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Trial record 5 of 12 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol) | ( Map: France )

Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00496470
Recruitment Status : Completed
First Posted : July 4, 2007
Results First Posted : November 9, 2012
Last Update Posted : November 9, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease, COPD
Interventions Drug: Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Drug: Spiriva (tiotropium bromide 18ug)
Enrollment 660
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Period Title: Overall Study
Started 329 331
Received Study Medication 329 330
Completed 303 302
Not Completed 26 29
Reason Not Completed
Adverse Event             8             10
Withdrawal by Subject             5             12
Incorrectly enrolled             13             5
Other reason             0             2
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium Total
Hide Arm/Group Description Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily Total of all reporting groups
Overall Number of Baseline Participants 329 331 660
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 329 participants 331 participants 660 participants
62.4
(40 to 85)
62.5
(41 to 82)
62.45
(40 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 329 participants 331 participants 660 participants
Female
78
  23.7%
86
  26.0%
164
  24.8%
Male
251
  76.3%
245
  74.0%
496
  75.2%
1.Primary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1) Pre-dose
Hide Description Change in the pre-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 323 327
Mean (Standard Deviation)
Unit of Measure: Liters
0.064  (0.198) -0.001  (0.168)
2.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose
Hide Description Change in the 5 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 329 330
Mean (Standard Deviation)
Unit of Measure: Liters
0.165  (0.184) 0.042  (0.14)
3.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1) 60 Min Post-dose
Hide Description Change in the 60 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 329 330
Mean (Standard Deviation)
Unit of Measure: Liters
0.214  (0.209) 0.083  (0.157)
4.Secondary Outcome
Title Forced Vital Capacity (FVC) Pre-dose
Hide Description Change in the pre-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 323 327
Mean (Standard Deviation)
Unit of Measure: Liters
0.07  (0.341) 0.014  (0.348)
5.Secondary Outcome
Title Forced Vital Capacity (FVC) 5 Minutes Post-dose
Hide Description Change in the 5 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 329 330
Mean (Standard Deviation)
Unit of Measure: Liters
0.266  (0.32) 0.106  (0.296)
6.Secondary Outcome
Title Forced Vital Capacity (FVC) 60 Minutes Post-dose
Hide Description Change in the 60 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 329 330
Mean (Standard Deviation)
Unit of Measure: Liters
0.353  (0.357) 0.19  (0.319)
7.Secondary Outcome
Title Inspiratory Capacity (IC) Pre-dose
Hide Description Change in the pre-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 314 309
Mean (Standard Deviation)
Unit of Measure: Liters
0.078  (0.35) 0.014  (0.389)
8.Secondary Outcome
Title Inspiratory Capacity (IC) 60 Minutes Post-dose
Hide Description Change in the 60 min post-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 318 310
Mean (Standard Deviation)
Unit of Measure: Liters
0.26  (0.353) 0.149  (0.359)
9.Secondary Outcome
Title St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score
Hide Description

Change in total score from baseline (Visit 3) to end of treatment (Visit 6, or last available visit).

SGRQ-C is a health related quality of life questionnaire consisting of 40 items divided into two components: 1) symptoms, 2) activity& impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.

Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 315 320
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-4.12  (12.81) -1.99  (12.77)
10.Secondary Outcome
Title Morning Peak Expiratory Flow (PEF) Pre-dose
Hide Description Daily diary record. Change in average values from run-in to the full treatment period
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 329 330
Mean (Standard Deviation)
Unit of Measure: Liters/minute
5.12  (38.3) -3.52  (24.7)
11.Secondary Outcome
Title Evening Peak Expiratory Flow (PEF) Pre-dose
Hide Description Daily diary record. Change in average values from run-in to the full treatment period
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 329 329
Mean (Standard Deviation)
Unit of Measure: Liters/minute
2.82  (37.6) -5.54  (28.9)
12.Secondary Outcome
Title Morning Peak Expiratory Flow (PEF) 5 Min Post-dose
Hide Description Daily diary record. Change in average values from run-in to the full treatment period
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 294 307
Mean (Standard Deviation)
Unit of Measure: Liters/minute
16.71  (42.6) 1.1  (26.5)
13.Secondary Outcome
Title Morning Peak Expiratory Flow (PEF) 15 Min Post-dose
Hide Description Daily diary record. Change in average values from run-in to the full treatment period
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 293 311
Mean (Standard Deviation)
Unit of Measure: Liters/minute
20.4  (43.7) 5.2  (28.3)
14.Secondary Outcome
Title Morning Diary FEV1 Pre-dose
Hide Description Daily diary record. Change in average values from run-in to the full treatment period
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 219 233
Mean (Standard Deviation)
Unit of Measure: Liters
0.054  (0.201) -0.046  (0.185)
15.Secondary Outcome
Title Evening Diary FEV1, Pre-dose
Hide Description Daily diary record. Change in average values from run-in to the full treatment period
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 221 237
Mean (Standard Deviation)
Unit of Measure: Liters
0.012  (0.223) -0.065  (0.249)
16.Secondary Outcome
Title Morning Diary FEV1, 5 Minutes Post-dose
Hide Description Daily diary record. Change in average values from run-in to the full treatment period
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 191 205
Mean (Standard Deviation)
Unit of Measure: Liters
0.169  (0.224) -0.018  (0.189)
17.Secondary Outcome
Title Morning Diary FEV1, 15 Minutes Post-dose
Hide Description Daily diary record. Change in average values from run-in to the full treatment period
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 190 208
Mean (Standard Deviation)
Unit of Measure: Liters
0.209  (0.236) 0.014  (0.201)
18.Secondary Outcome
Title Global Chest Symptoms Questionnaire (GCSQ) Score, Pre-dose
Hide Description

Daily diary record. Change in average values from run-in to the full treatment period.

The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions.

Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 329 328
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.143  (0.453) -0.006  (0.438)
19.Secondary Outcome
Title GCSQ Score, 5 Minutes Post-dose
Hide Description

Daily diary record. Change in average values from run-in to the full treatment period.

The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions.

Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 296 305
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.325  (0.508) -0.202  (0.46)
20.Secondary Outcome
Title GCSQ Score, 15 Minutes Post-dose
Hide Description

Daily diary record. Change in average values from run-in to the full treatment period.

The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions.

Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 293 309
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.404  (-0.526) -0.28  (-0.501)
21.Secondary Outcome
Title Capacity of Day Living in the Morning (CDLM) Score
Hide Description

Daily diary record. Change in average values from run-in to the full treatment period.

The CDLM questionnaire is as a questionnaire to report on patient’s ability to carry out each of six different morning activities (score ranging from 0 “not performed” to 1”performed”) and rank the difficulty of performing each of those activities (score ranging from 0 “so difficult that the activity could not be carried out by the patient on their own” to 5 “activity was not at all difficult to carry out”. Total score for each morning activity range from 0-6. Total score for whole CDLM questionnaire range from 0-36.

Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 281 294
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.202  (0.467) 0.07  (0.435)
22.Secondary Outcome
Title Use of Rescue Medication, Night
Hide Description Daily diary record - Night, after evening measurement till morning. Change in average values from run-in to the full treatment period
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 329 330
Mean (Standard Deviation)
Unit of Measure: Inhalations
-0.279  (0.7) 0.022  (0.743)
23.Secondary Outcome
Title Use of Rescue Medication, Morning
Hide Description Daily diary record - Morning, after morning measurement till midday. Change in average values from run-in to the full treatment period
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 281 294
Mean (Standard Deviation)
Unit of Measure: Inhalations
-0.417  (0.758) -0.124  (0.877)
24.Secondary Outcome
Title Use of Rescue Medication, Day
Hide Description Daily diary record - Day, after morning measurement till evening. Change in average values from run-in to the full treatment period
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 329 329
Mean (Standard Deviation)
Unit of Measure: Inhalations
-0.745  (1.286) -0.371  (1.622)
25.Secondary Outcome
Title Use of Rescue Medication, Total
Hide Description Daily diary record - Total, 24 hours, during the night, and during the day. Change in average values from run-in to the full treatment period
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 329 329
Mean (Standard Deviation)
Unit of Measure: Inhalations
-1.024  (1.704) -0.347  (2.102)
26.Secondary Outcome
Title COPD Symptoms, Breathing Score
Hide Description Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 329 329
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-0.177  (0.503) -0.049  (0.5)
27.Secondary Outcome
Title COPD Symptoms, Sleeping Score
Hide Description Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 329 330
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-0.197  (0.45) -0.045  (0.462)
28.Secondary Outcome
Title COPD Symptoms, Chest Score
Hide Description Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 329 329
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-0.184  (0.5) -0.061  (0.473)
29.Secondary Outcome
Title COPD Symptoms, Cough Score
Hide Description Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 329 329
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-0.246  (0.567) -0.079  (0.545)
30.Secondary Outcome
Title Severe COPD Exacerbations
Hide Description Patients with worsening of COPD leading to treatment with systemic steroids (oral or parenteral), emergency room treatment or hospitalisation
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 329 330
Measure Type: Number
Unit of Measure: Participants
25 61
31.Secondary Outcome
Title Serum High-sensitivity C-reactive Protein (hsCRP)
Hide Description Ratio of treatment period mean to run-in value
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 304 309
Median (Inter-Quartile Range)
Unit of Measure: Ratio
0.91
(0.5 to 1.76)
0.97
(0.6 to 1.54)
32.Secondary Outcome
Title Serum Interleukin 6 (IL-6)
Hide Description Ratio of treatment period mean to run-in value
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 304 309
Median (Inter-Quartile Range)
Unit of Measure: Ratio
1.0
(0.72 to 1.56)
1.0
(0.67 to 1.56)
33.Secondary Outcome
Title Serum Interleukin 8 (IL-8)
Hide Description Ratio of treatment period mean to run-in value
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 304 309
Median (Inter-Quartile Range)
Unit of Measure: Ratio
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.0)
34.Secondary Outcome
Title Serum Monocyte Chemoattractant Protein-1 (MCP-1)
Hide Description Ratio of treatment period mean to run-in value
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 304 309
Median (Inter-Quartile Range)
Unit of Measure: Ratio
0.95
(0.78 to 1.15)
0.95
(0.79 to 1.11)
35.Secondary Outcome
Title Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha)
Hide Description Ratio of treatment period mean to run-in value
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 304 309
Median (Inter-Quartile Range)
Unit of Measure: Ratio
0.97
(0.85 to 1.08)
0.98
(0.88 to 1.1)
36.Secondary Outcome
Title Serum Tumor Necrosis Factor-alpha (TNF-alpha)
Hide Description Ratio of treatment period mean to run-in value
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 304 309
Median (Inter-Quartile Range)
Unit of Measure: Ratio
1.0
(0.69 to 1.28)
1.0
(0.67 to 1.2)
37.Secondary Outcome
Title Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)
Hide Description Ratio of treatment period mean to run-in value
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description:
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Overall Number of Participants Analyzed 304 309
Median (Inter-Quartile Range)
Unit of Measure: Ratio
0.96
(0.87 to 1.06)
0.99
(0.91 to 1.09)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Symbicort+Tiotropium Placebo+Tiotropium
Hide Arm/Group Description Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
All-Cause Mortality
Symbicort+Tiotropium Placebo+Tiotropium
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Symbicort+Tiotropium Placebo+Tiotropium
Affected / at Risk (%) Affected / at Risk (%)
Total   10/329 (3.04%)   16/330 (4.85%) 
Cardiac disorders     
Acute Coronary Syndrome   1/329 (0.30%)  0/330 (0.00%) 
Atrioventricular Block Second Degree   0/329 (0.00%)  1/330 (0.30%) 
Infections and infestations     
Infective Exacerbation of Chronic Obstructive Airways Disease   2/329 (0.61%)  2/330 (0.61%) 
Pneomonia   1/329 (0.30%)  1/330 (0.30%) 
Injury, poisoning and procedural complications     
Pelvic Fracture   0/329 (0.00%)  1/330 (0.30%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma Pancreas   0/329 (0.00%)  1/330 (0.30%) 
Lung Neoplasm   1/329 (0.30%)  0/330 (0.00%) 
Lung Neoplasm Malignant   1/329 (0.30%)  0/330 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic Obstructive Pulmonary Disease   3/329 (0.91%)  8/330 (2.42%) 
Bronchospasm   0/329 (0.00%)  1/330 (0.30%) 
Haemoptysis   0/329 (0.00%)  1/330 (0.30%) 
Pleuritic Pain   1/329 (0.30%)  0/330 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Symbicort+Tiotropium Placebo+Tiotropium
Affected / at Risk (%) Affected / at Risk (%)
Total   0/329 (0.00%)   0/330 (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
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: ClinicalTrialTransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00496470     History of Changes
Other Study ID Numbers: D5892C00015
Eudract no:2006-006796-21
First Submitted: July 3, 2007
First Posted: July 4, 2007
Results First Submitted: June 15, 2009
Results First Posted: November 9, 2012
Last Update Posted: November 9, 2012