Clinical trial NCT00839800: Study to Investigate the Efficacy of Symbicort® SMART.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Symbicort Turbuhaler
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-02-10
Enrollment: 2091
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study
timeFrame: week 52
Secondary outcomes:
measure: Number of Asthma Exacerbations
timeFrame: up to 52 weeks
measure: Morning Peak Expiratory Flow (PEF)
timeFrame: 52-week treatment period
measure: Evening PEF
timeFrame: 2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period
measure: Forced Expiratory Volume in One Second (FEV1)
timeFrame: 4, 12, 24, 36 and 52 weeks after randomization
measure: Use of As-needed Medication
timeFrame: 52-week treatment period
measure: Asthma Symptom Score
timeFrame: 52-week treatment period
measure: Nights With Awakening(s) Due to Asthma Symptoms
timeFrame: 52-week treatment period
measure: The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations
timeFrame: up to 52 weeks
measure: Symptom-free Days (no Symptoms and no Awakenings)
timeFrame: 52-week treatment period
measure: Percentage of As-needed-free Days
timeFrame: 52-week treatment period
measure: Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use)
timeFrame: 52-week treatment period
measure: Asthma Control Questionnaire (ACQ)
timeFrame: 4, 12, 24, 36 and 52 weeks after randomization
Other outcomes:
Locations:
city: Capital Federal
country: Argentina
facility: Research Site
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Research Site
state: Buenos Aires
city: Monte Grande
country: Argentina
facility: Research Site
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Research Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Research Site
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Research Site
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Research Site
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
state: Brasil
city: Belo Horizonte
country: Brazil
facility: Research Site
state: MG
city: Juiz de Fora
country: Brazil
facility: Research Site
state: MG
city: Rio de Janeiro
country: Brazil
facility: Research Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Research Site
state: RS
city: Florianopolis
country: Brazil
facility: Research Site
state: Santa Catarina
city: Santo Andre
country: Brazil
facility: Research Site
state: SP
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Chongqing
country: China
facility: Research Site
city: Guang Zhou
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Qingdao
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Xi An
country: China
facility: Research Site
city: Tres Rios
country: Costa Rica
facility: Research Site
state: Cartago
city: Barrio San Bosco
country: Costa Rica
facility: Research Site
state: San Jose
city: Budapest
country: Hungary
facility: Research Site
city: Cegled
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Deszk
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Szazhalombatta
country: Hungary
facility: Research Site
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Mangalore
country: India
facility: Research Site
state: Karnataka
city: Mysore
country: India
facility: Research Site
state: Karnataka
city: Trivandrum
country: India
facility: Research Site
state: Kerala
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Nagpur
country: India
facility: Research Site
state: Maharashtra
city: Pune
country: India
facility: Research Site
state: Maharashtra
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Coimabatore
country: India
facility: Research Site
state: Tamilnadu
city: Noida
country: India
facility: Research Site
city: Komaki
country: Japan
facility: Research Site
state: Aichi
city: Seto
country: Japan
facility: Research Site
state: Aichi
city: Asahi
country: Japan
facility: Research Site
state: Chiba
city: Matsuyama
country: Japan
facility: Research Site
state: Ehime
city: Kitakyusyu
country: Japan
facility: Research Site
state: Fukuoka
city: Yanagawa
country: Japan
facility: Research Site
state: Fukuoka
city: Isesaki
country: Japan
facility: Research Site
state: Gunma
city: ORA
country: Japan
facility: Research Site
state: Gunma
city: Fukuyama
country: Japan
facility: Research Site
state: Hiroshima
city: Hiroshima-shi
country: Japan
facility: Research Site
state: Hiroshima
city: Asahikawa
country: Japan
facility: Research Site
state: Hokkaido
city: Chitose
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Tomakomai
country: Japan
facility: Research Site
state: Hokkaido
city: AKO
country: Japan
facility: Research Site
state: Hyogo
city: Himeji
country: Japan
facility: Research Site
state: Hyogo
city: Kobe-city
country: Japan
facility: Research Site
state: Hyogo
city: Hitachi
country: Japan
facility: Research Site
state: Ibaraki
city: Naka-gun
country: Japan
facility: Research Site
state: Ibaraki
city: Morioka
country: Japan
facility: Research Site
state: Iwate
city: Sakaide
country: Japan
facility: Research Site
state: Kagawa
city: Kawasaki-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Kawasaki
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Nagaoka
country: Japan
facility: Research Site
state: Niigata
city: Beppu
country: Japan
facility: Research Site
state: Oita
city: Kurashiki
country: Japan
facility: Research Site
state: Okayama
city: Sakai
country: Japan
facility: Research Site
state: Osaka
city: Matsue
country: Japan
facility: Research Site
state: Shimane
city: Utsunomiya
country: Japan
facility: Research Site
state: Tochigi
city: Chuo
country: Japan
facility: Research Site
state: Tokyo
city: Itabashi
country: Japan
facility: Research Site
state: Tokyo
city: Kodaira
country: Japan
facility: Research Site
state: Tokyo
city: Kokubunji
country: Japan
facility: Research Site
state: Tokyo
city: Machida
country: Japan
facility: Research Site
state: Tokyo
city: Nakano-ku
country: Japan
facility: Research Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Research Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Bucheon
country: Korea, Republic of
facility: Research Site
city: Cheongju
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon
country: Korea, Republic of
facility: Research Site
city: Kubang Kerian
country: Malaysia
facility: Research Site
state: Kelantan
city: Kuantan
country: Malaysia
facility: Research Site
state: Pahang
city: Batu Caves
country: Malaysia
facility: Research Site
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Penang
country: Malaysia
facility: Research Site
city: Surco
country: Peru
facility: Research Site
state: Lima
city: Lima
country: Peru
facility: Research Site
city: Lipa City
country: Philippines
facility: Research Site
state: Batangas
city: Davao City
country: Philippines
facility: Research Site
city: Iloilo City
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Bangkoknoi
country: Thailand
facility: Research Site
state: Bangkok
city: Naimuang
country: Thailand
facility: Research Site
state: Nakhonratchasima
city: Hat Yai
country: Thailand
facility: Research Site
state: Songkla
city: Bangkok
country: Thailand
facility: Research Site
city: Khon Kaen
country: Thailand
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Lund
name: Tomas Andersson, MD
role: STUDY_DIRECTOR
affiliation: Mary Mediatrix Medical Center, Lipa City, Philippines
name: Tito Atienza, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.