NIS-observe Treatment Efficacy in Maintaining Symptoms Control in Moderate/Severe Asthma With Symbicort SMART - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00785733

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:	Cohort, 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:

MedlinePlus related topics: Asthma

Drug Information available for: Symbicort

U.S. FDA Resources

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	1182
Study Start Date:	November 2008
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
Research Site
Alba Iulia, Romania
Research Site
Alexandria, Romania
Research Site
Arad, Romania
Research Site
Bacau, Romania
Research Site
Baia Mare, Romania
Research Site
Botosani, Romania
Research Site
Braila, Romania
Research Site
Brasov, Romania
Research Site
Breaza, Romania
Research Site
Bucuresti, Romania
Research Site
Buftea, Romania
Research Site
Calarasi, Romania
Research Site
Campina, Romania
Research Site
Campulung, Romania
Research Site
Cluj Napoca, Romania
Research Site
Constanta, Romania
Research Site
Craiova, Romania
Research Site
Deva, Romania
Research Site
Drobeta Turnu Severin, Romania
Research Site
Giurgiu, Romania
Research Site
Hunedoara, Romania
Research Site
Iasi, Romania
Research Site
Zalau, Romania
Research Site
Miercurea Ciuc, Romania
Research Site
Mizil, Romania
Research Site
Oradea, Romania
Research Site
Palazu Mare, Romania
Research Site
Piatra Neamt, Romania
Research Site
Pitesti, Romania
Research Site
Ploiesti, Romania
Research Site
Resita, Romania
Research Site
Rm. Valcea, Romania
Research Site
Scornicesti, Romania
Research Site
Sf. Gheorghe, Romania
Research Site
Sibiu, Romania
Research Site
Slobozia, Romania
Research Site
Suceava, Romania
Research Site
Targoviste, Romania
Research Site
Targu Mures, Romania
Research Site
Tg. Jiu, Romania
Research Site
Timisoara, Romania
Research Site
Tulcea, Romania
Research Site
Vaslui, Romania
Research Site
Leordeni, Romania

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair:

Cristina Pentiuc

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca ( Cristina Pentiuc, Medical Science Director )
Study ID Numbers:	NIS-RRO-SYM-2008/1
Study First Received:	November 4, 2008
Last Updated:	January 26, 2010
ClinicalTrials.gov Identifier:	NCT00785733 History of Changes
Health Authority:	Romania: National Medicines Agency

Keywords provided by AstraZeneca:

asthma

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Symbicort
Asthma
Anti-Asthmatic Agents
Pharmacologic Actions

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 04, 2010