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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01069289
Collaborator
(none)
1,293
Enrollment
120
Locations
2
Arms
13.9
Duration (Months)
10.8
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Budesonide/formoterol (Symbicort Turbuhaler)
  • Drug: Formoterol (Oxis Turbuhaler)
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1293 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Mar 1, 2011
Actual Study Completion Date :
Mar 1, 2011

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pre-dose Forced Expiratory Volume in One Second (FEV1) [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

    Secondary Outcome Measures

    1. 1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1) [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

    2. Pre-dose Forced Vital Capacity (FVC) [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

    3. 1 Hour Post-dose Forced Vital Capacity (FVC) [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

    4. Percentage of Participants With Exacerbations [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.

    5. Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation [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

    6. Morning Peak Expiratory Flow(PEF) [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

    7. Evening Peak Expiratory Flow (PEF) [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

    8. Total Number of Day With Exacerbation [Daily during 12-week randomization treatment]

      Total number of days with COPD exacerbation for each treatment group

    9. Morning Forced Expiratory Volume in One Second (FEV1) [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

    10. Evening Forced Expiratory Volume in One Second (FEV1) [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

    11. Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms [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

    12. Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms [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

    13. Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms [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

    14. Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score [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.

    15. Use of Rescue Medication [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.

    16. St George's Respiratory Questionnaire (SGRQ) Total Score [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Research Site New Delhi Delhi India
    2 Research Site Bangalore Karnataka India
    3 Research Site Mysore Karnataka India
    4 Research Site Trivandrum Kerala India
    5 Research Site Indore Madhya Pradesh India
    6 Research Site Nagpur Maharashtra India
    7 Research Site Coimbatore Tamil Nadu India
    8 Research Site Nagoya Aichi Japan
    9 Research Site Okazaki Aichi Japan
    10 Research Site Seto Aichi Japan
    11 Research Site Toyota-shi Aichi Japan
    12 Research Site Toyota Aichi Japan
    13 Research Site Akita-shi Akita Japan
    14 Research Site Yanagawa Fukuoka Japan
    15 Research Site Takayama-shi Gifu Japan
    16 Research Site Maebashi Gunma Japan
    17 Research Site OTA Gunma Japan
    18 Research Site Hiroshima-shi Hiroshima Japan
    19 Research Site Asahikawa Hokkaido Japan
    20 Research Site Obihiro Hokkaido Japan
    21 Research Site Sapporo Hokkaido Japan
    22 Research Site Tomakomai Hokkaido Japan
    23 Research Site Himeji Hyogo Japan
    24 Research Site Itami Hyogo Japan
    25 Research Site Kobe Hyogo Japan
    26 Research Site Naka-gun Ibaragi Japan
    27 Research Site Hitachi Ibaraki Japan
    28 Research Site Tsukuba Ibaraki Japan
    29 Research Site Kanazawa Ishikawa Japan
    30 Research Site Sakaide Kagawa Japan
    31 Research Site Kagoshima-shi Kagoshima Japan
    32 Research Site Fujisawa Kanagawa Japan
    33 Research Site Kawasaki-shi Kanagawa Japan
    34 Research Site Yokohama-shi Kanagawa Japan
    35 Research Site Yokohama Kanagawa Japan
