Study to Investigate the Efficacy of Symbicort® SMART.
SAKURA
A Comparison of Symbicort® SMART (160/4.5μg) and Symbicort® Turbuhaler 160/4.5 μg, Plus Terbutaline Turbuhaler 0.4 mg as Needed, for Treatment of Asthma - a 12-month, Randomized, Double-blind, Parallel Group, Active-controlled, Multinational Phase III Study in Asthmatic Patients From 16 Years
1 other identifier
interventional
2,091
12 countries
109
Brief Summary
The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Feb 2009
Typical duration for phase_3 asthma
109 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 4, 2009
CompletedFirst Posted
Study publicly available on registry
February 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
November 30, 2012
CompletedNovember 30, 2012
November 1, 2012
2 years
February 4, 2009
February 21, 2012
November 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study
Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid \[GCS\] treatment, hospitalization, or emergency room \[ER\] treatment.
week 52
Secondary Outcomes (12)
Number of Asthma Exacerbations
up to 52 weeks
Morning Peak Expiratory Flow (PEF)
52-week treatment period
Evening PEF
2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period
Forced Expiratory Volume in One Second (FEV1)
4, 12, 24, 36 and 52 weeks after randomization
Use of As-needed Medication
52-week treatment period
- +7 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALSymbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed
2
ACTIVE COMPARATORSymbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of asthma according to the Global Initiative for Asthma guidelines (GINA) 2007 with a documented history of at least 6 months duration.
- Reversible airway obstruction, defined as an increase in FEV1 ≥12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline Turbuhaler
- Prescribed use of inhaled glucocorticoid steroid (GCS) (any brand) for at least 12 weeks.
You may not qualify if:
- Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks.
- Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (109)
Research Site
Buenos Aires, Argentina, Argentina
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Capital Federal, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Monte Grande, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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Santa Fe, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Ciudad de Buenos Aires, Argentina
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Porto Alegre, Brasil, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Juiz de Fora, Minas Gerais, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Florianópolis, Santa Catarina, Brazil
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Santo André, São Paulo, Brazil
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Shenyang, Liaoning, China
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Hangzhou, Zhejiang, China
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Chongqing, China
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Guangzhou, China
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Nanjing, China
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Qingdao, China
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Shanghai, China
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Xi'an, China
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Tres Ríos, Cartago Province, Costa Rica
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Barrio San Bosco, Provincia de San José, Costa Rica
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Budapest, Hungary
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Cegléd, Hungary
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Debrecen, Hungary
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Deszk, Hungary
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Gyula, Hungary
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Nyíregyháza, Hungary
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Százhalombatta, Hungary
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Bangalore, Karnataka, India
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Mangalore, Karnataka, India
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Mysore, Karnataka, India
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Trivandrum, Kerala, India
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Mumbai, Maharashtra, India
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Nagpur, Maharashtra, India
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Pune, Maharashtra, India
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Jaipur, Rajasthan, India
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Coimabatore, Tamil Nadu, India
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Noida, India
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Komaki, Aichi-ken, Japan
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Seto, Aichi-ken, Japan
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Asahi, Chiba, Japan
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Matsuyama, Ehime, Japan
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Fukuoka, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Yanagawa, Fukuoka, Japan
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Isesaki, Gunma, Japan
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Ōwa, Gunma, Japan
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Fukuyama, Hiroshima, Japan
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Hiroshima, Hiroshima, Japan
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Asahikawa, Hokkaido, Japan
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Chitose, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Tomakomai, Hokkaido, Japan
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Ako, Hyōgo, Japan
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Himeji, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Hitachi, Ibaraki, Japan
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Naka-gun, Ibaraki, Japan
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Morioka, Iwate, Japan
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Sakaidechō, Kagawa-ken, Japan
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Kagoshima, Kagoshima-ken, Japan
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Kawasaki, Kanagawa, Japan
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Kawasaki-shi, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Kochi, Kochi, Japan
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Kyoto, Kyoto, Japan
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Sendai, Miyagi, Japan
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Nagaoka, Niigata, Japan
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Niigata, Niigata, Japan
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Beppu, Oita Prefecture, Japan
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Ōita, Oita Prefecture, Japan
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Kurashiki, Okayama-ken, Japan
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Okayama, Okayama-ken, Japan
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Sakai, Osaka, Japan
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Matsue, Shimane, Japan
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Utsunomiya, Tochigi, Japan
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Chūō, Tokyo, Japan
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Kodaira, Tokyo, Japan
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Kokubunji, Tokyo, Japan
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Machida, Tokyo, Japan
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Nakano-ku, Tokyo, Japan
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tabashi City, Tokyo, Japan
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Toshima-ku, Tokyo, Japan
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Kubang Kerian, Kelantan, Malaysia
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Kuantan, Pahang, Malaysia
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Batu Caves, Selangor, Malaysia
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George Town, Malaysia
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Kuala Lumpur, Malaysia
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Lima, Lima Province, Peru
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Surco, Lima region, Peru
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Lipa City, Batangas, Philippines
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Davao City, Philippines, Philippines
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Iloilo City, Philippines
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Manila, Philippines
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Quezon City, Philippines
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Bucheon-si, South Korea
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Cheongju-si, South Korea
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Seoul, South Korea
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Suwon, South Korea
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Bangkoknoi, Bangkok, Thailand
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Hat Yai, Changwat Songkhla, Thailand
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Naimuang, Nakhonratchasima, Thailand
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Bangkok, Thailand, Thailand
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Khon Kaen, Thailand
Related Publications (1)
Zhang O, Minku LL, Gonem S. Detecting asthma exacerbations using daily home monitoring and machine learning. J Asthma. 2021 Nov;58(11):1518-1527. doi: 10.1080/02770903.2020.1802746. Epub 2020 Aug 14.
PMID: 32718193DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Tomas Andersson, MD
AstraZeneca R&D Lund
- PRINCIPAL INVESTIGATOR
Tito Atienza, M.D.
Mary Mediatrix Medical Center, Lipa City, Philippines
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2009
First Posted
February 10, 2009
Study Start
February 1, 2009
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
November 30, 2012
Results First Posted
November 30, 2012
Record last verified: 2012-11