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

September 25, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1293

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Oxis Turbuhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-dose Forced Expiratory Volume in One Second (FEV1)
Time Frame: Before randomization, 0, 4, 8 and 12 weeks after randomization
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1)
Time Frame: Before randomization, 0, 4, 8 and 12 weeks after randomization
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
Pre-dose Forced Vital Capacity (FVC)
Time Frame: Before randomization, 0, 4, 8 and 12 weeks after randomization
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
1 Hour Post-dose Forced Vital Capacity (FVC)
Time Frame: Before randomization, 0, 4, 8 and 12 weeks after randomization
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
Percentage of Participants With Exacerbations
Time Frame: Daily during 12-week randomization treatment
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
Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Time Frame: Daily during 12-week randomization treatment
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
Morning Peak Expiratory Flow(PEF)
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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
Evening Peak Expiratory Flow (PEF)
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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
Total Number of Day With Exacerbation
Time Frame: Daily during 12-week randomization treatment
Total number of days with COPD exacerbation for each treatment group
Daily during 12-week randomization treatment
Morning Forced Expiratory Volume in One Second (FEV1)
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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
Evening Forced Expiratory Volume in One Second (FEV1)
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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
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
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
Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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
Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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
Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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
Use of Rescue Medication
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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
St George's Respiratory Questionnaire (SGRQ) Total Score
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

February 11, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (Estimate)

February 17, 2010

Study Record Updates

Last Update Posted (Estimate)

October 25, 2012

Last Update Submitted That Met QC Criteria

September 25, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D589DC00007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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