Trial Outcomes & Findings for Study to Investigate the Efficacy of Symbicort® SMART. (NCT NCT00839800)
NCT ID: NCT00839800
Last Updated: 2012-11-30
Results Overview
Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid \[GCS\] treatment, hospitalization, or emergency room \[ER\] treatment.
COMPLETED
PHASE3
2091 participants
week 52
2012-11-30
Participant Flow
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.
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.
Participant milestones
| Measure |
Symbicort SMART
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
|---|---|---|
|
Overall Study
STARTED
|
1049
|
1042
|
|
Overall Study
COMPLETED
|
956
|
932
|
|
Overall Study
NOT COMPLETED
|
93
|
110
|
Reasons for withdrawal
| Measure |
Symbicort SMART
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
12
|
|
Overall Study
Lost to Follow-up
|
31
|
26
|
|
Overall Study
Withdrawal by Subject
|
28
|
34
|
|
Overall Study
Incorrect Enrolment
|
3
|
3
|
|
Overall Study
Study-Specific Discontinuation Criteria
|
6
|
13
|
|
Overall Study
Safety Reasons
|
2
|
1
|
|
Overall Study
Other
|
8
|
14
|
|
Overall Study
Severe Non-Compliance to Protocol
|
7
|
7
|
Baseline Characteristics
Study to Investigate the Efficacy of Symbicort® SMART.
Baseline characteristics by cohort
| Measure |
Symbicort SMART
n=1049 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
n=1042 Participants
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
Total
n=2091 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
45.7 years
n=5 Participants
|
45.6 years
n=7 Participants
|
45.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
722 Participants
n=5 Participants
|
692 Participants
n=7 Participants
|
1414 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
327 Participants
n=5 Participants
|
350 Participants
n=7 Participants
|
677 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 52Population: The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid \[GCS\] treatment, hospitalization, or emergency room \[ER\] treatment.
Outcome measures
| Measure |
Symbicort SMART
n=1049 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
n=1042 Participants
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
|---|---|---|
|
The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study
|
16 percentage of participants
|
22 percentage of participants
|
SECONDARY outcome
Timeframe: up to 52 weeksPopulation: The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
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.
Outcome measures
| Measure |
Symbicort SMART
n=1049 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
n=1042 Participants
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
|---|---|---|
|
Number of Asthma Exacerbations
|
259 Asthma exacerbations
|
363 Asthma exacerbations
|
SECONDARY outcome
Timeframe: 52-week treatment periodPopulation: The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
The mean value from a 52-week treatment period.
Outcome measures
| Measure |
Symbicort SMART
n=1034 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
n=1026 Participants
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
|---|---|---|
|
Morning Peak Expiratory Flow (PEF)
|
331.8 Liter/minute (L/min)
Standard Deviation 102.2
|
324.7 Liter/minute (L/min)
Standard Deviation 101.9
|
SECONDARY outcome
Timeframe: 2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment periodPopulation: The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
The mean value from a 52-week treatment period.
Outcome measures
| Measure |
Symbicort SMART
n=1034 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
n=1026 Participants
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
|---|---|---|
|
Evening PEF
|
334.2 L/min
Standard Deviation 102.6
|
327.8 L/min
Standard Deviation 103.1
|
SECONDARY outcome
Timeframe: 4, 12, 24, 36 and 52 weeks after randomizationPopulation: The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
The mean value for Weeks 4, 12, 24, 36 and 52 was analysed.
Outcome measures
| Measure |
Symbicort SMART
n=1049 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
n=1042 Participants
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1)
|
2.258 Liter (L)
Standard Deviation 0.76
|
2.222 Liter (L)
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: 52-week treatment periodPopulation: The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time).
Outcome measures
| Measure |
Symbicort SMART
n=1032 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
n=1026 Participants
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
|---|---|---|
|
Use of As-needed Medication
|
1.21 inhalations/day
Standard Deviation 1.39
|
1.46 inhalations/day
Standard Deviation 1.60
|
SECONDARY outcome
Timeframe: 52-week treatment periodPopulation: The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst).
Outcome measures
| Measure |
Symbicort SMART
n=1034 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
n=1025 Participants
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
|---|---|---|
|
Asthma Symptom Score
|
1.12 units on a scale
Standard Deviation 1.04
|
1.22 units on a scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: 52-week treatment periodPopulation: The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
The mean value from the treatment period was presented here.
Outcome measures
| Measure |
Symbicort SMART
n=1024 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
n=1025 Participants
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
|---|---|---|
|
Nights With Awakening(s) Due to Asthma Symptoms
|
15.7 Nights With Awakening(s)
Standard Deviation 27.1
|
17.5 Nights With Awakening(s)
Standard Deviation 27.2
|
SECONDARY outcome
Timeframe: up to 52 weeksPopulation: The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
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.
Outcome measures
| Measure |
Symbicort SMART
n=1049 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
n=1042 Participants
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
|---|---|---|
|
The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations
|
71 percentage of participants
|
80 percentage of participants
|
SECONDARY outcome
Timeframe: 52-week treatment periodPopulation: The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
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.
