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Trial record 24 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

Study to Investigate the Efficacy of Symbicort® SMART. (SAKURA)

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ClinicalTrials.gov Identifier: NCT00839800
Recruitment Status : Completed
First Posted : February 10, 2009
Results First Posted : November 30, 2012
Last Update Posted : November 30, 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: Symbicort Turbuhaler
Drug: Terbutaline Turbuhaler
Enrollment 2091
Recruitment Details The first participant entered the study on 16 February 2009, and the last participant completed the study on 23 February 2011. A total of 3209 participants were enrolled at 148 centres in 13 countries in Asia, America and Europe, and 2091 participants who fulfilled the randomisation criteria were randomised.
Pre-assignment Details The study started with an enrolment visit, Visit 1, 1-7 days prior to Visit 2 (run-in). At Visit 2 patients had to have a reversibility of ≥12% relative to baseline and their pre-bronchodilatory Forced expiratory volume in one second (FEV1) had to be ≥50% of the predicted normal value.
Arm/Group Title Symbicort SMART Symbicort+Terbutaline As Needed
Hide Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
Period Title: Overall Study
Started 1049 1042
Completed 956 932
Not Completed 93 110
Reason Not Completed
Adverse Event             8             12
Lost to Follow-up             31             26
Withdrawal by Subject             28             34
Incorrect Enrolment             3             3
Study-Specific Discontinuation Criteria             6             13
Safety Reasons             2             1
Not Specified             8             14
Severe Non-Compliance to Protocol             7             7
Arm/Group Title Symbicort SMART Symbicort+Terbutaline As Needed Total
Hide Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed Total of all reporting groups
Overall Number of Baseline Participants 1049 1042 2091
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 1049 participants 1042 participants 2091 participants
45.7
(16 to 84)
45.6
(16 to 85)
45.7
(16 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1049 participants 1042 participants 2091 participants
Female
722
  68.8%
692
  66.4%
1414
  67.6%
Male
327
  31.2%
350
  33.6%
677
  32.4%
1.Primary Outcome
Title The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study
Hide Description Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid [GCS] treatment, hospitalization, or emergency room [ER] treatment.
Time Frame week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
Arm/Group Title Symbicort SMART Symbicort+Terbutaline As Needed
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
Overall Number of Participants Analyzed 1049 1042
Measure Type: Number
Unit of Measure: percentage of participants
16 22
2.Secondary Outcome
Title Number of Asthma Exacerbations
Hide Description Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here.
Time Frame up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
Arm/Group Title Symbicort SMART Symbicort+Terbutaline As Needed
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
Overall Number of Participants Analyzed 1049 1042
Measure Type: Number
Unit of Measure: Asthma exacerbations
259 363
3.Secondary Outcome
Title Morning Peak Expiratory Flow (PEF)
Hide Description The mean value from a 52-week treatment period.
Time Frame 52-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
Arm/Group Title Symbicort SMART Symbicort+Terbutaline As Needed
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
Overall Number of Participants Analyzed 1034 1026
Mean (Standard Deviation)
Unit of Measure: Liter/minute (L/min)
331.8  (102.2) 324.7  (101.9)
4.Secondary Outcome
Title Evening PEF
Hide Description The mean value from a 52-week treatment period.
Time Frame 2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
Arm/Group Title Symbicort SMART Symbicort+Terbutaline As Needed
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
Overall Number of Participants Analyzed 1034 1026
Mean (Standard Deviation)
Unit of Measure: L/min
334.2  (102.6) 327.8  (103.1)
5.Secondary Outcome
Title Forced Expiratory Volume in One Second (FEV1)
Hide Description The mean value for Weeks 4, 12, 24, 36 and 52 was analysed.
Time Frame 4, 12, 24, 36 and 52 weeks after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
Arm/Group Title Symbicort SMART Symbicort+Terbutaline As Needed
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
Overall Number of Participants Analyzed 1049 1042
Geometric Mean (Standard Deviation)
Unit of Measure: Liter (L)
2.258  (0.76) 2.222  (0.77)
6.Secondary Outcome
Title Use of As-needed Medication
Hide Description The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time).
