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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01069289
First received: February 11, 2010
Last updated: September 25, 2012
Last verified: September 2012

February 11, 2010
September 25, 2012
January 2010
March 2011   (final data collection date for primary outcome measure)
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
Forced Expiratory Flow in one second [ Time Frame: In the mornings before intake of study drugs, every 4 weeks, at clinics ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01069289 on ClinicalTrials.gov Archive Site
  • 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).
  • COPD symptoms [ Time Frame: Every morning and evening during 14 weeks ] [ Designated as safety issue: No ]
  • COPD exacerbation [ Time Frame: At 1-2 weeks before start of randomized treatment, at the start of randomized treatment and 4, 8 and 12 weeks after start of the randomized treatment ] [ Designated as safety issue: No ]
  • St George's Respiratory Questionnaire (SGRQ) [ Time Frame: the start of randomized treatment and 4, 8 and 12 weeks after start of the randomized treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Budesonide/formoterol (Symbicort Turbuhaler)
    2x160/4.5 microgram, inhalation, twice daily, 12 weeks
    Other Name: Symbicort Turbuhaler
  • Drug: Formoterol (Oxis Turbuhaler)
    2 X 4.5 microgram, inhalation, twice daily, 12 weeks
    Other Name: Oxis Turbuhaler
  • Experimental: 1
    Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily
    Intervention: Drug: Budesonide/formoterol (Symbicort Turbuhaler)
  • Active Comparator: 2
    Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily
    Intervention: Drug: Formoterol (Oxis Turbuhaler)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1293
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India,   Japan,   Korea, Republic of,   Philippines,   Poland,   Russian Federation,   Taiwan,   Ukraine,   Vietnam
 
NCT01069289
D589DC00007
No
AstraZeneca
AstraZeneca
Not Provided
Study Chair: Lars-Göran Carlsson, MD AstraZeneca R&D, Lund, Sweden
Principal Investigator: Yoshinosuke Fukuchi, M.D., PhD Department of Respiratory medicine, Juntendo University
AstraZeneca
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP