Local Phase 4 Pan-European SMART Study

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00463866
Collaborator
(none)
8,424
819
21.1
10.3
0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
8424 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Mar 1, 2007
Actual Study Completion Date :
Dec 1, 2008

Outcome Measures

Primary Outcome Measures

  1. Number of Severe Asthma Exacerbations Per Participant. [6 months]

    Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.

Secondary Outcome Measures

  1. Fraction of Participants With Severe Asthma Exacerbation [6 months.]

    The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.

  2. Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment. [6 months.]

    A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant

  3. Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation [6 months.]

    Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.

  4. Mean Daily Number of Inhalations of As-needed Medication. [4 weeks]

    The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.

  5. Percent of Participants With a Well Controlled Asthma Week. [6 months.]

    The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use.

  6. Mean Overall Asthma Control Questionnaire (ACQ) Score [6 months.]

    The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.

  7. The Mean Total Daily Dose of Steroids From Symbicort. [4 weeks]

    The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.

  8. Mean Cost Per Participant Per Country [6 months]

    Mean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients at out-patient clinics

  • 18 years with a minimum of 6 months documented history of persistent asthma who have used inhaled glucocorticosteroids for at least one month and have a history of use in rapid-acting B2 agonists for symptom relief

Exclusion Criteria:
  • Asthma exacerbation within the last 14 days prior to study start

  • subject aged >40 years with a smoking history of >10pack-years

  • subjects with chronic obstructive lung disease or other significant respiratory disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Aalst Belgium
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754 Research Site Cumbernauld United Kingdom
755 Research Site Darlington United Kingdom
756 Research Site Doncaste United Kingdom
757 Research Site Dumbarton United Kingdom
758 Research Site Dumfries United Kingdom
759 Research Site East Kilbride United Kingdom
760 Research Site Ecclwsfield United Kingdom
761 Research Site Ely United Kingdom
762 Research Site Fowey United Kingdom
763 Research Site Frome United Kingdom
764 Research Site Glasgow United Kingdom
765 Research Site Greenock United Kingdom
766 Research Site Hamilton United Kingdom
767 Research Site Headcorn United Kingdom
768 Research Site High Valleyfield United Kingdom
769 Research Site Huntington United Kingdom
770 Research Site Kirkintilloch United Kingdom
771 Research Site Larne United Kingdom
772 Research Site Leicester United Kingdom
773 Research Site Limavady United Kingdom
774 Research Site Lockerbie United Kingdom
775 Research Site London United Kingdom
776 Research Site Maidenhead United Kingdom
777 Research Site Manhester United Kingdom
778 Research Site Motherwell United Kingdom
779 Research Site New Stevenson United Kingdom
780 Research Site Newcastle United Kingdom
781 Research Site Newtonstewart United Kingdom
782 Research Site Newtownabbey United Kingdom
783 Research Site Northampton United Kingdom
784 Research Site Norwich United Kingdom
785 Research Site Nottingham United Kingdom
786 Research Site Nr Penzance United Kingdom
787 Research Site Paignton United Kingdom
788 Research Site Paisley United Kingdom
789 Research Site Penzance United Kingdom
790 Research Site Peterborough United Kingdom
791 Research Site Plymouth United Kingdom
792 Research Site Port Glasgow United Kingdom
793 Research Site Praze-on-Beeble United Kingdom
794 Research Site Reading United Kingdom
795 Research Site Reddich United Kingdom
796 Research Site Renfrew United Kingdom
797 Research Site Saltash United Kingdom
798 Research Site Sandy United Kingdom
799 Research Site Sheffield United Kingdom
800 Research Site Shepshed United Kingdom
801 Research Site Slough United Kingdom
802 Research Site Spalding United Kingdom
803 Research Site Spennymoor United Kingdom
804 Research Site Strathaven United Kingdom
805 Research Site Strathblane United Kingdom
806 Research Site Sunbury on Thames United Kingdom
807 Research Site Swindon United Kingdom
808 Research Site Thornhill United Kingdom
809 Research Site Thornton Heath United Kingdom
810 Research Site Tichfield United Kingdom
811 Research Site Torpoint United Kingdom
812 Research Site Trowbridge United Kingdom
813 Research Site Walsall United Kingdom
814 Research Site Welingborough United Kingdom
815 Research Site Wells next the sea United Kingdom
816 Research Site Weston-Super-Mare United Kingdom
817 Research Site Whitstable United Kingdom
818 Research Site Wishaw United Kingdom
819 Research Site Yaxley United Kingdom

