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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00785733
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : December 2, 2010
Information provided by:

Brief Summary:
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 or disease
Moderate/Severe Asthma

Study Type : Observational
Actual Enrollment : 1182 participants
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
Study Start Date : November 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Moderate and severe asthma patients stabilized on Symbicort SMART

Primary Outcome Measures :
  1. Asthma Control Questionnaire ACQ [ Time Frame: 5 visits (V1-week 0, V2-week 4, V3-week 8, V4-week 16, V5-week 24) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00785733

Research Site
Alba Iulia, Romania
Research Site
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
Research Site
Vaslui, Romania
Research Site
Zalau, Romania
Sponsors and Collaborators
Study Chair: Cristina Pentiuc AstraZeneca

Responsible Party: Cristina Pentiuc, Medical Science Director, AstraZeneca Identifier: NCT00785733     History of Changes
Other Study ID Numbers: NIS-RRO-SYM-2008/1
First Posted: November 5, 2008    Key Record Dates
Last Update Posted: December 2, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Budesonide, Formoterol Fumarate Drug Combination
Anti-Asthmatic Agents
Respiratory System Agents