Trial Outcomes & Findings for Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans (NCT NCT00702325)

NCT ID: NCT00702325

Last Updated: 2012-11-09

Results Overview

Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 311 participants
• Primary outcome timeframe: Baseline to 12 weeks
• Results posted on: 2012-11-09

Participant Flow

First participant enrolled on 05 June 2008, last participant last visit on 10 September 2009.

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.

Participant milestones

Measure	Symbicort Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Study STARTED	156	155
Overall Study COMPLETED	118	102
Overall Study NOT COMPLETED	38	53

Reasons for withdrawal

Measure	Symbicort Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	7	7
Overall Study Lost to Follow-up	3	4
Overall Study Incorrect enrollment	5	7
Overall Study Developed study discontinuation criteria	18	28
Overall Study Severe noncompliance to protocol	3	3
Overall Study Termination due to lab results	1	0
Overall Study Didn't follow study medication dosage	0	2
Overall Study Withdrew consent	0	1
Overall Study Incorrectly Discontinued	0	1

Baseline Characteristics

Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans

Baseline characteristics by cohort

Measure	Symbicort n=153 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=148 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.	Total n=301 Participants Total of all reporting groups
Age Continuous	38.6 Years STANDARD_DEVIATION 13.8 • n=93 Participants	39.8 Years STANDARD_DEVIATION 15.4 • n=4 Participants	39.2 Years STANDARD_DEVIATION 14.6 • n=27 Participants
Sex: Female, Male Female	109 Participants n=93 Participants	87 Participants n=4 Participants	196 Participants n=27 Participants
Sex: Female, Male Male	44 Participants n=93 Participants	61 Participants n=4 Participants	105 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

Outcome measures

Measure	Symbicort n=150 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=143 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period	0.16 Liters Standard Deviation 0.31	0.07 Liters Standard Deviation 0.26

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

Outcome measures

Measure	Symbicort n=149 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=139 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period	25.34 Liters/minute Standard Deviation 43.70	7.53 Liters/minute Standard Deviation 32.41

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

Outcome measures

Measure	Symbicort n=149 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=141 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period	21.61 Liters/minute Standard Deviation 40.75	7.67 Liters/minute Standard Deviation 48.97

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

Outcome measures

Measure	Symbicort n=150 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=143 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period	0.14 Liters Standard Deviation 0.32	0.07 Liters Standard Deviation 0.27

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

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.

Outcome measures

Measure	Symbicort n=150 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=143 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period	0.21 Liters/second Standard Deviation 0.47	0.12 Liters/second Standard Deviation 0.47

SECONDARY outcome

Timeframe: 12 weeks

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)

Outcome measures

Measure	Symbicort n=153 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=148 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry	57 Participants	67 Participants

SECONDARY outcome

Timeframe: 12 weeks

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)

Outcome measures

Measure	Symbicort n=153 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=148 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Number of Withdrawals Due to a Predefined Asthma Event	18 Participants	28 Participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

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

Outcome measures

Measure	Symbicort n=149 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=142 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Change From Baseline in Total Average Daily Asthma Symptom Score Averaged Over the Treatment Period	-0.35 Scores on a scale Standard Deviation 0.42	-0.23 Scores on a scale Standard Deviation 0.40

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

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)

Outcome measures

Measure	Symbicort n=151 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=146 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Change From Baseline in Nighttime Asthma Symptom Score Averaged Over the Treatment Period	-0.38 Scores on a scale Standard Deviation 0.47	-0.26 Scores on a scale Standard Deviation 0.42

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

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)

Outcome measures

Measure	Symbicort n=150 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=143 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Change From Baseline in Daytime Asthma Symptom Score Averaged Over the Treatment Period	-0.33 Scores on a scale Standard Deviation 0.45	-0.24 Scores on a scale Standard Deviation 0.45

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

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

Outcome measures

Measure	Symbicort n=150 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=143 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Change From Baseline in Awakening-free Nights Averaged Over the Treatment Period	17.51 Number of nights Standard Deviation 26.51	11.85 Number of nights Standard Deviation 25.92

