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Completed

NCT Number: NCT01069289

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Bangalore, Karnataka, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide/formoterol (Symbicort Turbuhaler)

Drug

2x160/4.5 microgram, inhalation, twice daily, 12 weeks

Other names: Symbicort Turbuhaler

Formoterol (Oxis Turbuhaler)

Drug

2 X 4.5 microgram, inhalation, twice daily, 12 weeks

Other names: Oxis Turbuhaler

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

  15. 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.

  16. 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).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: SUMIRE

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 17, 2010
Registry last updated
Oct 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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