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Trial record 37 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

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

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ClinicalTrials.gov Identifier: NCT00542880
Recruitment Status : Completed
First Posted : October 12, 2007
Results First Posted : August 30, 2012
Last Update Posted : August 30, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, 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
Enrollment 442
Recruitment Details 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  
Arm/Group Title Symbicort Turbuhaler First, Then Seretide Diskus Seretide Diskus First, Then Symbicort Turbuhaler
Hide Arm/Group Description Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Period Title: Period 1
Started 217 [1] 225
Completed 211 213
Not Completed 6 12
Reason Not Completed
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 Title: Period 2
Started 211 213
Completed 204 203
Not Completed 7 10
Reason Not Completed
Adverse Event             5             7
Eligibility not fulfilled             0             1
Discontinuation criteria             2             0
Severe non-compliance             0             1
Not specified             0             1
Period Title: Period 3
Started 204 203
Completed 204 201
Not Completed 0 2
Reason Not Completed
Adverse Event             0             2
Arm/Group Title Symbicort Turbuhaler First, Then Seretide Diskus Seretide Diskus First, Then Symbicort Turbuhaler Total
Hide Arm/Group Description Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg Total of all reporting groups
Overall Number of Baseline Participants 217 225 442
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 217 participants 225 participants 442 participants
62.9
(41 to 82)
63.2
(40 to 86)
63.1
(40 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 217 participants 225 participants 442 participants
Female
55
  25.3%
71
  31.6%
126
  28.5%
Male
162
  74.7%
154
  68.4%
316
  71.5%
1.Primary Outcome
Title Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose
Hide Description The change from baseline in PEF was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and all days of treatment, with baseline as covariate.
Time Frame Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Turbuhaler Seretide Diskus
Hide Arm/Group Description:
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Overall Number of Participants Analyzed 385 390
Mean (Standard Deviation)
Unit of Measure: liters/minute
15.1  (28.5) 13.4  (28.2)
2.Secondary Outcome
Title PEF Before Morning Dose
Hide Description The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
Time Frame Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Turbuhaler Seretide Diskus
Hide Arm/Group Description:
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Overall Number of Participants Analyzed 416 425
Mean (Standard Deviation)
Unit of Measure: Liters/minutes
4.8  (28.2) 7.9  (24)
3.Secondary Outcome
Title PEF 15 Minutes After Morning Dose
Hide Description The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
Time Frame Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Turbuhaler Seretide Diskus
Hide Arm/Group Description:
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Overall Number of Participants Analyzed 377 389
Mean (Standard Deviation)
Unit of Measure: Liters/minute
19.9  (30.3) 16.7  (28.5)
4.Secondary Outcome
Title PEF Before Evening Dose
Hide Description The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
Time Frame Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Turbuhaler Seretide Diskus
Hide Arm/Group Description:
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Overall Number of Participants Analyzed 418 426
Mean (Standard Deviation)
Unit of Measure: Liters/minute
4  (24.3) 1.8  (50)
5.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose
Hide Description The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
Time Frame Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects with at least one dose of study medication and contribute sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Turbuhaler Seretide Diskus
Hide Arm/Group Description:
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Overall Number of Participants Analyzed 280 269
Mean (Standard Deviation)
Unit of Measure: Liters
0.0310  (0.2460) 0.0590  (0.2310)
6.Secondary Outcome
Title FEV1 15 Minutes After Morning Dose
Hide Description The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
Time Frame Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects with at least one dose of study medication and contribute sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Turbuhaler Seretide Diskus
Hide Arm/Group Description:
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Overall Number of Participants Analyzed 249 249
Mean (Standard Deviation)
Unit of Measure: Liters
0.1220  (0.2530) 0.1030  (0.3720)
7.Secondary Outcome
Title FEV1 Before Evening Dose
Hide Description The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
Time Frame Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Turbuhaler Seretide Diskus
Hide Arm/Group Description:
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Overall Number of Participants Analyzed 248 243
Mean (Standard Deviation)
Unit of Measure: Liters
0.1470  (0.2470) 0.1060  (0.2010)
8.Secondary Outcome
Title Change in PEF From Before Dose to 5 Minutes After Dose in the Morning
Hide Description The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with pre-dose run-in/washout as covariate.
