Back to resultsEfficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients (SUMIRE)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Budesonide/formoterol (Symbicort Turbuhaler)
Formoterol (Oxis Turbuhaler)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Symbicort, Oxis, Chronic Obstructive Pulmonary Disease, COPD, Efficacy
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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily
Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily
Outcomes
Primary Outcome Measures
Pre-dose Forced Expiratory Volume in One Second (FEV1)
The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Secondary Outcome Measures
1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1)
The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Pre-dose Forced Vital Capacity (FVC)
The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
1 Hour Post-dose Forced Vital Capacity (FVC)
The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Percentage of Participants With Exacerbations
A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group.
Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 12-week randomization treatment
Morning Peak Expiratory Flow(PEF)
The change from Run-in period average to Treatment period average for each treatment group
Evening Peak Expiratory Flow (PEF)
The change from Run-in period average to Treatment period average for each treatment group
Total Number of Day With Exacerbation
Total number of days with COPD exacerbation for each treatment group
Morning Forced Expiratory Volume in One Second (FEV1)
The change from Run-in period average to Treatment period average for each treatment group
Evening Forced Expiratory Volume in One Second (FEV1)
The change from Run-in period average to Treatment period average for each treatment group
Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Scored 0 to 1 (0 = no awakening and 1 = awakening). The change from Run-in period average to Treatment period average for each treatment group
Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group
Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group
Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score
The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group.
Use of Rescue Medication
The change from Run-in period average to Treatment period average for each treatment group.
St George's Respiratory Questionnaire (SGRQ) Total Score
The change from Run-in period average to Treatment period average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01069289
Brief Title
Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients
Acronym
SUMIRE
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
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Symbicort, Oxis, Chronic Obstructive Pulmonary Disease, COPD, Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1293 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily
Arm Title
2
Arm Type
Active Comparator
Arm Description
Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily
Intervention Type
Drug
Intervention Name(s)
Budesonide/formoterol (Symbicort Turbuhaler)
Other Intervention Name(s)
Symbicort Turbuhaler
Intervention Description
2x160/4.5 microgram, inhalation, twice daily, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Formoterol (Oxis Turbuhaler)
Other Intervention Name(s)
Oxis Turbuhaler
Intervention Description
2 X 4.5 microgram, inhalation, twice daily, 12 weeks
Primary Outcome Measure Information:
Title
Pre-dose Forced Expiratory Volume in One Second (FEV1)
Description
The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Time Frame
Before randomization, 0, 4, 8 and 12 weeks after randomization
Secondary Outcome Measure Information:
Title
1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1)
Description
The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Time Frame
Before randomization, 0, 4, 8 and 12 weeks after randomization
Title
Pre-dose Forced Vital Capacity (FVC)
Description
The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Time Frame
Before randomization, 0, 4, 8 and 12 weeks after randomization
Title
1 Hour Post-dose Forced Vital Capacity (FVC)
Description
The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Time Frame
Before randomization, 0, 4, 8 and 12 weeks after randomization
Title
Percentage of Participants With Exacerbations
Description
A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group.
Time Frame
Daily during 12-week randomization treatment
Title
Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Description
A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 12-week randomization treatment
Time Frame
Daily during 12-week randomization treatment
Title
Morning Peak Expiratory Flow(PEF)
Description
The change from Run-in period average to Treatment period average for each treatment group
Time Frame
Daily during run-in period and daily during 12-week randomization treatment
Title
Evening Peak Expiratory Flow (PEF)
Description
The change from Run-in period average to Treatment period average for each treatment group
Time Frame
Daily during run-in period and daily during 12-week randomization treatment
Title
Total Number of Day With Exacerbation
Description
Total number of days with COPD exacerbation for each treatment group
Time Frame
Daily during 12-week randomization treatment
Title
Morning Forced Expiratory Volume in One Second (FEV1)
Description
The change from Run-in period average to Treatment period average for each treatment group
Time Frame
Daily during run-in period and daily during 12-week randomization treatment
Title
Evening Forced Expiratory Volume in One Second (FEV1)
Description
The change from Run-in period average to Treatment period average for each treatment group
Time Frame
Daily during run-in period and daily during 12-week randomization treatment
Title
Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Description
Scored 0 to 1 (0 = no awakening and 1 = awakening). The change from Run-in period average to Treatment period average for each treatment group
Time Frame
Daily during run-in period and daily during 12-week randomization treatment
Title
Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Description
There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group
Time Frame
Daily during run-in period and daily during 12-week randomization treatment
Title
Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Description
There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group
Time Frame
Daily during run-in period and daily during 12-week randomization treatment
Title
Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score
Description
The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group.
Time Frame
Daily during run-in period and daily during 12-week randomization treatment
Title
Use of Rescue Medication
Description
The change from Run-in period average to Treatment period average for each treatment group.
Time Frame
Daily during run-in period and daily during 12-week randomization treatment
Title
St George's Respiratory Questionnaire (SGRQ) Total Score
Description
The change from Run-in period average to Treatment period average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
Time Frame
Daily during run-in period and daily during 12-week randomization treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars-Göran Carlsson, MD
Organizational Affiliation
AstraZeneca R&D, Lund, Sweden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yoshinosuke Fukuchi, M.D., PhD
Organizational Affiliation
Department of Respiratory medicine, Juntendo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
New Delhi
State/Province
Delhi
Country
India
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Research Site
City
Mysore
State/Province
Karnataka
Country
India
Facility Name
Research Site
City
Trivandrum
State/Province
Kerala
Country
India
Facility Name
Research Site
City
Indore
State/Province
Madhya Pradesh
Country
India
Facility Name
Research Site
City
Nagpur
State/Province
Maharashtra
Country
India
Facility Name
Research Site
City
Coimbatore
State/Province
Tamil Nadu
Country
India
Facility Name
Research Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Okazaki
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Seto
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Toyota-shi
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Toyota
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Akita-shi
State/Province
Akita
Country
Japan
Facility Name
Research Site
City
Yanagawa
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Takayama-shi
State/Province
Gifu
Country
Japan
Facility Name
Research Site
City
Maebashi
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
OTA
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
Hiroshima-shi
State/Province
Hiroshima
Country
Japan
Facility Name
Research Site
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Obihiro
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Tomakomai
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Himeji
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Itami
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Naka-gun
State/Province
Ibaragi
Country
Japan
Facility Name
Research Site
City
Hitachi
State/Province
Ibaraki
Country
Japan
Facility Name
Research Site
City
Tsukuba
State/Province
Ibaraki
Country
Japan
Facility Name
Research Site
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Research Site
City
Sakaide
State/Province
Kagawa
Country
Japan
Facility Name
Research Site
City
Kagoshima-shi
State/Province
Kagoshima
Country
Japan
Facility Name
Research Site
City
Fujisawa
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Kawasaki-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Zama-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Matsusaka-shi
State/Province
MIE
Country
Japan
Facility Name
Research Site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Research Site
City
Shibata
State/Province
Miyagi
Country
Japan
Facility Name
Research Site
City
Chino-shi
State/Province
Nagano
Country
Japan
Facility Name
Research Site
City
Matsumoto
State/Province
Nagano
Country
Japan
Facility Name
Research Site
City
Isahaya-shi
State/Province
Nagasaki
Country
Japan
Facility Name
Research Site
City
Nagaoka
State/Province
Niigata
Country
Japan
Facility Name
Research Site
City
Saiki-shi
State/Province
Oita
Country
Japan
Facility Name
Research Site
City
Yufu-shi
State/Province
Oita
Country
Japan
Facility Name
Research Site
City
Kurashiki-shi
State/Province
Okayama
Country
Japan
Facility Name
Research Site
City
Okayama-shi
State/Province
Okayama
Country
Japan
Facility Name
Research Site
City
Urasoe-shi
State/Province
Okinawa
Country
Japan
Facility Name
Research Site
City
Izumi-shi
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Kishiwada
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Moriguchi
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Osaka-shi