Time Frame 52-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
Arm/Group Title Symbicort SMART Symbicort+Terbutaline As Needed
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
Overall Number of Participants Analyzed 1032 1026
Mean (Standard Deviation)
Unit of Measure: inhalations/day
1.21  (1.39) 1.46  (1.60)
7.Secondary Outcome
Title Asthma Symptom Score
Hide Description The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst).
Time Frame 52-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
Arm/Group Title Symbicort SMART Symbicort+Terbutaline As Needed
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
Overall Number of Participants Analyzed 1034 1025
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.12  (1.04) 1.22  (1.02)
8.Secondary Outcome
Title Nights With Awakening(s) Due to Asthma Symptoms
Hide Description The mean value from the treatment period was presented here.
Time Frame 52-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
Arm/Group Title Symbicort SMART Symbicort+Terbutaline As Needed
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
Overall Number of Participants Analyzed 1024 1025
Mean (Standard Deviation)
Unit of Measure: Nights With Awakening(s)
15.7  (27.1) 17.5  (27.2)
9.Secondary Outcome
Title The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations
Hide Description Mild asthma exacerbation was defined as morning PEF ≥20% below baseline, daily as-needed medication use ≥2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here.
Time Frame up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
Arm/Group Title Symbicort SMART Symbicort+Terbutaline As Needed
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
Overall Number of Participants Analyzed 1049 1042
Measure Type: Number
Unit of Measure: percentage of participants
71 80
10.Secondary Outcome
Title Symptom-free Days (no Symptoms and no Awakenings)
Hide Description A symptom-free day was defined as a day without daytime or night-time symptoms and without night-time awakenings due to asthma symptoms. The mean value was presented here.
Time Frame 52-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
Arm/Group Title Symbicort SMART Symbicort+Terbutaline As Needed
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
Overall Number of Participants Analyzed 1034 1026
Mean (Standard Deviation)
Unit of Measure: symptom-free days
45.5  (37.8) 41.6  (37.2)
11.Secondary Outcome
Title Percentage of As-needed-free Days
Hide Description An as-needed-free day is defined as a night and day with no use of as-needed medication. The mean value from the treatment period was presented here.
Time Frame 52-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
Arm/Group Title Symbicort SMART Symbicort+Terbutaline As Needed
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
Overall Number of Participants Analyzed 1032 1026
Mean (Standard Deviation)
Unit of Measure: percentage of as-needed-free days
51.4  (36.7) 47.2  (36.7)
12.Secondary Outcome
Title Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use)
Hide Description An asthma-control day was defined as a a night and day with no asthma symptoms, no awakenings due to asthma symptoms, and no as-needed medication use. The mean value from the treatment period was presented here.
Time Frame 52-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
Arm/Group Title Symbicort SMART Symbicort+Terbutaline As Needed
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
Overall Number of Participants Analyzed 1033 1026
Mean (Standard Deviation)
Unit of Measure: percentage of asthma-control days
41.7  (37.3) 37.9  (36.6)
13.Secondary Outcome
Title Asthma Control Questionnaire (ACQ)
Hide Description The ACQ developed by Juniper and colleagues (Juniper et al 1999) was used without the FEV1 and Beta 2-agonist questions. The Asthma Control Questionnaire has 5 questions that are assessed on a 7-point scale from 0 to 6 where 0 represents good control and 6 represents poor control. The overall score is the mean of the five responses. At least 4 out of the 5 questions must have been answered to provide a value. The mean of the overall score for Weeks 4 to 52 was presented here.