Time Frame Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Turbuhaler Seretide Diskus
Hide Arm/Group Description:
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Overall Number of Participants Analyzed 279 279
Mean (Standard Deviation)
Unit of Measure: Liters/minute
0.0160  (0.2) 0.0030  (0.299)
9.Secondary Outcome
Title Change in PEF From Before Dose to 15 Minutes After Dose in the Morning
Hide Description The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.
Time Frame Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Turbuhaler Seretide Diskus
Hide Arm/Group Description:
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Overall Number of Participants Analyzed 368 376
Mean (Standard Deviation)
Unit of Measure: Liters/minute
11.6  (16.2) 6.1  (16.5)
10.Secondary Outcome
Title Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning
Hide Description The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.
Time Frame Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Turbuhaler Seretide Diskus
Hide Arm/Group Description:
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Overall Number of Participants Analyzed 368 376
Mean (Standard Deviation)
Unit of Measure: Liters
15.8  (20.8) 9.6  (19.9)
11.Secondary Outcome
Title Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning
Hide Description The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.
Time Frame Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Turbuhaler Seretide Diskus
Hide Arm/Group Description:
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Overall Number of Participants Analyzed 233 238
Mean (Standard Deviation)
Unit of Measure: Liters
0.0930  (0.1870) 0.0280  (0.1630)
12.Secondary Outcome
Title Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic
Hide Description The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.
Time Frame Baseline (run-in, and washout) and day 1 of treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Turbuhaler Seretide Diskus
Hide Arm/Group Description:
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Overall Number of Participants Analyzed 233 238
Mean (Standard Deviation)
Unit of Measure: Liters
0.1120  (0.1950) 0.0440  (0.1640)
13.Secondary Outcome
Title Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic
Hide Description The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.
Time Frame Baseline (run-in, and washout) and day 1 of treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Turbuhaler Seretide Diskus
Hide Arm/Group Description:
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Overall Number of Participants Analyzed 415 426
Mean (Standard Deviation)
Unit of Measure: Liters
0.0950  (0.1370) 0.0490  (0.1060)
14.Secondary Outcome
Title Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment)
Hide Description The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.
Time Frame Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Turbuhaler Seretide Diskus First
Hide Arm/Group Description:
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Overall Number of Participants Analyzed 415 426
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.1920  (0.2530) 0.1240  (0.2310)
15.Secondary Outcome
Title Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment)
Hide Description The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.
Time Frame Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Turbuhaler Seretide Diskus
Hide Arm/Group Description:
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Overall Number of Participants Analyzed 319 311
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.21  (0.64) 0.14  (0.75)
16.Secondary Outcome
Title The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment)
Hide Description The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 6 with 0=worst and 6 = best.
Time Frame Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Turbuhaler Seretide Diskus
Hide Arm/Group Description:
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Overall Number of Participants Analyzed 394 396
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.24  (0.75) 0.19  (0.73)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Symbicort Turbuhaler Seretide Diskus
Hide Arm/Group Description Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg Seretide Diskus (salmeterol/fluticasone) 50/500 μg
All-Cause Mortality
Symbicort Turbuhaler Seretide Diskus
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Symbicort Turbuhaler Seretide Diskus
Affected / at Risk (%) Affected / at Risk (%)
Total   3/420 (0.71%)   1/429 (0.23%) 
General disorders     
Gait disturbance  1  1/420 (0.24%)  0/429 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive oulmonary disease  1  2/420 (0.48%)  1/429 (0.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Symbicort Turbuhaler Seretide Diskus
Affected / at Risk (%) Affected / at Risk (%)
Total   0/420 (0.00%)   0/429 (0.00%) 
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.
Prior to any publication or disclosure, the PI provides AstraZeneca with preliminary data and drafts and with the proposed final manuscript. AstraZeneca shall have a period of 30 days from receipt of the proposed final manuscript to review it and may within such time frame require that submission for publication or disclosure be delayed.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00542880     History of Changes
Other Study ID Numbers: D5892C00016
First Submitted: October 10, 2007
First Posted: October 12, 2007
Results First Submitted: August 4, 2009
Results First Posted: August 30, 2012
Last Update Posted: August 30, 2012