    36 Research Site Zama-shi Kanagawa Japan
    37 Research Site Matsusaka-shi MIE Japan
    38 Research Site Sendai Miyagi Japan
    39 Research Site Shibata Miyagi Japan
    40 Research Site Chino-shi Nagano Japan
    41 Research Site Matsumoto Nagano Japan
    42 Research Site Isahaya-shi Nagasaki Japan
    43 Research Site Nagaoka Niigata Japan
    44 Research Site Saiki-shi Oita Japan
    45 Research Site Yufu-shi Oita Japan
    46 Research Site Kurashiki-shi Okayama Japan
    47 Research Site Okayama-shi Okayama Japan
    48 Research Site Urasoe-shi Okinawa Japan
    49 Research Site Izumi-shi Osaka Japan
    50 Research Site Kishiwada Osaka Japan
    51 Research Site Moriguchi Osaka Japan
    52 Research Site Osaka-shi Osaka Japan
    53 Researche Site Sakai-shi Osaka Japan
    54 Research Site Kitakatsushika-gun Saitama Japan
    55 Research Site Koshigaya-shi Saitama Japan
    56 Research Site Matsue Shimane Japan
    57 Research Site Chuo Tokyo Japan
    58 Research Site Itabashi-ku Tokyo Japan
    59 Research Site Meguro Tokyo Japan
    60 Research Site Minato-ku Tokyo Japan
    61 Research Site Setagaya Tokyo Japan
    62 Research Site Shinagawa-ku Tokyo Japan
    63 Research Site Suginami-ku Tokyo Japan
    64 Research Site Sumida-ku Tokyo Japan
    65 Research Site Fukuoka Japan
    66 Research Site Gifu Japan
    67 Research Site Kochi Japan
    68 Research Site Kyoto Japan
    69 Research Site Saga Japan
    70 Research Site Wakayama Japan
    71 Research Site Ansan Korea, Republic of
    72 Research Site Incheon Korea, Republic of
    73 Research Site Seoul Korea, Republic of
    74 Researche Site San Fernando Pampanga Philippines
    75 Research Site Davao City Philippines
    76 Research Site Iloilo City Philippines
    77 Research Site Lipa City, Batangas Philippines
    78 Research Site Olongapo City Philippines
    79 Research Site Quezon City Philippines
    80 Research Site Bialystok Poland
    81 Research Site Bydgoszcz Poland
    82 Research Site Chodziez Poland
    83 Research Site Jaroslaw Poland
    84 Research Site Karpacz Poland
    85 Research Site Krakow Poland
    86 Research Site Lodz Poland
    87 Research Site Loma Poland
    88 Research Site Lublin Poland
    89 Research Site Ostrow Wielkopolski Poland
    90 Research Site Pila Poland
    91 Research Site Poznan Poland
    92 Research Site Ruda Slaska Poland
    93 Research Site Slupca Poland
    94 Research Site Tczew Poland
    95 Research Site Torun Poland
    96 Research Site Turek Poland
    97 Research Site Wloszczowa Poland
    98 Research Site Zabrze Poland
    99 Research Site Zawadzkie Poland
    100 Research Site Znin Poland
    101 Research Site Barnaul Russia Russian Federation
    102 Research Site Ekaterinburg Russia Russian Federation
    103 Research Site Kazan Russia Russian Federation
    104 Research Site Moscow Russia Russian Federation
    105 Research Site St.petersburg Russia Russian Federation
    106 Research Site Novosibirsk Russian Federation
    107 Research Site Vladikavkaz Russian Federation
    108 Research Site Chiayi Taiwan
    109 Research Site Kaohsiung Taiwan
    110 Research Site Keelung Taiwan
    111 Research Site Taipei Taiwan
    112 Research Site Dnipropetrovsk Ukraine
    113 Research Site Donetsk Ukraine
    114 Research Site Kyiv Ukraine
    115 Research Site Poltava Ukraine
    116 Research Site Uzhgorod Ukraine
    117 Research Site Vinytsa Ukraine
    118 Research Site Zaporozye Ukraine
    119 Research Site Hanoi Vietnam
    120 Research Site 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT01069289
    Other Study ID Numbers:
    • D589DC00007
    First Posted:
    Feb 17, 2010
    Last Update Posted:
    Oct 25, 2012
    Last Verified:
    Sep 1, 2012
    Keywords provided by AstraZeneca
    Symbicort
    Oxis
    Chronic Obstructive Pulmonary Disease
    COPD
    Efficacy
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive
    Budesonide
    Formoterol Fumarate
    Budesonide, Formoterol Fumarate Drug Combination

    Study Results

    Participant Flow

    Recruitment Details The first participant entered the study on 28 January 2010, and the last participant completed the study on 30 March 2011. A total of 1,710 participants were enrolled at 163 centres in 9 countries in Asia and Europe, and 1,293 participants who fulfilled the randomisation criteria were randomised.
    Pre-assignment Detail The study started with an enrolment visit, Visit 1, 0 to 4 weeks prior to Visit 2, and 1-2 week run-in period before randomization. At Visit 2 participants had to have pre-bronchodilatory forced expiratory volume in one second (FEV1) less than or equal to 50 percent of the predicted normal value.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Period Title: Overall Study
    STARTED 636 657
    COMPLETED 594 601
    NOT COMPLETED 42 56

    Baseline Characteristics

    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator) Total
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid) Total of all reporting groups
    Overall Participants 636 657 1293
    Age (Years) [Mean (Full Range) ]
    Mean (Full Range) [Years]
    64.5
    65.6
    65.1
    Sex: Female, Male (Count of Participants)
    Female
    79
    12.4%
    64
    9.7%
    143
    11.1%
    Male
    557
    87.6%
    593
    90.3%
    1150
    88.9%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Measure Participants 618 635
    Geometric Mean (Full Range) [percentage of Baseline]
    104.6
    101.5
    2. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Measure Participants 635 657
    Geometric Mean (Full Range) [percentage of Baseline]
    113.9
    111.2
    3. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Measure Participants 618 635
    Geometric Mean (Full Range) [percentage of Baseline]
    102.2
    100.9
    4. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis set for efficacy was based on the Full Analysis Set (FAS. Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Measure Participants 635 657
    Geometric Mean (Full Range) [percentage of Baseline]
    110.1
    108.7
    5. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis set for efficacy was based on the Full Analysis Set (FAS).Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Measure Participants 636 657
    Number [percentage of participants]
    11.9
    1.9%
    16.9
    2.6%
    6. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Measure Participants 636 657
    Number [event]
    93
    151
    7. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Measure Participants 613 637
    Mean (Standard Deviation) [Liter/minute (L/min)]
    4.29
    (36.58)
    -4.78
    (30.61)
    8. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Measure Participants 612 637
    Mean (Standard Deviation) [Liter/minute (L/min)]
    2.55
    (36.57)
    -5.13
    (31.52)
    9. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Measure Participants 636 657
    Number [days]
    653
    1098
    10. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Measure Participants 613 637
    Mean (Standard Deviation) [Liter (L)]
    0.0244
    (0.2136)
    -0.0312
    (0.1712)
    11. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Measure Participants 612 637
    Mean (Standard Deviation) [Liter (L)]
    0.0176
    (0.2268)
    -0.0324
    (0.1724)
    12. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Measure Participants 628 647
    Mean (Standard Deviation) [Nights with symptoms]
    -0.20
    (0.67)
    -0.15
    (0.66)
    13. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Measure Participants 628 647
    Mean (Standard Deviation) [units on a scale]
    -0.34
    (0.66)
    -0.23
    (0.65)
    14. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Measure Participants 628 647
    Mean (Standard Deviation) [units on a scale]
    -0.24