State/Province
Osaka
Country
Japan
Facility Name
Researche Site
City
Sakai-shi
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Kitakatsushika-gun
State/Province
Saitama
Country
Japan
Facility Name
Research Site
City
Koshigaya-shi
State/Province
Saitama
Country
Japan
Facility Name
Research Site
City
Matsue
State/Province
Shimane
Country
Japan
Facility Name
Research Site
City
Chuo
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Itabashi-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Meguro
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Minato-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Setagaya
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Suginami-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Sumida-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Fukuoka
Country
Japan
Facility Name
Research Site
City
Gifu
Country
Japan
Facility Name
Research Site
City
Kochi
Country
Japan
Facility Name
Research Site
City
Kyoto
Country
Japan
Facility Name
Research Site
City
Saga
Country
Japan
Facility Name
Research Site
City
Wakayama
Country
Japan
Facility Name
Research Site
City
Ansan
Country
Korea, Republic of
Facility Name
Research Site
City
Incheon
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Researche Site
City
San Fernando
State/Province
Pampanga
Country
Philippines
Facility Name
Research Site
City
Davao City
Country
Philippines
Facility Name
Research Site
City
Iloilo City
Country
Philippines
Facility Name
Research Site
City
Lipa City, Batangas
Country
Philippines
Facility Name
Research Site
City
Olongapo City
Country
Philippines
Facility Name
Research Site
City
Quezon City
Country
Philippines
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
Country
Poland
Facility Name
Research Site
City
Chodziez
Country
Poland
Facility Name
Research Site
City
Jaroslaw
Country
Poland
Facility Name
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City
Karpacz
Country
Poland
Facility Name
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City
Krakow
Country
Poland
Facility Name
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City
Lodz
Country
Poland
Facility Name
Research Site
City
Loma
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Ostrow Wielkopolski
Country
Poland
Facility Name
Research Site
City
Pila
Country
Poland
Facility Name
Research Site
City
Poznan
Country
Poland
Facility Name
Research Site
City
Ruda Slaska
Country
Poland
Facility Name
Research Site
City
Slupca
Country
Poland
Facility Name
Research Site
City
Tczew
Country
Poland
Facility Name
Research Site
City
Torun
Country
Poland
Facility Name
Research Site
City
Turek
Country
Poland
Facility Name
Research Site
City
Wloszczowa
Country
Poland
Facility Name
Research Site
City
Zabrze
Country
Poland
Facility Name
Research Site
City
Zawadzkie
Country
Poland
Facility Name
Research Site
City
Znin
Country
Poland
Facility Name
Research Site
City
Barnaul
State/Province
Russia
Country
Russian Federation
Facility Name
Research Site
City
Ekaterinburg
State/Province
Russia
Country
Russian Federation
Facility Name
Research Site
City
Kazan
State/Province
Russia
Country
Russian Federation
Facility Name
Research Site
City
Moscow
State/Province
Russia
Country
Russian Federation
Facility Name
Research Site
City
St.petersburg
State/Province
Russia
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
Country
Russian Federation
Facility Name
Research Site
City
Vladikavkaz
Country
Russian Federation
Facility Name
Research Site
City
Chiayi
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
Country
Taiwan
Facility Name
Research Site
City
Keelung
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Research Site
City
Donetsk
Country
Ukraine
Facility Name
Research Site
City
Kyiv
Country
Ukraine
Facility Name
Research Site
City
Poltava
Country
Ukraine
Facility Name
Research Site
City
Uzhgorod
Country
Ukraine
Facility Name
Research Site
City
Vinytsa
Country
Ukraine
Facility Name
Research Site
City
Zaporozye
Country
Ukraine
Facility Name
Research Site
City
Hanoi
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
Country
Vietnam
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients
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