Time Frame 4, 12, 24, 36 and 52 weeks after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
Arm/Group Title Symbicort SMART Symbicort+Terbutaline As Needed
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
Overall Number of Participants Analyzed 1040 1038
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.162  (0.78) 1.289  (0.75)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Symbicort SMART Symbicort+Terbutaline As Needed
Hide Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
All-Cause Mortality
Symbicort SMART Symbicort+Terbutaline As Needed
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Symbicort SMART Symbicort+Terbutaline As Needed
Affected / at Risk (%) Affected / at Risk (%)
Total   41/1049 (3.91%)   74/1042 (7.10%) 
Cardiac disorders     
Acute Myocardial Infarction  1  0/1049 (0.00%)  1/1042 (0.10%) 
Angina Pectoris  1  0/1049 (0.00%)  1/1042 (0.10%) 
Angina Unstable  1  0/1049 (0.00%)  1/1042 (0.10%) 
Coronary Artery Disease  1  0/1049 (0.00%)  1/1042 (0.10%) 
Congenital, familial and genetic disorders     
Cleft Lip  1  1/1049 (0.10%)  0/1042 (0.00%) 
Ear and labyrinth disorders     
Meniere's Disease  1  1/1049 (0.10%)  0/1042 (0.00%) 
Endocrine disorders     
Basedow's Disease  1  0/1049 (0.00%)  1/1042 (0.10%) 
Eye disorders     
Cataract  1  1/1049 (0.10%)  1/1042 (0.10%) 
Retinal Detachment  1  1/1049 (0.10%)  0/1042 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain  1  3/1049 (0.29%)  0/1042 (0.00%) 
Abdominal Hernia  1  0/1049 (0.00%)  1/1042 (0.10%) 
Abdominal Pain Upper  1  0/1049 (0.00%)  1/1042 (0.10%) 
Acute Abdomen  1  0/1049 (0.00%)  1/1042 (0.10%) 
Anal Fissure  1  0/1049 (0.00%)  1/1042 (0.10%) 
Colonic Polyp  1  0/1049 (0.00%)  1/1042 (0.10%) 
Diarrhoea  1  0/1049 (0.00%)  1/1042 (0.10%) 
Gastric Polyps  1  0/1049 (0.00%)  1/1042 (0.10%) 
General disorders     
Hernia Obstructive  1  1/1049 (0.10%)  0/1042 (0.00%) 
Malaise  1  0/1049 (0.00%)  1/1042 (0.10%) 
Pyrexia  1  0/1049 (0.00%)  1/1042 (0.10%) 
Hepatobiliary disorders     
Cholelithiasis  1  1/1049 (0.10%)  0/1042 (0.00%) 
Hepatotoxicity  1  0/1049 (0.00%)  1/1042 (0.10%) 
Immune system disorders     
Drug Hypersensitivity  1  0/1049 (0.00%)  1/1042 (0.10%) 
Infections and infestations     
Pneumonia  1  4/1049 (0.38%)  2/1042 (0.19%) 
Gastroenteritis  1  1/1049 (0.10%)  3/1042 (0.29%) 
Tracheobronchitis  1  2/1049 (0.19%)  0/1042 (0.00%) 
Upper Respiratory Tract Infection Bacterial  1  2/1049 (0.19%)  0/1042 (0.00%) 
Acute Sinusitis  1  1/1049 (0.10%)  0/1042 (0.00%) 
Breast Abscess  1  0/1049 (0.00%)  1/1042 (0.10%) 
Bronchitis  1  0/1049 (0.00%)  1/1042 (0.10%) 
Bronchopneumonia  1  1/1049 (0.10%)  0/1042 (0.00%) 
H1n1 Influenza  1  1/1049 (0.10%)  0/1042 (0.00%) 
Lower Respiratory Tract Infection Bacterial  1  0/1049 (0.00%)  1/1042 (0.10%) 
Osteomyelitis  1  1/1049 (0.10%)  0/1042 (0.00%) 
Otitis Media Chronic  1  1/1049 (0.10%)  0/1042 (0.00%) 
Pneumonia Bacterial  1  1/1049 (0.10%)  0/1042 (0.00%) 
Septic Shock  1  1/1049 (0.10%)  0/1042 (0.00%) 
Tooth Abscess  1  0/1049 (0.00%)  1/1042 (0.10%) 
Urinary Tract Infection  1  1/1049 (0.10%)  0/1042 (0.00%) 
