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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1293

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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