Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients (SUMIRE)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01069289
First received: February 11, 2010
Last updated: September 25, 2012
Last verified: September 2012
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069289
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| 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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| Davao City, Philippines | |
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| Barnaul, Russia, Russian Federation | |
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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 May 23, 2013