    (0.70)
    -0.24
    (0.68)
    15. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Measure Participants 628 647
    Mean (Standard Deviation) [units on a scale]
    -0.78
    (1.62)
    -0.61
    (1.56)
    16. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Measure Participants 628 647
    Mean (Standard Deviation) [inhalations/day]
    -0.51
    (1.51)
    -0.26
    (1.49)
    17. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    Measure Participants 621 634
    Mean (Standard Deviation) [units on a scale]
    -4.37
    (14.544)
    -2.90
    (13.783)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
    All Cause Mortality
    Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 43/636 (6.8%) 45/657 (6.8%)
    Cardiac disorders
    ACUTE MYOCARDIAL INFARCTION 0/636 (0%) 1/657 (0.2%)
    ANGINA PECTORIS 0/636 (0%) 1/657 (0.2%)
    ANGINA UNSTABLE 0/636 (0%) 1/657 (0.2%)
    CARDIAC FAILURE 1/636 (0.2%) 0/657 (0%)
    CARDIAC FAILURE CHRONIC 1/636 (0.2%) 0/657 (0%)
    CARDIOVASCULAR INSUFFICIENCY 1/636 (0.2%) 0/657 (0%)
    CORONARY ARTERY INSUFFICIENCY 0/636 (0%) 1/657 (0.2%)
    MYOCARDIAL ISCHAEMIA 0/636 (0%) 1/657 (0.2%)
    Eye disorders
    AMAUROSIS FUGAX 1/636 (0.2%) 0/657 (0%)
    CATARACT 1/636 (0.2%) 0/657 (0%)
    Gastrointestinal disorders
    ABDOMINAL PAIN 0/636 (0%) 1/657 (0.2%)
    COLITIS ISCHAEMIC 0/636 (0%) 1/657 (0.2%)
    DIVERTICULUM INTESTINAL HAEMORRHAGIC 0/636 (0%) 1/657 (0.2%)
    ILEUS 1/636 (0.2%) 0/657 (0%)
    PANCREATIC MASS 0/636 (0%) 1/657 (0.2%)
    PERITONITIS 1/636 (0.2%) 0/657 (0%)
    General disorders
    DEATH 1/636 (0.2%) 0/657 (0%)
    Hepatobiliary disorders
    CHOLECYSTITIS ACUTE 1/636 (0.2%) 0/657 (0%)
    Infections and infestations
    APPENDICITIS 2/636 (0.3%) 0/657 (0%)
    PNEUMONIA BACTERIAL 1/636 (0.2%) 1/657 (0.2%)
    BRONCHITIS 0/636 (0%) 1/657 (0.2%)
    BRONCHOPNEUMONIA 1/636 (0.2%) 0/657 (0%)
    POSTOPERATIVE ABSCESS 1/636 (0.2%) 0/657 (0%)
    Investigations
    COMPUTERISED TOMOGRAM THORAX ABNORMAL 1/636 (0.2%) 0/657 (0%)
    Metabolism and nutrition disorders
    HYPOGLYCAEMIA 0/636 (0%) 1/657 (0.2%)
    HYPOKALAEMIA 1/636 (0.2%) 0/657 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    COLON CANCER 1/636 (0.2%) 1/657 (0.2%)
    GASTRIC CANCER 0/636 (0%) 1/657 (0.2%)
    HEPATIC NEOPLASM MALIGNANT 0/636 (0%) 1/657 (0.2%)
    LUNG NEOPLASM MALIGNANT 1/636 (0.2%) 0/657 (0%)
    METASTASES TO LUNG 0/636 (0%) 1/657 (0.2%)
    Nervous system disorders
    BRAIN STEM STROKE 1/636 (0.2%) 0/657 (0%)
    HYPOXIC-ISCHAEMIC ENCEPHALOPATHY 1/636 (0.2%) 0/657 (0%)
    ISCHAEMIC STROKE 0/636 (0%) 1/657 (0.2%)
    Respiratory, thoracic and mediastinal disorders
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE 24/636 (3.8%) 28/657 (4.3%)
    PNEUMOTHORAX 1/636 (0.2%) 2/657 (0.3%)
    ACUTE RESPIRATORY FAILURE 1/636 (0.2%) 0/657 (0%)
    HAEMOPTYSIS 0/636 (0%) 1/657 (0.2%)
    INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE 1/636 (0.2%) 3/657 (0.5%)
    PNEUMONIA 3/636 (0.5%) 1/657 (0.2%)
    Vascular disorders
    AORTIC ANEURYSM RUPTURE 0/636 (0%) 1/657 (0.2%)
    Other (Not Including Serious) Adverse Events
    Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 61/636 (9.6%) 66/657 (10%)
    Infections and infestations
    Nasopharyngitis 35/636 (5.5%) 32/657 (4.9%)
    Respiratory, thoracic and mediastinal disorders
    Chronic Obstructive Pulmonary Disease 29/636 (4.6%) 36/657 (5.5%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Results Point of Contact

    Name/Title Gerard Lynch
    Organization AstraZeneca
    Phone
    Email aztrial_results_posting@astrazeneca.com
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT01069289
    Other Study ID Numbers:
    • D589DC00007
    First Posted:
    Feb 17, 2010
    Last Update Posted:
    Oct 25, 2012
    Last Verified:
    Sep 1, 2012