Study to Investigate the Efficacy of Symbicort SMART.

Condition(s) targeted: Asthma

Intervention: Symbicort Turbuhaler (Drug); Terbutaline Turbuhaler (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Tomas Andersson, MD, Study Director, Affiliation: AstraZeneca R&D Lund
Tito Atienza, M.D., Principal Investigator, Affiliation: Mary Mediatrix Medical Center, Lipa City, Philippines

Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com

The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4. 5μg, one inhalation bid plus as needed) with Symbicort Turbuhaler 160/4. 5μg, one inhalation bid plus terbutaline Turbuhaler 0. 4 mg as needed, as asthma therapy

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary outcome: Asthma exacerbations

Secondary outcome:

Number of asthma exacerbations

Lung function

Asthma control

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of asthma according to 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 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.

AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com

Research Site, BUENOS AIRES, Argentina; Not yet recruiting

Research Site, SANTA FE, Argentina; Not yet recruiting

Research Site, JUIZ DE FORA, Brazil; Not yet recruiting

Research Site, RIO DE JANEIRO, Brazil; Not yet recruiting

Research Site, BELO HORIZONTE, Brazil; Not yet recruiting

Research Site, CURITIBA, Brazil; Not yet recruiting

Research Site, SAO PAULO, Brazil; Not yet recruiting

Research Site, BEIJING, China; Not yet recruiting

Research Site, CHONGQING, China; Not yet recruiting

Research Site, GUANG ZHOU, China; Recruiting

Research Site, NANJING, China; Not yet recruiting

Research Site, QINGDAO, China; Not yet recruiting

Research Site, SHANGHAI, China; Not yet recruiting

Research Site, XI AN, China; Not yet recruiting

Research Site, SAN JOSE, Costa Rica; Recruiting

Research Site, BUDAPEST, Hungary; Recruiting

Research Site, CEGLED, Hungary; Recruiting

Research Site, DEBRECEN, Hungary; Recruiting

Research Site, DESZK, Hungary; Recruiting

Research Site, GYULA, Hungary; Recruiting

Research Site, NYIREGYHAZA, Hungary; Recruiting

Research Site, SZAZHALOMBATTA, Hungary; Recruiting

Research Site, GOA, India; Not yet recruiting

Research Site, NOIDA, India; Recruiting

Research Site, FUKUOKA, Japan; Recruiting

Research Site, KYOTO, Japan; Recruiting

Research Site, NIIGATA, Japan; Not yet recruiting

Research Site, OKAYAMA, Japan; Recruiting

Research Site, TOKYO, Japan; Not yet recruiting

Research Site, AKO, Japan; Not yet recruiting

Research Site, KITAKYUSYU, Japan; Recruiting

Research Site, KAGOSHIMA, Japan; Recruiting

Research Site, KOCHI, Japan; Recruiting

Research Site, OITA, Japan; Recruiting

Research Site, BUCHEON, Korea, Republic of; Recruiting

Research Site, CHEONGJU, Korea, Republic of; Recruiting

Research Site, SEOUL, Korea, Republic of; Recruiting

Research Site, SUWON, Korea, Republic of; Recruiting

Research Site, KUALA LUMPUR, Malaysia; Recruiting

Research Site, PENANG, Malaysia; Recruiting

Research Site, LIMA, Peru; Recruiting

Research Site, DAVAO CITY, Philippines; Recruiting

Research Site, ILOILO CITY, Philippines; Recruiting

Research Site, MANILA, Philippines; Not yet recruiting

Research Site, QUEZON CITY, Philippines; Recruiting

Research Site, MOSCOW, Russian Federation; Recruiting

Research Site, CHIANG MAI, Thailand; Not yet recruiting

Research Site, BANGKOK, Thailand; Not yet recruiting

Research Site, KHON KAEN, Thailand; Recruiting

Research Site, PATUMTHANI, Thailand; Not yet recruiting

