Clinical trial NCT01711840: Clinical Experience Investigation of Symbicort Turbuhaler as Maintenance Therapy and Reliever Therapy
Official title: Symbicort Turbuhaler 30/60 Clinical Experience Investigation for Treatment With Symbicort as Maintenance Therapy and as Needed in Response to Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchial Asthma
Keywords: Bronchial asthma
Symbicort Turbuhaler
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-10-22
Enrollment: 2409
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving Symbicort Turbuhaler as maintenance and reliever therapy for the first time due to 'bronchial asthma ',and possibly requiring as-needed inhalations during the observation period

Brief summary: The purpose of the investigation is to confirm the safety of patients receiving Symbicort Turbuhaler as maintenance and reliever therapy ( Symbicort SMART) under the post-marketing actual use.

Detailed description: Symbicort Turbuhaler 30/60 Clinical Experience Investigation for treatment with Symbicort as maintenance therapy and as needed in response to symptoms

Eligibility criteria: Inclusion Criteria:

* Patients receiving Symbicort Turbuhaler as maintenance and reliever therapy for the first time due to 'bronchial asthma ',and possibly requiring as-needed inhalations during the observation period

Primary outcomes:
measure: Adverse event incidence
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research Site
state: D589ll00001
city: Akita
country: Japan
facility: Research Site
state: D589ll00001
city: Aomori
country: Japan
facility: Research Site
state: D589ll00001
city: Chiba
country: Japan
facility: Research Site
state: D589ll00001
city: Ehime
country: Japan
facility: Research Site
state: D589ll00001
city: Fukui
country: Japan
facility: Research Site
state: D589ll00001
city: Fukuoka
country: Japan
facility: Research Site
state: D589ll00001
city: Fukushima
country: Japan
facility: Research Site
state: D589ll00001
city: Gifu
country: Japan
facility: Research Site
state: D589ll00001
city: Gunma
country: Japan
facility: Research Site
state: D589ll00001
city: Hiroshima
country: Japan
facility: Research Site
state: D589ll00001
city: Hokkaido
country: Japan
facility: Research Site
state: D589ll00001
city: Hyogo
country: Japan
facility: Research Site
state: D589ll00001
city: Ibaraki
country: Japan
facility: Research Site
state: D589ll00001
city: Ishikawa
country: Japan
facility: Research Site
state: D589ll00001
city: Iwate
country: Japan
facility: Research Site
state: D589ll00001
city: Kagawa
country: Japan
facility: Research Site
state: D589ll00001
city: Kagoshima
country: Japan
facility: Research Site
state: D589ll00001
city: Kanagawa
country: Japan
facility: Research Site
state: D589ll00001
city: Kochi
country: Japan
facility: Research Site
state: D589ll00001
city: Kumamoto
country: Japan
facility: Research Site
state: D589ll00001
city: Kyoto
country: Japan
facility: Research Site
state: D589ll00001
city: Mie
country: Japan
facility: Research Site
state: D589ll00001
city: Miyagi
country: Japan
facility: Research Site
state: D589ll00001
city: Miyazaki
country: Japan
facility: Research Site
state: D589ll00001
city: Nagano
country: Japan
facility: Research Site
state: D589ll00001
city: Nagasaki
country: Japan
facility: Research Site
state: D589ll00001
city: Nara
country: Japan
facility: Research Site
state: D589ll00001
city: Niigata
country: Japan
facility: Research Site
state: D589ll00001
city: Oita
country: Japan
facility: Research Site
state: D589ll00001
city: Okayama
country: Japan
facility: Research Site
state: D589ll00001
city: Okinawa
country: Japan
facility: Research Site
state: D589ll00001
city: Osaka
country: Japan
facility: Research Site
state: D589ll00001
city: Saga
country: Japan
facility: Research Site
state: D589ll00001
city: Saitama
country: Japan
facility: Research Site
state: D589ll00001
city: Shiga
country: Japan
facility: Research Site
state: D589ll00001
city: Shimane
country: Japan
facility: Research Site
state: D589ll00001
city: Shizuoka
country: Japan
facility: Research Site
state: D589ll00001
city: Tochigi
country: Japan
facility: Research Site
state: D589ll00001
city: Tokushima
country: Japan
facility: Research Site
state: D589ll00001
city: Tokyo
country: Japan
facility: Research Site
state: D589ll00001
city: Tottori
country: Japan
facility: Research Site
state: D589ll00001
city: Toyama
country: Japan
facility: Research Site
state: D589ll00001
city: Wakayama
country: Japan
facility: Research Site
state: D589ll00001
city: Yamagata
country: Japan
facility: Research Site
state: D589ll00001
city: Yamaguchi
country: Japan
facility: Research Site
state: D589ll00001
city: Yamanashi
country: Japan
facility: Research Site
state: D589ll00001
Study officials:
affiliation: AstraZeneca KK
name: Shigeru Yoshida, MD
role: STUDY_DIRECTOR
References: