Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069289
• Other study ID #: D589DC00007
• Status: Completed
• Phase: Phase 3
• First received: February 11, 2010
• Last updated: September 25, 2012
• Start date: January 2010
• Est. completion date: March 2011

Study information

• Verified date: September 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaJapan: Ministry of Health, Labor and WelfareKorea: Food and Drug AdministrationPhilippines: Department of HealthPoland: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: FSI Scientific Center of Expertise of Medical ApplicationRussia: Ministry of Health of the Russian FederationTaiwan: Department of HealthUkraine: State Pharmacological Center - Ministry of HealthVietnam: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1293
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

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

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Budesonide/formoterol (Symbicort Turbuhaler)
2x160/4.5 microgram, inhalation, twice daily, 12 weeks
• Formoterol (Oxis Turbuhaler)
2 X 4.5 microgram, inhalation, twice daily, 12 weeks

Locations

Country	Name	City	State
India	Research Site	Bangalore	Karnataka
India	Research Site	Coimbatore	Tamil Nadu
India	Research Site	Indore	Madhya Pradesh
India	Research Site	Mysore	Karnataka
India	Research Site	Nagpur	Maharashtra
India	Research Site	New Delhi	Delhi
India	Research Site	Trivandrum	Kerala
Japan	Research Site	Akita-shi	Akita
Japan	Research Site	Asahikawa	Hokkaido
Japan	Research Site	Chino-shi	Nagano
Japan	Research Site	Chuo	Tokyo
Japan	Research Site	Fujisawa	Kanagawa
Japan	Research Site	Fukuoka
Japan	Research Site	Gifu
Japan	Research Site	Himeji	Hyogo
Japan	Research Site	Hiroshima-shi	Hiroshima
Japan	Research Site	Hitachi	Ibaraki
Japan	Research Site	Isahaya-shi	Nagasaki
Japan	Research Site	Itabashi-ku	Tokyo
Japan	Research Site	Itami	Hyogo
Japan	Research Site	Izumi-shi	Osaka
Japan	Research Site	Kagoshima-shi	Kagoshima
Japan	Research Site	Kanazawa	Ishikawa
Japan	Research Site	Kawasaki-shi	Kanagawa
Japan	Research Site	Kishiwada	Osaka
Japan	Research Site	Kitakatsushika-gun	Saitama
Japan	Research Site	Kobe	Hyogo
Japan	Research Site	Kochi
Japan	Research Site	Koshigaya-shi	Saitama
Japan	Research Site	Kurashiki-shi	Okayama
Japan	Research Site	Kyoto
Japan	Research Site	Maebashi	Gunma
Japan	Research Site	Matsue	Shimane
Japan	Research Site	Matsumoto	Nagano
Japan	Research Site	Matsusaka-shi	MIE
Japan	Research Site	Meguro	Tokyo
Japan	Research Site	Minato-ku	Tokyo
Japan	Research Site	Moriguchi	Osaka
Japan	Research Site	Nagaoka	Niigata
Japan	Research Site	Nagoya	Aichi
Japan	Research Site	Naka-gun	Ibaragi
Japan	Research Site	Obihiro	Hokkaido
Japan	Research Site	Okayama-shi	Okayama
Japan	Research Site	Okazaki	Aichi
Japan	Research Site	Osaka-shi	Osaka
Japan	Research Site	OTA	Gunma
Japan	Research Site	Saga
Japan	Research Site	Saiki-shi	Oita
Japan	Researche Site	Sakai-shi	Osaka
Japan	Research Site	Sakaide	Kagawa
Japan	Research Site	Sapporo	Hokkaido
Japan	Research Site	Sendai	Miyagi
Japan	Research Site	Setagaya	Tokyo
Japan	Research Site	Seto	Aichi
Japan	Research Site	Shibata	Miyagi
Japan	Research Site	Shinagawa-ku	Tokyo
Japan	Research Site	Suginami-ku	Tokyo
Japan	Research Site	Sumida-ku	Tokyo
Japan	Research Site	Takayama-shi	Gifu
Japan	Research Site	Tomakomai	Hokkaido
Japan	Research Site	Toyota	Aichi
Japan	Research Site	Toyota-shi	Aichi
Japan	Research Site	Tsukuba	Ibaraki
Japan	Research Site	Urasoe-shi	Okinawa
Japan	Research Site	Wakayama
Japan	Research Site	Yanagawa	Fukuoka
Japan	Research Site	Yokohama	Kanagawa
Japan	Research Site	Yokohama-shi	Kanagawa
Japan	Research Site	Yufu-shi	Oita
Japan	Research Site	Zama-shi	Kanagawa
Korea, Republic of	Research Site	Ansan
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Seoul
Philippines	Research Site	Davao City
Philippines	Research Site	Iloilo City
Philippines	Research Site	Lipa City, Batangas
Philippines	Research Site	Olongapo City
Philippines	Research Site	Quezon City
Philippines	Researche Site	San Fernando	Pampanga
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Chodziez
Poland	Research Site	Jaroslaw
Poland	Research Site	Karpacz
Poland	Research Site	Krakow
Poland	Research Site	Lodz
Poland	Research Site	Loma
Poland	Research Site	Lublin
Poland	Research Site	Ostrow Wielkopolski
Poland	Research Site	Pila
Poland	Research Site	Poznan
Poland	Research Site	Ruda Slaska
Poland	Research Site	Slupca
Poland	Research Site	Tczew
Poland	Research Site	Torun
Poland	Research Site	Turek
Poland	Research Site	Wloszczowa
Poland	Research Site	Zabrze
Poland	Research Site	Zawadzkie
Poland	Research Site	Znin
Russian Federation	Research Site	Barnaul	Russia
Russian Federation	Research Site	Ekaterinburg	Russia
Russian Federation	Research Site	Kazan	Russia
Russian Federation	Research Site	Moscow	Russia
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	St.petersburg	Russia
Russian Federation	Research Site	Vladikavkaz
Taiwan	Research Site	Chiayi
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Keelung
Taiwan	Research Site	Taipei
Ukraine	Research Site	Dnipropetrovsk
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Poltava
Ukraine	Research Site	Uzhgorod
Ukraine	Research Site	Vinytsa
Ukraine	Research Site	Zaporozye
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

India,  Japan,  Korea, Republic of,  Philippines,  Poland,  Russian Federation,  Taiwan,  Ukraine,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Before randomization, 0, 4, 8 and 12 weeks after randomization	No
Secondary	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	Before randomization, 0, 4, 8 and 12 weeks after randomization	No
Secondary	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	Before randomization, 0, 4, 8 and 12 weeks after randomization	No
Secondary	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	Before randomization, 0, 4, 8 and 12 weeks after randomization	No
Secondary	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.	Daily during 12-week randomization treatment	No
Secondary	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	Daily during 12-week randomization treatment	No
Secondary	Morning Peak Expiratory Flow(PEF)	The change from Run-in period average to Treatment period average for each treatment group	Daily during run-in period and daily during 12-week randomization treatment	No
Secondary	Evening Peak Expiratory Flow (PEF)	The change from Run-in period average to Treatment period average for each treatment group	Daily during run-in period and daily during 12-week randomization treatment	No
Secondary	Total Number of Day With Exacerbation	Total number of days with COPD exacerbation for each treatment group	Daily during 12-week randomization treatment	No
Secondary	Morning Forced Expiratory Volume in One Second (FEV1)	The change from Run-in period average to Treatment period average for each treatment group	Daily during run-in period and daily during 12-week randomization treatment	No
Secondary	Evening Forced Expiratory Volume in One Second (FEV1)	The change from Run-in period average to Treatment period average for each treatment group	Daily during run-in period and daily during 12-week randomization treatment	No
Secondary	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	Daily during run-in period and daily during 12-week randomization treatment	No
Secondary	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	Daily during run-in period and daily during 12-week randomization treatment	No
Secondary	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	Daily during run-in period and daily during 12-week randomization treatment	No
Secondary	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.	Daily during run-in period and daily during 12-week randomization treatment	No
Secondary	Use of Rescue Medication	The change from Run-in period average to Treatment period average for each treatment group.	Daily during run-in period and daily during 12-week randomization treatment	No
Secondary	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).	Daily during run-in period and daily during 12-week randomization treatment	No