Clinical trial NCT01069289: Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: A Phase III, 12-week, Double-blind, Randomised, Parallel-group, Active-controlled, Multinational, Efficacy and Safety Study of Symbicort® Turbuhaler® 160/4.5 μg 2 Inhalations Twice Daily (Bid) Compared to Oxis® Turbuhaler® 4.5 μg 2 Inhalations Twice Daily (Bid) in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Symbicort
Oxis
Chronic Obstructive Pulmonary Disease
COPD
Efficacy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 1293
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.


Eligibility criteria: Inclusion Criteria:

* A current clinical diagnosis of Chronic Obstructive Pulmonary Disease
* Documented Chronic Obstructive Pulmonary Disease symptoms for more than 2 years
* A smoking history of at least 10 pack years

Exclusion Criteria:

* History and/or current clinical diagnosis of asthma
* History and/or current clinical diagnosis of atopic diseases such as allergic rhinitis

Primary outcomes:
measure: Pre-dose Forced Expiratory Volume in One Second (FEV1)
timeFrame: Before randomization, 0, 4, 8 and 12 weeks after randomization
Secondary outcomes:
measure: 1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1)
timeFrame: Before randomization, 0, 4, 8 and 12 weeks after randomization
measure: Pre-dose Forced Vital Capacity (FVC)
timeFrame: Before randomization, 0, 4, 8 and 12 weeks after randomization
measure: 1 Hour Post-dose Forced Vital Capacity (FVC)
timeFrame: Before randomization, 0, 4, 8 and 12 weeks after randomization
measure: Percentage of Participants With Exacerbations
timeFrame: Daily during 12-week randomization treatment
measure: Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
timeFrame: Daily during 12-week randomization treatment
measure: Morning Peak Expiratory Flow(PEF)
timeFrame: Daily during run-in period and daily during 12-week randomization treatment
measure: Evening Peak Expiratory Flow (PEF)
timeFrame: Daily during run-in period and daily during 12-week randomization treatment
measure: Total Number of Day With Exacerbation
timeFrame: Daily during 12-week randomization treatment
measure: Morning Forced Expiratory Volume in One Second (FEV1)
timeFrame: Daily during run-in period and daily during 12-week randomization treatment
measure: Evening Forced Expiratory Volume in One Second (FEV1)
timeFrame: Daily during run-in period and daily during 12-week randomization treatment
measure: Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
timeFrame: Daily during run-in period and daily during 12-week randomization treatment
measure: Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
timeFrame: Daily during run-in period and daily during 12-week randomization treatment
measure: Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
timeFrame: Daily during run-in period and daily during 12-week randomization treatment
measure: Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score
timeFrame: Daily during run-in period and daily during 12-week randomization treatment
measure: Use of Rescue Medication
timeFrame: Daily during run-in period and daily during 12-week randomization treatment
measure: St George's Respiratory Questionnaire (SGRQ) Total Score
timeFrame: Daily during run-in period and daily during 12-week randomization treatment
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Research Site
state: Delhi
city: Bangalore
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: Indore
country: India
facility: Research Site
state: Madhya Pradesh
city: Nagpur
country: India
facility: Research Site
state: Maharashtra
city: Coimbatore
country: India
facility: Research Site
state: Tamil Nadu
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Okazaki
country: Japan
facility: Research Site
state: Aichi
city: Seto
country: Japan
facility: Research Site
state: Aichi
city: Toyota-shi
country: Japan
facility: Research Site
state: Aichi
city: Toyota
country: Japan
facility: Research Site
state: Aichi
city: Akita-shi
country: Japan
facility: Research Site
state: Akita
city: Yanagawa
country: Japan
facility: Research Site
state: Fukuoka
city: Takayama-shi
country: Japan
facility: Research Site
state: Gifu
city: Maebashi
country: Japan
facility: Research Site
state: Gunma
city: OTA
country: Japan
facility: Research Site
state: Gunma
city: Hiroshima-shi
country: Japan
facility: Research Site
state: Hiroshima
city: Asahikawa
country: Japan
facility: Research Site
state: Hokkaido
city: Obihiro
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: Himeji
country: Japan
facility: Research Site
state: Hyogo
city: Itami
country: Japan
facility: Research Site
state: Hyogo
city: Kobe
country: Japan
facility: Research Site
