Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans (Titan)

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: NCT00702325
Recruitment Status : Completed
First Posted : June 20, 2008
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 Asthma
Interventions Drug: Budesonide / formoterol fumarate (SYMBICORT)
Drug: Budesonide
Enrollment 311
Recruitment Details First participant enrolled on 05 June 2008, last participant last visit on 10 September 2009.
Pre-assignment Details

10 subjects were excluded from the FAS: 9 who received the incorrect study medication and 1 who was randomized to receive SYMBICORT pMDI, but never received study medication.

Therefore, 153 subjects (from 156 randomized to Symbicort) and 148 (from 155 randomized to Budesonide) were included in the FAS used to present baseline characteristics.

Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Period Title: Overall Study
Started 156 [1] 155 [1]
Completed 118 [2] 102 [3]
Not Completed 38 53
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             7             7
Lost to Follow-up             3             4
Incorrect enrollment             5             7
Developed study discontinuation criteria             18             28
Severe noncompliance to protocol             3             3
Termination due to lab results             1             0
Didn't follow study medication dosage             0             2
Withdrew consent             0             1
Incorrectly Discontinued             0             1
[1]
Randomized
[2]
Completed participants based on randomized population (156) minus discontinued participants (38).
[3]
Completed participants based on randomized population (155) minus discontinued participants (53).
Arm/Group Title Symbicort Budesonide Total
Hide Arm/Group Description Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. Total of all reporting groups
Overall Number of Baseline Participants 153 148 301
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 153 participants 148 participants 301 participants
38.6  (13.8) 39.8  (15.4) 39.2  (14.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 148 participants 301 participants
Female
109
  71.2%
87
  58.8%
196
  65.1%
Male
44
  28.8%
61
  41.2%
105
  34.9%
1.Primary Outcome
Title Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period
Hide Description Mean change from baseline (Visit 3) value to average value recorded at visits during 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 Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 150 143
Mean (Standard Deviation)
Unit of Measure: Liters
0.16  (0.31) 0.07  (0.26)
2.Secondary Outcome
Title Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period
Hide Description Mean change from baseline (Visit 3) value to average value recorded at visits during 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 Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 149 139
Mean (Standard Deviation)
Unit of Measure: Liters/minute
25.34  (43.70) 7.53  (32.41)
3.Secondary Outcome
Title Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period
Hide Description Mean change from baseline (Visit 3) value to average value recorded at visits during 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 Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 149 141
Mean (Standard Deviation)
Unit of Measure: Liters/minute
21.61  (40.75) 7.67  (48.97)
4.Secondary Outcome
Title Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period
Hide Description Mean change from baseline (Visit 3) value to average value recorded at visits during 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 Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 150 143
Mean (Standard Deviation)
Unit of Measure: Liters
0.14  (0.32) 0.07  (0.27)
5.Secondary Outcome
Title Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period
Hide Description Mean change of the FEF (25-75%) value at the baseline (Visit 3) compared to average value of the FEF (25-75%) recorded at visits during treatment period (to week 12). The mean change was calculated.
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 Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 150 143
Mean (Standard Deviation)
Unit of Measure: Liters/second
0.21  (0.47) 0.12  (0.47)
6.Secondary Outcome
Title Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry
Hide Description Total number of participants with any first predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma medication)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 153 148
Measure Type: Number
Unit of Measure: Participants
57 67
7.Secondary Outcome
Title Number of Withdrawals Due to a Predefined Asthma Event
Hide Description Total number of participants who withdrew due to a predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma meds)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 153 148
Measure Type: Number
Unit of Measure: Participants
18 28
8.Secondary Outcome
Title Change From Baseline in Total Average Daily Asthma Symptom Score Averaged Over the Treatment Period
Hide Description Diary assessment of total asthma symptoms score (treatment average) by Inhaled Corticosteroid (ICS) dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during 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 Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 149 142
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.35  (0.42) -0.23  (0.40)
9.Secondary Outcome
Title Change From Baseline in Nighttime Asthma Symptom Score Averaged Over the Treatment Period
Hide Description Diary assessment of nighttime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)
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 Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 151 146
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.38  (0.47) -0.26  (0.42)
10.Secondary Outcome
Title Change From Baseline in Daytime Asthma Symptom Score Averaged Over the Treatment Period
Hide Description Diary assessment of daytime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)
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 Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 150 143
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.33  (0.45) -0.24  (0.45)
11.Secondary Outcome
Title Change From Baseline in Awakening-free Nights Averaged Over the Treatment Period
Hide Description Diary assessment of number of nights free from awakenings due to asthma; mean change from baseline (Visit 3) value to average value recorded at visits during 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 Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 150 143
Mean (Standard Deviation)
Unit of Measure: Number of nights
17.51  (26.51) 11.85  (25.92)
12.Secondary Outcome
Title Change From Baseline to the Average in Total Rescue Medication Use Averaged Over the Treatment Period
Hide Description Diary assessment of total daily puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during 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 Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 150 144
Mean (Standard Deviation)
Unit of Measure: Puffs/day
-1.27  (1.81) -0.62  (1.68)
13.Secondary Outcome
Title Change From Baseline to the Average in Nighttime Rescue Medication Use Averaged Over the Treatment Period
Hide Description Diary assessment of total nighttime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during 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 Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 150 144
Mean (Standard Deviation)
Unit of Measure: Puffs/day
-0.79  (1.07) -0.35  (0.93)
14.Secondary Outcome
Title Change From Baseline to the Average in Daytime Medication Use Averaged Over the Treatment Period
Hide Description Diary assessment of total daytime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during 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 Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 150 144
Mean (Standard Deviation)
Unit of Measure: Puffs/day
-0.48  (0.93) -0.27  (0.92)
15.Secondary Outcome
Title Change From Baseline to the Average in Rescue Medication-free Days Averaged Over the Treatment Period
Hide Description Diary assessment of total (percent) days free from rescue medication use for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during 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 Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 150 144
Mean (Standard Deviation)
Unit of Measure: percentage of days
29.31  (34.13) 17.70  (35.39)
16.Secondary Outcome
Title Change From Baseline in Asthma Symptom-free Days Averaged Over the Treatment Period
Hide Description Diary assessment of number (percent) of days free from asthma symptoms by ICS dose at entry; mean change from baseline (Visit 3) value to average value recorded at visits during 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 Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 151 146
Mean (Standard Deviation)
Unit of Measure: percentage of days
23.99  (29.82) 17.55  (28.58)
17.Secondary Outcome
Title Change From Baseline to the Average for Asthma-control Days Averaged Over the Treatment Period
Hide Description Diary assessment of number (percent) of asthma-control days (defined as days that were free of symptoms and nighttime and daytime rescue medication use); mean change from baseline (Visit 3) value to average value recorded at visits during 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 Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 151 147
Mean (Standard Deviation)
Unit of Measure: percentage of days
21.89  (29.48) 15.12  (26.80)
18.Secondary Outcome
Title Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)
Hide Description Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at last week of treatment - During the past week, you could feel your medication begin to work right away
Time Frame 12 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 144 136
Measure Type: Number
Unit of Measure: Participants
12 years and older 123 112
18 years and older 109 95
19.Secondary Outcome
Title Change From Baseline to End of Treatment in Overall Score on the Asthma Quality of Life Questionnaire-Standardized (AQLQ[S])
Hide Description Mean change in overall score at end of treatment for participants age 17 years and older (scores ranged from 1 to 7, with higher scores indicating better quality of life); mean change from baseline (Visit 3) value to average value recorded at visits during 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 Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 125 123
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.55  (0.96) 0.33  (1.07)
20.Secondary Outcome
Title Proportion of Participants Who Reported on the Asthma Control Test (ACT) That Their Asthma Was Controlled at the Last Week of Treatment
Hide Description There are 5 questions in the survey, and each question has 5 responses (total score for each question can range from 1 to 5). To score the survey, responses to the 5 questions are added to yield a total score that ranges from 5 (poor control of asthma control) to 25 (complete control of asthma). Score of 20 or higher was indicative of well-controlled asthma.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 143 139
Measure Type: Number
Unit of Measure: Proportion of Participants
0.524 0.518
21.Secondary Outcome
Title Change From Baseline to Last Week of Treatment in Scores on the Asthma Impact Survey (AIS)
Hide Description There are 6 questions in the survey, and each question has 5 responses (total score for each question can range from 6 to 13). Responses to the 6 questions were added to yield a total score that ranged from 36 to 78. Scoring is based on a norm-based method. Higher AIS scores indicated more asthma impact and poorer quality of life; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period.
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 128 124
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-4.05  (6.79) -2.72  (9.75)
22.Secondary Outcome
Title Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)
Hide Description Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at last week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.
Time Frame 12 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 144 136
Measure Type: Number
Unit of Measure: Participants
12 years and older 112 99
18 years and older 100 81
23.Secondary Outcome
Title Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)
Hide Description Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at first week of treatment - During the past week, you could feel your medication begin to work right away
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 256 234
Measure Type: Number
Unit of Measure: Participants
12 years and older 113 95
18 years and older 101 81
24.Secondary Outcome
Title Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)
Hide Description Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at first week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Number of Participants Analyzed 256 234
Measure Type: Number
Unit of Measure: Participants
12 years and older 96 83
18 years and older 86 70
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
All-Cause Mortality
Symbicort Budesonide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Symbicort Budesonide
Affected / at Risk (%) Affected / at Risk (%)
Total   1/156 (0.64%)   2/155 (1.29%) 
General disorders     
Pyrexia  1  0/156 (0.00%)  1/155 (0.65%) 
Reproductive system and breast disorders     
Ovarian Cyst Ruptured  1  1/156 (0.64%)  0/155 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/156 (0.00%)  1/155 (0.65%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Symbicort Budesonide
Affected / at Risk (%) Affected / at Risk (%)
Total   18/156 (11.54%)   12/155 (7.74%) 
Infections and infestations     
Nasopharyngitis  1  8/156 (5.13%)  4/155 (2.58%) 
Nervous system disorders     
Headache  1  10/156 (6.41%)  8/155 (5.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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.
If Sponsor does not publish within 2 years after study completion, PI is permitted to publish, with confidential information removed from manuscript. Sponsor will have opportunity to review and approve publication at least 60 days pior to being submitted/disclosed. Sponsor can request, in writing, an additional 90 day embargo.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00702325     History of Changes
Other Study ID Numbers: D589BL00003
First Submitted: June 19, 2008
First Posted: June 20, 2008
Results First Submitted: September 20, 2010
Results First Posted: November 9, 2012
Last Update Posted: November 9, 2012