Varicella  1  0/1049 (0.00%)  1/1042 (0.10%) 
Viral Infection  1  0/1049 (0.00%)  1/1042 (0.10%) 
Injury, poisoning and procedural complications     
Traumatic Brain Injury  1  0/1049 (0.00%)  2/1042 (0.19%) 
Foot Fracture  1  0/1049 (0.00%)  1/1042 (0.10%) 
Joint Injury  1  0/1049 (0.00%)  1/1042 (0.10%) 
Lower Limb Fracture  1  0/1049 (0.00%)  1/1042 (0.10%) 
Muscle Strain  1  0/1049 (0.00%)  1/1042 (0.10%) 
Patella Fracture  1  0/1049 (0.00%)  1/1042 (0.10%) 
Sternal Fracture  1  1/1049 (0.10%)  0/1042 (0.00%) 
Metabolism and nutrition disorders     
Type 2 Diabetes Mellitus  1  0/1049 (0.00%)  2/1042 (0.19%) 
Diabetes Mellitus  1  0/1049 (0.00%)  1/1042 (0.10%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  0/1049 (0.00%)  1/1042 (0.10%) 
Intervertebral Disc Protrusion  1  0/1049 (0.00%)  1/1042 (0.10%) 
Rheumatoid Arthritis  1  0/1049 (0.00%)  1/1042 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine Leiomyoma  1  2/1049 (0.19%)  0/1042 (0.00%) 
Breast Cancer In Situ  1  0/1049 (0.00%)  1/1042 (0.10%) 
Intestinal Adenocarcinoma  1  0/1049 (0.00%)  1/1042 (0.10%) 
Metastatic Neoplasm  1  1/1049 (0.10%)  0/1042 (0.00%) 
Rectal Cancer  1  0/1049 (0.00%)  1/1042 (0.10%) 
Nervous system disorders     
Convulsion  1  0/1049 (0.00%)  1/1042 (0.10%) 
Dizziness  1  0/1049 (0.00%)  1/1042 (0.10%) 
Syncope  1  0/1049 (0.00%)  1/1042 (0.10%) 
Pregnancy, puerperium and perinatal conditions     
Abortion Spontaneous  1  1/1049 (0.10%)  1/1042 (0.10%) 
Abortion Threatened  1  1/1049 (0.10%)  0/1042 (0.00%) 
Premature Baby  1  0/1049 (0.00%)  1/1042 (0.10%) 
Psychiatric disorders     
Major Depression  1  1/1049 (0.10%)  0/1042 (0.00%) 
Reproductive system and breast disorders     
Breast Calcifications  1  0/1049 (0.00%)  1/1042 (0.10%) 
Dysfunctional Uterine Bleeding  1  0/1049 (0.00%)  1/1042 (0.10%) 
Endometriosis  1  1/1049 (0.10%)  0/1042 (0.00%) 
Infertility Male  1  1/1049 (0.10%)  0/1042 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  5/1049 (0.48%)  31/1042 (2.98%) 
Dyspnoea  1  1/1049 (0.10%)  2/1042 (0.19%) 
Nasal Septum Deviation  1  1/1049 (0.10%)  0/1042 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  1/1049 (0.10%)  0/1042 (0.00%) 
Vascular disorders     
Hypertension  1  1/1049 (0.10%)  1/1042 (0.10%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Symbicort SMART Symbicort+Terbutaline As Needed
Affected / at Risk (%) Affected / at Risk (%)
Total   279/1049 (26.60%)   293/1042 (28.12%) 
Infections and infestations     
Nasopharyngitis  1  137/1049 (13.06%)  133/1042 (12.76%) 
Bronchitis  1  69/1049 (6.58%)  77/1042 (7.39%) 
Viral Upper Respiratory Tract Infection  1  60/1049 (5.72%)  72/1042 (6.91%) 
Pharyngitis  1  49/1049 (4.67%)  58/1042 (5.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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.
 
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00839800     History of Changes
Other Study ID Numbers: D589LC00001
First Submitted: February 4, 2009
First Posted: February 10, 2009
Results First Submitted: February 21, 2012
Results First Posted: November 30, 2012
Last Update Posted: November 30, 2012