Outcome measures
| Measure |
Symbicort SMART
n=1034 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
n=1026 Participants
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
|---|---|---|
|
Symptom-free Days (no Symptoms and no Awakenings)
|
45.5 symptom-free days
Standard Deviation 37.8
|
41.6 symptom-free days
Standard Deviation 37.2
|
SECONDARY outcome
Timeframe: 52-week treatment periodPopulation: The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
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.
Outcome measures
| Measure |
Symbicort SMART
n=1032 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
n=1026 Participants
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
|---|---|---|
|
Percentage of As-needed-free Days
|
51.4 percentage of as-needed-free days
Standard Deviation 36.7
|
47.2 percentage of as-needed-free days
Standard Deviation 36.7
|
SECONDARY outcome
Timeframe: 52-week treatment periodPopulation: The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
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.
Outcome measures
| Measure |
Symbicort SMART
n=1033 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
n=1026 Participants
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
|---|---|---|
|
Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use)
|
41.7 percentage of asthma-control days
Standard Deviation 37.3
|
37.9 percentage of asthma-control days
Standard Deviation 36.6
|
SECONDARY outcome
Timeframe: 4, 12, 24, 36 and 52 weeks after randomizationPopulation: The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.
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.
Outcome measures
| Measure |
Symbicort SMART
n=1040 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
n=1038 Participants
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
|---|---|---|
|
Asthma Control Questionnaire (ACQ)
|
1.162 units on a scale
Standard Deviation 0.78
|
1.289 units on a scale
Standard Deviation 0.75
|
Adverse Events
Symbicort SMART
Symbicort+Terbutaline As Needed
Serious adverse events
| Measure |
Symbicort SMART
n=1049 participants at risk
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
n=1042 participants at risk
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Congenital, familial and genetic disorders
Cleft Lip
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Ear and labyrinth disorders
Meniere's Disease
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Endocrine disorders
Basedow's Disease
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Eye disorders
Cataract
|
0.10%
1/1049
|
0.10%
1/1042
|
|
Eye disorders
Retinal Detachment
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.29%
3/1049
|
0.00%
0/1042
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Gastrointestinal disorders
Acute Abdomen
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Gastrointestinal disorders
Anal Fissure
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Gastrointestinal disorders
Gastric Polyps
|
0.00%
0/1049
|
0.10%
1/1042
|
|
General disorders
Hernia Obstructive
|
0.10%
1/1049
|
0.00%
0/1042
|
|
General disorders
Malaise
|
0.00%
0/1049
|
0.10%
1/1042
|
|
General disorders
Pyrexia
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Infections and infestations
Pneumonia
|
0.38%
4/1049
|
0.19%
2/1042
|
|
Infections and infestations
Gastroenteritis
|
0.10%
1/1049
|
0.29%
3/1042
|
|
Infections and infestations
Tracheobronchitis
|
0.19%
2/1049
|
0.00%
0/1042
|
|
Infections and infestations
Upper Respiratory Tract Infection Bacterial
|
0.19%
2/1049
|
0.00%
0/1042
|
|
Infections and infestations
Acute Sinusitis
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Infections and infestations
Breast Abscess
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Infections and infestations
Bronchopneumonia
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Infections and infestations
H1n1 Influenza
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Infections and infestations
Lower Respiratory Tract Infection Bacterial
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Infections and infestations
Osteomyelitis
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Infections and infestations
Otitis Media Chronic
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Infections and infestations
Pneumonia Bacterial
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Infections and infestations
Septic Shock
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Infections and infestations
Urinary Tract Infection
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Infections and infestations
Varicella
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Infections and infestations
Viral Infection
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Injury, poisoning and procedural complications
Traumatic Brain Injury
|
0.00%
0/1049
|
0.19%
2/1042
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Injury, poisoning and procedural complications
Sternal Fracture
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/1049
|
0.19%
2/1042
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.19%
2/1049
|
0.00%
0/1042
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer In Situ
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal Adenocarcinoma
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Nervous system disorders
Convulsion
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Nervous system disorders
Syncope
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.10%
1/1049
|
0.10%
1/1042
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Threatened
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Pregnancy, puerperium and perinatal conditions
Premature Baby
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Psychiatric disorders
Major Depression
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Reproductive system and breast disorders
Breast Calcifications
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Reproductive system and breast disorders
Dysfunctional Uterine Bleeding
|
0.00%
0/1049
|
0.10%
1/1042
|
|
Reproductive system and breast disorders
Endometriosis
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Reproductive system and breast disorders
Infertility Male
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.48%
5/1049
|
3.0%
31/1042
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.10%
1/1049
|
0.19%
2/1042
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Septum Deviation
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.10%
1/1049
|
0.00%
0/1042
|
|
Vascular disorders
Hypertension
|
0.10%
1/1049
|
0.10%
1/1042
|
Other adverse events
| Measure |
Symbicort SMART
n=1049 participants at risk
Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
|
Symbicort+Terbutaline As Needed
n=1042 participants at risk
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
13.1%
137/1049
|
12.8%
133/1042
|
|
Infections and infestations
Bronchitis
|
6.6%
69/1049
|
7.4%
77/1042
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
5.7%
60/1049
|
6.9%
72/1042
|
|
Infections and infestations
Pharyngitis
|
4.7%
49/1049
|
5.6%
58/1042
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER