Romania | |
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| Braila, Romania | |
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| Brasov, Romania | |
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| Breaza, Romania | |
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| Bucuresti, Romania | |
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| Buftea, Romania | |
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| Calarasi, Romania | |
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| Campina, Romania | |
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| Campulung, Romania | |
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| Cluj Napoca, Romania | |
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| Constanta, Romania | |
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| Craiova, Romania | |
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| Deva, Romania | |
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| Drobeta Turnu Severin, Romania | |
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| Giurgiu, Romania | |
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| Hunedoara, Romania | |
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| Iasi, Romania | |
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| Leordeni, Romania | |
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| Miercurea Ciuc, Romania | |
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| Mizil, Romania | |
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| Oradea, Romania | |
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| Palazu Mare, Romania | |
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| Piatra Neamt, Romania | |
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| Pitesti, Romania | |
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| Ploiesti, Romania | |
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| Resita, Romania | |
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| Rm. Valcea, Romania | |
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| Scornicesti, Romania | |
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| Sf. Gheorghe, Romania | |
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| Sibiu, Romania | |
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| Slobozia, Romania | |
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| Suceava, Romania | |
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| Targoviste, Romania | |
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| Targu Mures, Romania | |
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| Tg. Jiu, Romania | |
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| Timisoara, Romania | |
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| Tulcea, Romania | |
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| Vaslui, Romania | |
| Research Site | |
| Zalau, Romania | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Chair: | Cristina Pentiuc | AstraZeneca |
More Information
No publications provided
| Responsible Party: | Cristina Pentiuc, Medical Science Director, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00785733 History of Changes |
| Other Study ID Numbers: | NIS-RRO-SYM-2008/1 |
| Study First Received: | November 4, 2008 |
| Last Updated: | November 30, 2010 |
| Health Authority: | Romania: National Medicines Agency |
Keywords provided by AstraZeneca:
|
asthma |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Symbicort Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013