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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
Results First Received: March 21, 2012  
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
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: Budesonide/formoterol (Symbicort Turbuhaler)
Drug: Formoterol (Oxis Turbuhaler)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Symbicort Turbuhaler (Experimental) Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler (Active Comparator) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)

Participant Flow:   Overall Study
    Symbicort Turbuhaler (Experimental)     Oxis Turbuhaler (Active Comparator)  
STARTED     636     657  
COMPLETED     594     601  
NOT COMPLETED     42     56  
Withdrawal by Subject                 15                 26  
Adverse Event                 21                 28  
Eligibility criteria not fulfilled                 2                 0  
Severe non-compliance to protocol                 3                 2  
Due to deteriorating health condition                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Symbicort Turbuhaler (Experimental) Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler (Active Comparator) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Total Total of all reporting groups

Baseline Measures
    Symbicort Turbuhaler (Experimental)     Oxis Turbuhaler (Active Comparator)     Total  
Number of Participants  
[units: participants]
  636     657     1293  
Age  
[units: Years]
Mean ( Full Range )
  64.5  
  ( 40 to 89 )  
  65.6  
  ( 40 to 87 )  
  65.1  
  ( 40 to 89 )  
Gender  
[units: Participants]
     
Female     79     64     143  
Male     557     593     1150  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pre-dose Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Before randomization, 0, 4, 8 and 12 weeks after randomization ]

2.  Secondary:   1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Before randomization, 0, 4, 8 and 12 weeks after randomization ]

3.  Secondary:   Pre-dose Forced Vital Capacity (FVC)   [ Time Frame: Before randomization, 0, 4, 8 and 12 weeks after randomization ]

4.  Secondary:   1 Hour Post-dose Forced Vital Capacity (FVC)   [ Time Frame: Before randomization, 0, 4, 8 and 12 weeks after randomization ]

5.  Secondary:   Percentage of Participants With Exacerbations   [ Time Frame: Daily during 12-week randomization treatment ]

6.  Secondary:   Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation   [ Time Frame: Daily during 12-week randomization treatment ]

7.  Secondary:   Morning Peak Expiratory Flow(PEF)   [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ]

8.  Secondary:   Evening Peak Expiratory Flow (PEF)   [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ]

9.  Secondary:   Total Number of Day With Exacerbation   [ Time Frame: Daily during 12-week randomization treatment ]

10.  Secondary:   Morning Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ]

11.  Secondary:   Evening Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ]

12.  Secondary:   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 ]

13.  Secondary:   Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms   [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ]

14.  Secondary:   Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms   [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ]

15.  Secondary:   Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score   [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ]

16.  Secondary:   Use of Rescue Medication   [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ]

17.  Secondary:   St George’s Respiratory Questionnaire (SGRQ) Total Score   [ Time Frame: Daily during run-in period and daily during 12-week randomization treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


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