state: Hyogo
city: Naka-gun
country: Japan
facility: Research Site
state: Ibaragi
city: Hitachi
country: Japan
facility: Research Site
state: Ibaraki
city: Tsukuba
country: Japan
facility: Research Site
state: Ibaraki
city: Kanazawa
country: Japan
facility: Research Site
state: Ishikawa
city: Sakaide
country: Japan
facility: Research Site
state: Kagawa
city: Kagoshima-shi
country: Japan
facility: Research Site
state: Kagoshima
city: Fujisawa
country: Japan
facility: Research Site
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Zama-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Matsusaka-shi
country: Japan
facility: Research Site
state: MIE
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Shibata
country: Japan
facility: Research Site
state: Miyagi
city: Chino-shi
country: Japan
facility: Research Site
state: Nagano
city: Matsumoto
country: Japan
facility: Research Site
state: Nagano
city: Isahaya-shi
country: Japan
facility: Research Site
state: Nagasaki
city: Nagaoka
country: Japan
facility: Research Site
state: Niigata
city: Saiki-shi
country: Japan
facility: Research Site
state: Oita
city: Yufu-shi
country: Japan
facility: Research Site
state: Oita
city: Kurashiki-shi
country: Japan
facility: Research Site
state: Okayama
city: Okayama-shi
country: Japan
facility: Research Site
state: Okayama
city: Urasoe-shi
country: Japan
facility: Research Site
state: Okinawa
city: Izumi-shi
country: Japan
facility: Research Site
state: Osaka
city: Kishiwada
country: Japan
facility: Research Site
state: Osaka
city: Moriguchi
country: Japan
facility: Research Site
state: Osaka
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Sakai-shi
country: Japan
facility: Researche Site
state: Osaka
city: Kitakatsushika-gun
country: Japan
facility: Research Site
state: Saitama
city: Koshigaya-shi
country: Japan
facility: Research Site
state: Saitama
city: Matsue
country: Japan
facility: Research Site
state: Shimane
city: Chuo
country: Japan
facility: Research Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Research Site
state: Tokyo
city: Meguro
country: Japan
facility: Research Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Research Site
state: Tokyo
city: Setagaya
country: Japan
facility: Research Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Research Site
state: Tokyo
city: Suginami-ku
country: Japan
facility: Research Site
state: Tokyo
city: Sumida-ku
country: Japan
facility: Research Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Saga
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Ansan
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: San Fernando
country: Philippines
facility: Researche Site
state: Pampanga
city: Davao City
country: Philippines
facility: Research Site
city: Iloilo City
country: Philippines
facility: Research Site
city: Lipa City, Batangas
country: Philippines
facility: Research Site
city: Olongapo City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Chodziez
country: Poland
facility: Research Site
city: Jaroslaw
country: Poland
facility: Research Site
city: Karpacz
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Loma
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Ostrow Wielkopolski
country: Poland
facility: Research Site
city: Pila
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Ruda Slaska
country: Poland
facility: Research Site
city: Slupca
country: Poland
facility: Research Site
city: Tczew
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Turek
country: Poland
facility: Research Site
city: Wloszczowa
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Zawadzkie
country: Poland
facility: Research Site
city: Znin
country: Poland
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
state: Russia
city: Ekaterinburg
country: Russian Federation
facility: Research Site
state: Russia
city: Kazan
country: Russian Federation
facility: Research Site
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Russia
city: St.petersburg
country: Russian Federation
facility: Research Site
state: Russia
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Vladikavkaz
country: Russian Federation
facility: Research Site
city: Chiayi
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Keelung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Poltava
country: Ukraine
facility: Research Site
city: Uzhgorod
country: Ukraine
facility: Research Site
city: Vinytsa
country: Ukraine
facility: Research Site
city: Zaporozye
country: Ukraine
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Lund, Sweden
name: Lars-Göran Carlsson, MD
role: STUDY_CHAIR
affiliation: Department of Respiratory medicine, Juntendo University
name: Yoshinosuke Fukuchi, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: