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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01069289
First received: February 11, 2010
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Budesonide/formoterol (Symbicort Turbuhaler)
Drug: Formoterol (Oxis Turbuhaler)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pre-dose Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Before randomization, 0, 4, 8 and 12 weeks after randomization ] [ Designated as safety issue: No ]
    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) [ Time Frame: Before randomization, 0, 4, 8 and 12 weeks after randomization ] [ Designated as safety issue: No ]
    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) [ Time Frame: Before randomization, 0, 4, 8 and 12 weeks after randomization ] [ Designated as safety issue: No ]
    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) [ Time Frame: Before randomization, 0, 4, 8 and 12 weeks after randomization ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during 12-week randomization treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during 12-week randomization treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ] [ Designated as safety issue: No ]
    The change from Run-in period average to Treatment period average for each treatment group

  • Evening Peak Expiratory Flow (PEF) [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ] [ Designated as safety issue: No ]
    The change from Run-in period average to Treatment period average for each treatment group

  • Total Number of Day With Exacerbation [ Time Frame: Daily during 12-week randomization treatment ] [ Designated as safety issue: No ]
    Total number of days with COPD exacerbation for each treatment group

  • Morning Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ] [ Designated as safety issue: No ]
    The change from Run-in period average to Treatment period average for each treatment group

  • Evening Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ] [ Designated as safety issue: No ]
    The change from Run-in period average to Treatment period average for each treatment group.

  • St George's Respiratory Questionnaire (SGRQ) Total Score [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ] [ Designated as safety issue: No ]
    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).


Enrollment: 1293
Study Start Date: January 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily
Drug: Budesonide/formoterol (Symbicort Turbuhaler)
2x160/4.5 microgram, inhalation, twice daily, 12 weeks
Other Name: Symbicort Turbuhaler
Active Comparator: 2
Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily
Drug: Formoterol (Oxis Turbuhaler)
2 X 4.5 microgram, inhalation, twice daily, 12 weeks
Other Name: Oxis Turbuhaler

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069289

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01069289     History of Changes
Other Study ID Numbers: D589DC00007
Study First Received: February 11, 2010
Results First Received: March 21, 2012
Last Updated: September 25, 2012
Health Authority: India: Drugs Controller General of India
Japan: Ministry of Health, Labor and Welfare
Korea: Food and Drug Administration
Philippines: Department of Health
Poland: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Taiwan: Department of Health
Ukraine: State Pharmacological Center - Ministry of Health
Vietnam: Ministry of Health

Keywords provided by AstraZeneca:
Symbicort
Oxis
Chronic Obstructive Pulmonary Disease
COPD
Efficacy

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014