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

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

Outcome measures

Measure	Symbicort n=150 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=144 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Change From Baseline to the Average in Total Rescue Medication Use Averaged Over the Treatment Period	-1.27 Puffs/day Standard Deviation 1.81	-0.62 Puffs/day Standard Deviation 1.68

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

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

Outcome measures

Measure	Symbicort n=150 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=144 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Change From Baseline to the Average in Nighttime Rescue Medication Use Averaged Over the Treatment Period	-0.79 Puffs/day Standard Deviation 1.07	-0.35 Puffs/day Standard Deviation 0.93

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

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

Outcome measures

Measure	Symbicort n=150 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=144 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Change From Baseline to the Average in Daytime Medication Use Averaged Over the Treatment Period	-0.48 Puffs/day Standard Deviation 0.93	-0.27 Puffs/day Standard Deviation 0.92

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

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

Outcome measures

Measure	Symbicort n=150 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=144 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Change From Baseline to the Average in Rescue Medication-free Days Averaged Over the Treatment Period	29.31 percentage of days Standard Deviation 34.13	17.70 percentage of days Standard Deviation 35.39

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

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

Outcome measures

Measure	Symbicort n=151 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=146 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Change From Baseline in Asthma Symptom-free Days Averaged Over the Treatment Period	23.99 percentage of days Standard Deviation 29.82	17.55 percentage of days Standard Deviation 28.58

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

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

Outcome measures

Measure	Symbicort n=151 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=147 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Change From Baseline to the Average for Asthma-control Days Averaged Over the Treatment Period	21.89 percentage of days Standard Deviation 29.48	15.12 percentage of days Standard Deviation 26.80

SECONDARY outcome

Timeframe: 12 week

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

Outcome measures

Measure	Symbicort n=144 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=136 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
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) 12 years and older	123 Participants	112 Participants
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) 18 years and older	109 Participants	95 Participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

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

Outcome measures

Measure	Symbicort n=125 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=123 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Change From Baseline to End of Treatment in Overall Score on the Asthma Quality of Life Questionnaire-Standardized (AQLQ[S])	0.55 Scores on a scale Standard Deviation 0.96	0.33 Scores on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Measure	Symbicort n=143 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=139 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Proportion of Participants Who Reported on the Asthma Control Test (ACT) That Their Asthma Was Controlled at the Last Week of Treatment	0.524 Proportion of Participants	0.518 Proportion of Participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks

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.

Outcome measures

Measure	Symbicort n=128 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=124 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Change From Baseline to Last Week of Treatment in Scores on the Asthma Impact Survey (AIS)	-4.05 Scores on a scale Standard Deviation 6.79	-2.72 Scores on a scale Standard Deviation 9.75

SECONDARY outcome

Timeframe: 12 week

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.

Outcome measures

Measure	Symbicort n=144 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=136 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
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) 12 years and older	112 Participants	99 Participants
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) 18 years and older	100 Participants	81 Participants

SECONDARY outcome

Timeframe: 1 week

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

Outcome measures

Measure	Symbicort n=256 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=234 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
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) 12 years and older	113 Participants	95 Participants
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) 18 years and older	101 Participants	81 Participants

SECONDARY outcome

Timeframe: 1 week

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.

Outcome measures

Measure	Symbicort n=256 Participants Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=234 Participants Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
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) 12 years and older	96 Participants	83 Participants
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) 18 years and older	86 Participants	70 Participants

Adverse Events

Symbicort

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Budesonide

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Symbicort n=156 participants at risk Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=155 participants at risk Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
General disorders Pyrexia	0.00% 0/156	0.65% 1/155
Reproductive system and breast disorders Ovarian Cyst Ruptured	0.64% 1/156	0.00% 0/155
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/156	0.65% 1/155

Other adverse events

Measure	Symbicort n=156 participants at risk Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.	Budesonide n=155 participants at risk Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
Infections and infestations Nasopharyngitis	5.1% 8/156	2.6% 4/155
Nervous system disorders Headache	6.4% 10/156	5.2% 8/155

Additional Information

Gerard Lynch

AstraZeneca

Email: aztrial_results_posting@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER