Clinical trial NCT00785733: NIS-observe Treatment Efficacy in Maintaining Symptoms Control in Moderate/Severe Asthma With Symbicort SMART
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate/Severe Asthma
Keywords: asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-05
Enrollment: 1182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The programme will include patients with moderate and severe asthma stabilized on Symbicort SMART from community sample

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


Eligibility 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.

Primary outcomes:
measure: Asthma Control Questionnaire ACQ
timeFrame: 5 visits (V1-week 0, V2-week 4, V3-week 8, V4-week 16, V5-week 24)
Secondary outcomes:
Other outcomes:
Locations:
city: Alba Iulia
country: Romania
facility: Research Site
city: Alexandria
country: Romania
facility: Research Site
city: Arad
country: Romania
facility: Research Site
city: Bacau
country: Romania
facility: Research Site
city: Baia Mare
country: Romania
facility: Research Site
city: Botosani
country: Romania
facility: Research Site
city: Braila
country: Romania
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Breaza
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Buftea
country: Romania
facility: Research Site
city: Calarasi
country: Romania
facility: Research Site
city: Campina
country: Romania
facility: Research Site
city: Campulung
country: Romania
facility: Research Site
city: Cluj Napoca
country: Romania
facility: Research Site
city: Constanta
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Deva
country: Romania
facility: Research Site
city: Drobeta Turnu Severin
country: Romania
facility: Research Site
city: Giurgiu
country: Romania
facility: Research Site
city: Hunedoara
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Leordeni
country: Romania
facility: Research Site
city: Miercurea Ciuc
country: Romania
facility: Research Site
city: Mizil
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Palazu Mare
country: Romania
facility: Research Site
city: Piatra Neamt
country: Romania
facility: Research Site
city: Pitesti
country: Romania
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
city: Resita
country: Romania
facility: Research Site
city: Rm. Valcea
country: Romania
facility: Research Site
city: Scornicesti
country: Romania
facility: Research Site
city: Sf. Gheorghe
country: Romania
facility: Research Site
city: Sibiu
country: Romania
facility: Research Site
city: Slobozia
country: Romania
facility: Research Site
city: Suceava
country: Romania
facility: Research Site
city: Targoviste
country: Romania
facility: Research Site
city: Targu Mures
country: Romania
facility: Research Site
city: Tg. Jiu
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Tulcea
country: Romania
facility: Research Site
city: Vaslui
country: Romania
facility: Research Site
city: Zalau
country: Romania
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Cristina Pentiuc
role: STUDY_CHAIR
References: