Study to Investigate the Efficacy of Symbicort® SMART.

Asthma Clinical Trial

— SAKURA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839800
• Other study ID #: D589LC00001
• Status: Completed
• Phase: Phase 3
• First received: February 4, 2009
• Last updated: November 26, 2012
• Start date: February 2009
• Est. completion date: February 2011

Study information

• Verified date: November 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: National Health Surveillance AgencyChina: Ministry of HealthChina: Food and Drug AdministrationCosta Rica: CEC-UCIMEDHungary: National Institute of PharmacyIndia: Drugs Controller General of IndiaJapan: Ministry of Health, Labor and WelfareMalaysia: Ministry of HealthPhilippines: Bureau of Food and DrugsRussia: Ministry of Health of the Russian FederationSouth Korea: Korea Food and Drug Administration (KFDA)Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2091
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Symbicort Turbuhaler
160/4.5 µg
• Terbutaline Turbuhaler
0.4 mg

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Capital Federal	Buenos Aires
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	Mar Del Plata	Buenos Aires
Argentina	Research Site	Monte Grande	Buenos Aires
Argentina	Research Site	Quilmes	Buenos Aires
Argentina	Research Site	Rosario	Santa Fe
Argentina	Research Site	San Miguel de Tucuman	Tucuman
Argentina	Research Site	Santa Fe
Brazil	Research Site	Belo Horizonte	MG
Brazil	Research Site	Florianopolis	Santa Catarina
Brazil	Research Site	Juiz de Fora	MG
Brazil	Research Site	Porto Alegre	Brasil
Brazil	Research Site	Porto Alegre	RS
Brazil	Research Site	Rio de Janeiro	RJ
Brazil	Research Site	Santo Andre	SP
China	Research Site	Chongqing
China	Research Site	Guang Zhou
China	Research Site	Hangzhou	Zhejiang
China	Research Site	Nanjing
China	Research Site	Qingdao
China	Research Site	Shanghai
China	Research Site	Shenyang	Liaoning
China	Research Site	Xi An
Costa Rica	Research Site	Barrio San Bosco	San Jose
Costa Rica	Research Site	Tres Rios	Cartago
Hungary	Research Site	Budapest
Hungary	Research Site	Cegled
Hungary	Research Site	Debrecen
Hungary	Research Site	Deszk
Hungary	Research Site	Gyula
Hungary	Research Site	Nyiregyhaza
Hungary	Research Site	Szazhalombatta
India	Research Site	Bangalore	Karnataka
India	Research Site	Coimabatore	Tamilnadu
India	Research Site	Jaipur	Rajasthan
India	Research Site	Mangalore	Karnataka
India	Research Site	Mumbai	Maharashtra
India	Research Site	Mysore	Karnataka
India	Research Site	Nagpur	Maharashtra
India	Research Site	Noida
India	Research Site	Pune	Maharashtra
India	Research Site	Trivandrum	Kerala
Japan	Research Site	AKO	Hyogo
Japan	Research Site	Asahi	Chiba
Japan	Research Site	Asahikawa	Hokkaido
Japan	Research Site	Beppu	Oita
Japan	Research Site	Chitose	Hokkaido
Japan	Research Site	Chuo	Tokyo
Japan	Research Site	Fukuoka
Japan	Research Site	Fukuyama	Hiroshima
Japan	Research Site	Himeji	Hyogo
Japan	Research Site	Hiroshima-shi	Hiroshima
Japan	Research Site	Hitachi	Ibaraki
Japan	Research Site	Isesaki	Gunma
Japan	Research Site	Itabashi	Tokyo
Japan	Research Site	Kagoshima
Japan	Research Site	Kawasaki	Kanagawa
Japan	Research Site	Kawasaki-shi	Kanagawa
Japan	Research Site	Kitakyusyu	Fukuoka
Japan	Research Site	Kobe-city	Hyogo
Japan	Research Site	Kochi
Japan	Research Site	Kodaira	Tokyo
Japan	Research Site	Kokubunji	Tokyo
Japan	Research Site	Komaki	Aichi
Japan	Research Site	Kurashiki	Okayama
Japan	Research Site	Kyoto
Japan	Research Site	Machida	Tokyo
Japan	Research Site	Matsue	Shimane
Japan	Research Site	Matsuyama	Ehime
Japan	Research Site	Morioka	Iwate
Japan	Research Site	Nagaoka	Niigata
Japan	Research Site	Naka-gun	Ibaraki
Japan	Research Site	Nakano-ku	Tokyo
Japan	Research Site	Niigata
Japan	Research Site	Oita
Japan	Research Site	Okayama
Japan	Research Site	ORA	Gunma
Japan	Research Site	Sakai	Osaka
Japan	Research Site	Sakaide	Kagawa
Japan	Research Site	Sapporo	Hokkaido
Japan	Research Site	Sendai	Miyagi
Japan	Research Site	Seto	Aichi
Japan	Research Site	Tomakomai	Hokkaido
Japan	Research Site	Toshima-ku	Tokyo
Japan	Research Site	Utsunomiya	Tochigi
Japan	Research Site	Yanagawa	Fukuoka
Japan	Research Site	Yokohama	Kanagawa
Korea, Republic of	Research Site	Bucheon
Korea, Republic of	Research Site	Cheongju
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon
Malaysia	Research Site	Batu Caves	Selangor
Malaysia	Research Site	Kuala Lumpur
Malaysia	Research Site	Kuantan	Pahang
Malaysia	Research Site	Kubang Kerian	Kelantan
Malaysia	Research Site	Penang
Peru	Research Site	Lima
Peru	Research Site	Surco	Lima
Philippines	Research Site	Davao City
Philippines	Research Site	Iloilo City
Philippines	Research Site	Lipa City	Batangas
Philippines	Research Site	Manila
Philippines	Research Site	Quezon City
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkoknoi	Bangkok
Thailand	Research Site	Hat Yai	Songkla
Thailand	Research Site	Khon Kaen
Thailand	Research Site	Naimuang	Nakhonratchasima

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Argentina,  Brazil,  China,  Costa Rica,  Hungary,  India,  Japan,  Korea, Republic of,  Malaysia,  Peru,  Philippines,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Asthma Exacerbations	Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here.	up to 52 weeks	No
Secondary	Morning Peak Expiratory Flow (PEF)	The mean value from a 52-week treatment period.	52-week treatment period	No
Secondary	Evening PEF	The mean value from a 52-week treatment period.	2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period	No
Secondary	Forced Expiratory Volume in One Second (FEV1)	The mean value for Weeks 4, 12, 24, 36 and 52 was analysed.	4, 12, 24, 36 and 52 weeks after randomization	No
Secondary	Use of As-needed Medication	The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time).	52-week treatment period	No
Secondary	Asthma Symptom Score	The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst).	52-week treatment period	No
Secondary	Nights With Awakening(s) Due to Asthma Symptoms	The mean value from the treatment period was presented here.	52-week treatment period	No
Secondary	The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations	Mild asthma exacerbation was defined as morning PEF =20% below baseline, daily as-needed medication use =2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here.	up to 52 weeks	No
Secondary	Symptom-free Days (no Symptoms and no Awakenings)	A symptom-free day was defined as a day without daytime or night-time symptoms and without night-time awakenings due to asthma symptoms. The mean value was presented here.	52-week treatment period	No
Secondary	Percentage of As-needed-free Days	An as-needed-free day is defined as a night and day with no use of as-needed medication. The mean value from the treatment period was presented here.	52-week treatment period	No
Secondary	Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use)	An asthma-control day was defined as a a night and day with no asthma symptoms, no awakenings due to asthma symptoms, and no as-needed medication use. The mean value from the treatment period was presented here.	52-week treatment period	No
Secondary	Asthma Control Questionnaire (ACQ)	The ACQ developed by Juniper and colleagues (Juniper et al 1999) was used without the FEV1 and Beta 2-agonist questions. The Asthma Control Questionnaire has 5 questions that are assessed on a 7-point scale from 0 to 6 where 0 represents good control and 6 represents poor control. The overall score is the mean of the five responses. At least 4 out of the 5 questions must have been answered to provide a value. The mean of the overall score for Weeks 4 to 52 was presented here.	4, 12, 24, 36 and 52 weeks after randomization	No