Research Site, KOMAKI, AICHI, Japan; Not yet recruiting

Research Site, SETO, AICHI, Japan; Not yet recruiting

Research Site, HYDERABAD, ANDH PRAD, India; Not yet recruiting

Research Site, BANGKOKNOI, BANGKOK, Thailand; Not yet recruiting

Research Site, LIPA CITY, BATANGAS, Philippines; Recruiting

Research Site, PORTO ALEGRE, BRASIL, Brazil; Not yet recruiting

Research Site, CAPITAL FEDERAL, Buenos Aires, Argentina; Not yet recruiting

Research Site, MONTE GRANDE, Buenos Aires, Argentina; Not yet recruiting

Research Site, QUILMES, Buenos Aires, Argentina; Not yet recruiting

Research Site, TRES RIOS, CARTAGO, Costa Rica; Recruiting

Research Site, ASAHI, CHIBA, Japan; Not yet recruiting

Research Site, MATSUYAMA, EHIME, Japan; Not yet recruiting

Research Site, YANAGAWA, FUKUOKA, Japan; Recruiting

Research Site, ISESAKI, GUNMA, Japan; Recruiting

Research Site, ORA, GUNMA, Japan; Recruiting

Research Site, FUKUYAMA, HIROSHIMA, Japan; Recruiting

Research Site, HIROSHIMA CITY, HIROSHIMA, Japan; Recruiting

Research Site, ASAHIKAWA, HOKKAIDO, Japan; Recruiting

Research Site, CHITOSE, HOKKAIDO, Japan; Recruiting

Research Site, SAPPORO, HOKKAIDO, Japan; Recruiting

Research Site, TOMAKOMAI, HOKKAIDO, Japan; Recruiting

Research Site, KOBE-CITY, HYOGO, Japan; Recruiting

Research Site, HIMEJI, HYOGO, Japan; Recruiting

Research Site, HITACHI, IBARAKI, Japan; Not yet recruiting

Research Site, NAKA-GUN, IBARAKI, Japan; Recruiting

Research Site, MORIOKA, IWATE, Japan; Recruiting

Research Site, SAKAIDE, KAGAWA, Japan; Recruiting

Research Site, KAWASAKI, KANAGAWA, Japan; Recruiting

Research Site, YOKOHAMA, KANAGAWA, Japan; Recruiting

Research Site, BANGALORE, KARNATAKA, India; Recruiting

Research Site, MYSORE, KARNATAKA, India; Recruiting

Research Site, KUBANG KERIAN, KELANTAN, Malaysia; Recruiting

Research Site, SHENYANG, LIAONING, China; Not yet recruiting

Research Site, SURCO, LIMA, Peru; Recruiting

Research Site, MUMBAI, MAHARASHTRA, India; Recruiting

Research Site, NAGPUR, MAHARASHTRA, India; Recruiting

Research Site, PUNE, MAHARASHTRA, India; Recruiting

Research Site, SENDAI, MIYAGI, Japan; Not yet recruiting

Research Site, NAGAOKA-CITY, NIIGATA, Japan; Recruiting

Research Site, NAIMUANG, Nakhonratchasima, Thailand; Not yet recruiting

Research Site, BEPPU, OITA, Japan; Recruiting

Research Site, KURASHIKI, OKAYAMA, Japan; Recruiting

Research Site, SAKAI, OSAKA, Japan; Recruiting

Research Site, KUANTAN, PAHANG, Malaysia; Recruiting

Research Site, MAR DEL PLATA, Prov. Buenos Aires, Argentina; Not yet recruiting

Research Site, ROSARIO, SANTA FE, Argentina; Not yet recruiting

Research Site, SANTO ANDRE, SAO PAULO, Brazil; Not yet recruiting

Research Site, BATU CAVES, SELANGOR, Malaysia; Recruiting

Research Site, MATSUE, SHIMANE, Japan; Recruiting

Research Site, HAT YAI, SONGKLA, Thailand; Recruiting

Research Site, FLORIANOPOLIS, Santa Catarina, Brazil; Not yet recruiting

Research Site, COIMABATORE, TAMILNADU, India; Recruiting

Research Site, UTSUNOMIYA, TOCHIGI, Japan; Recruiting

Research Site, ITABASHI, TOKYO, Japan; Not yet recruiting

Research Site, KODAIRA, TOKYO, Japan; Recruiting

Research Site, KOKUBUNJI, TOKYO, Japan; Not yet recruiting

Research Site, MACHIDA, TOKYO, Japan; Recruiting

Research Site, NAKANO-KU, TOKYO, Japan; Recruiting

Research Site, SAN MIGUEL DE TUCUMAN, TUCUMAN, Argentina; Not yet recruiting

Research Site, UBE, YAMAGUCHI, Japan; Not yet recruiting

Research Site, HANGZHOU, ZHEJIANG, China; Not yet recruiting

Starting date: February 2009
Ending date: February 2011
Last updated: August 25, 2009