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Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide® (SPEED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00542880
First received: October 10, 2007
Last updated: July 27, 2012
Last verified: July 2012
Results First Received: August 4, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg

  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
706 subjects were enrolled; 264 were not randomised: 190 with eligibility not fulfilled, 11 with adverse events, 4 with discontinuation criteria, 40 voluntary discontinuations, 2 lost to follow-ups, 6 non-compliance, 1 for safety reasons, 10 with other reasons not specified. 442 subjects were randomised

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Symbicort Turbuhaler First, Then Seretide Diskus Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Seretide Diskus First, Then Symbicort Turbuhaler Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg

Participant Flow for 3 periods

Period 1:   Period 1
    Symbicort Turbuhaler First, Then Seretide Diskus     Seretide Diskus First, Then Symbicort Turbuhaler  
STARTED     217 [1]   225  
COMPLETED     211     213  
NOT COMPLETED     6     12  
Eligibility criteria not fulfilled                 2                 6  
Adverse Event                 2                 2  
Development of study-specific criteria                 1                 2  
Withdrawal by Subject                 1                 1  
Protocol Violation                 0                 1  
[1] This was a cross-over study

Period 2:   Period 2
    Symbicort Turbuhaler First, Then Seretide Diskus     Seretide Diskus First, Then Symbicort Turbuhaler  
STARTED     211     213  
COMPLETED     204     203  
NOT COMPLETED     7     10  
Adverse Event                 5                 7  
Eligibility not fulfilled                 0                 1  
Discontinuation criteria                 2                 0  
Severe non-compliance                 0                 1  
Not specified                 0                 1  

Period 3:   Period 3
    Symbicort Turbuhaler First, Then Seretide Diskus     Seretide Diskus First, Then Symbicort Turbuhaler  
STARTED     204     203  
COMPLETED     204     201  
NOT COMPLETED     0     2  
Adverse Event                 0                 2  



  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 First, Then Seretide Diskus Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Seretide Diskus First, Then Symbicort Turbuhaler Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Total Total of all reporting groups

Baseline Measures
    Symbicort Turbuhaler First, Then Seretide Diskus     Seretide Diskus First, Then Symbicort Turbuhaler     Total  
Number of Participants  
[units: participants]
  217     225     442  
Age  
[units: years]
Mean ( Full Range )
  62.9  
  ( 41 to 82 )  
  63.2  
  ( 40 to 86 )  
  63.1  
  ( 40 to 86 )  
Gender  
[units: Participants]
     
Female     55     71     126  
Male     162     154     316  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose   [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]

2.  Secondary:   PEF Before Morning Dose   [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]

3.  Secondary:   PEF 15 Minutes After Morning Dose   [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]

4.  Secondary:   PEF Before Evening Dose   [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]

5.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose   [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]

6.  Secondary:   FEV1 15 Minutes After Morning Dose   [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]

7.  Secondary:   FEV1 Before Evening Dose   [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]

8.  Secondary:   Change in PEF From Before Dose to 5 Minutes After Dose in the Morning   [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]

9.  Secondary:   Change in PEF From Before Dose to 15 Minutes After Dose in the Morning   [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]

10.  Secondary:   Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning   [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]

11.  Secondary:   Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning   [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]

12.  Secondary:   Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic   [ Time Frame: Baseline (run-in, and washout) and day 1 of treatment period ]

13.  Secondary:   Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic   [ Time Frame: Baseline (run-in, and washout) and day 1 of treatment period ]

14.  Secondary:   Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment)   [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]

15.  Secondary:   Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment)   [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]

16.  Secondary:   The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment)   [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]


  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
No text entered.


  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 by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00542880     History of Changes
Other Study ID Numbers: D5892C00016
Study First Received: October 10, 2007
Results First Received: August 4, 2009
Last Updated: July 27, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Ministerie Van Sociale Zaken
Brazil: National Health Surveillance Agency
Denmark: Danish Medicines Agency
Germany: Bundesinstitut für Arzneimittel und Medizin
India: Drug Controller General
Philippines: Bureau of Food and Drugs
United Kingdom: Information Processing Unit - Area 6