Sponsors and Collaborators

  • AstraZeneca

Investigators

  • Principal Investigator: Michel Aubier, Prof, FRANCE
  • Study Chair: Juliette Ostinelli, MD, AstraZeneca, MC France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00463866
Other Study ID Numbers:
  • D5890L00022
  • EUROSMART
  • EudraCTNo. 2006-006512-30
First Posted:
Apr 20, 2007
Last Update Posted:
Mar 22, 2010
Last Verified:
Mar 1, 2010
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details This was a 6-month, randomised, open label, parallel-group, active controlled, multinational study, in participants with uncontrolled/partly controlled asthma, who were symptomatic despite daily use of inhaled glucocorticosteroid (IGCS) with or without Long-Acting β2 agonist (LABA).
Pre-assignment Detail
Arm/Group Title Symbicort® SMART®) 1*2 Symbicort® SMART®) 2*2
Arm/Group Description 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
Period Title: Overall Study
STARTED 4008 4045
COMPLETED 3699 3705
NOT COMPLETED 309 340

Baseline Characteristics

Arm/Group Title Symbicort® SMART®) 1*2 Symbicort® SMART®) 2*2 Total
Arm/Group Description 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed. Total of all reporting groups
Overall Participants 4008 4045 8053
Age (Years) [Mean (Full Range) ]
Mean (Full Range) [Years]
47.8
47.9
47.8
Sex: Female, Male (Count of Participants)
Female
2483
62%
2512
62.1%
4995
62%
Male
1525
38%
1533
37.9%
3058
38%
Treatment with Long-Acting β2 agonist (LABA) at baseline. (Number) [Number]
Number of participants using LABA at baseline.
3108
77.5%
3118
77.1%
6226
77.3%
Number of participants without LABA at baseline.
900
22.5%
927
22.9%
1827
22.7%
Asthma control questionnaire (ACQ5) score at study entry (Units on a scale) [Mean (Standard Deviation) ]
ACQ5 score at study entry
1.85
(0.98)
1.86
(1.01)
1.85
(0.99)
Exacerbations past 12 months before study start. (Number of exacerbations per participant) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Number of exacerbations per participant]
1.47
(2.42)
1.42
(2.42)
1.45
(2.42)
Inhaled glucocorticosteroids (IGCS) dose at study entry. (μg/day) [Mean (Standard Deviation) ]
IGCS dose at study entry
1046
(595)
1037
(575)
1042
(585)
Participants with a well controlled asthma week at study entry. (Percentage of participants) [Mean (Full Range) ]
Mean (Full Range) [Percentage of participants]
11.97
0.3%
11.77
0.3%
11.87
0.1%
Pulmonary function test at baseline. (Percent of predicted normal value of PEF) [Mean (Full Range) ]
Percent Included
90.8
90.1
90.4

Outcome Measures

1. Primary Outcome
Title Number of Severe Asthma Exacerbations Per Participant.
Description Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort® SMART®) 1*2 Symbicort® SMART®) 2*2
Arm/Group Description 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
Measure Participants 4008 4045
Mean (Full Range) [Severe exacerbations per participant]
0.097
(0)
0.080
(0)
2. Secondary Outcome
Title Fraction of Participants With Severe Asthma Exacerbation
Description The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
Time Frame 6 months.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort® SMART®) 1*2 Symbicort® SMART®) 2*2
Arm/Group Description 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
Measure Participants 4008 4045
Mean (95% Confidence Interval) [Fraction of participants with event]
0.09686
(0.08528) 0%
0.07955
(0.06927) 0%
3. Secondary Outcome
Title Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment.
Description A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant
Time Frame 6 months.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort® SMART®) 1*2 Symbicort® SMART®) 2*2
Arm/Group Description 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
Measure Participants 4008 4045
Mean (Full Range) [Number of events per participant]
0.0120
(0)
0.0091
(0)
4. Secondary Outcome
Title Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation
Description Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
Time Frame 6 months.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort® SMART®) 1*2 Symbicort® SMART®) 2*2
Arm/Group Description 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
Measure Participants 4008 4045
Mean (Standard Deviation) [Days per participant]
9.6
(8.1)
9.1
(5.5)
5. Secondary Outcome
Title Mean Daily Number of Inhalations of As-needed Medication.
Description The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.
Time Frame 4 weeks

Outcome Measure Data

Analysis Population Description
Inhalations of as-needed medication recorded by 3880 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3881 participants in the Symbicort SMART 2*2 Reporting Group
Arm/Group Title Symbicort® SMART®) 1*2 Symbicort® SMART®) 2*2
Arm/Group Description 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
Measure Participants 3880 3881
Mean (Full Range) [Inhalations per day per participant]
0.897
(0)
0.625
(0)
6. Secondary Outcome
Title Percent of Participants With a Well Controlled Asthma Week.
Description The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use.
Time Frame 6 months.

Outcome Measure Data

Analysis Population Description
Data for this measure recorded by 3714 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3718 participants in the Symbicort SMART 2*2 Reporting Group.
Arm/Group Title Symbicort® SMART®) 1*2 Symbicort® SMART®) 2*2
Arm/Group Description 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
Measure Participants 3714 3718
Mean (Full Range) [Percentage of participants]
43.69
(0) 1.1%
54.26
(0) 1.3%
7. Secondary Outcome
Title Mean Overall Asthma Control Questionnaire (ACQ) Score
Description The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.
Time Frame 6 months.

Outcome Measure Data

Analysis Population Description
Data for this measure recorded by 3709 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3735 participants in the Symbicort SMART 2*2 Reporting Group.
Arm/Group Title Symbicort® SMART®) 1*2 Symbicort® SMART®) 2*2
Arm/Group Description 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
Measure Participants 3709 3735
Mean (Full Range) [Scores in a scale]
1.18
(0)
1.089
(0)
8. Secondary Outcome
Title The Mean Total Daily Dose of Steroids From Symbicort.
Description The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.
Time Frame 4 weeks

Outcome Measure Data

Analysis Population Description
: Data for this measure recorded by 3874 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3873 participants in the Symbicort SMART 2*2 Reporting Group.
Arm/Group Title Symbicort® SMART®) 1*2 Symbicort® SMART®) 2*2
Arm/Group Description 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
Measure Participants 3874 3873
Mean (Standard Deviation) [μg budesonide per day]
462.96
(179.10)
736.58
(152.70)
9. Secondary Outcome
Title Mean Cost Per Participant Per Country
Description Mean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated.
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title Symbicort® SMART®) 1*2 Symbicort® SMART®) 2*2
Arm/Group Description 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
All Cause Mortality
Symbicort® SMART®) 1*2 Symbicort® SMART®) 2*2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Symbicort® SMART®) 1*2 Symbicort® SMART®) 2*2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 77/4008 (1.9%) 88/4045 (2.2%)
Blood and lymphatic system disorders
Anaemia 1/4008 (0%) 1/4045 (0%)
Cardiac disorders
Angina Pectoris 1/4008 (0%) 1/4045 (0%)
Atrial Fibrillation 2/4008 (0%) 1/4045 (0%)
Atrioventricular Block 1/4008 (0%) 0/4045 (0%)
Coronary Artery Disease 1/4008 (0%) 0/4045 (0%)
Myocardial Infarction 1/4008 (0%) 1/4045 (0%)
Tachyarrhythmia 1/4008 (0%) 0/4045 (0%)
Tachycardia 0/4008 (0%) 1/4045 (0%)
Congenital, familial and genetic disorders
Exomphalos 1/4008 (0%) 0/4045 (0%)
Ear and labyrinth disorders
Vertigo 1/4008 (0%) 0/4045 (0%)
Eye disorders
Cataract 0/4008 (0%) 2/4045 (0%)
Gastrointestinal disorders
Abdominal Pain 1/4008 (0%) 0/4045 (0%)
Abdominal Pain Lower 1/4008 (0%) 0/4045 (0%)
Colitis 2/4008 (0%) 0/4045 (0%)
Constipation 1/4008 (0%) 0/4045 (0%)
Crohn's Disease 1/4008 (0%) 0/4045 (0%)
Diarrhoea 2/4008 (0%) 0/4045 (0%)
Diverticulum Intestinal 0/4008 (0%) 1/4045 (0%)
Gastrointestinal Disorder 1/4008 (0%) 0/4045 (0%)
Inguinal Hernia 1/4008 (0%) 1/4045 (0%)
Pancreatitis 1/4008 (0%) 0/4045 (0%)
Pancreatitis Acute 1/4008 (0%) 0/4045 (0%)
Peritonitis 1/4008 (0%) 0/4045 (0%)
Reflux Oesophagitis 1/4008 (0%) 0/4045 (0%)
Salivary Gland Enlargement 0/4008 (0%) 1/4045 (0%)
Umbilical Hernia 1/4008 (0%) 1/4045 (0%)
Vomiting 1/4008 (0%) 0/4045 (0%)
General disorders
Chest Pain 2/4008 (0%) 1/4045 (0%)
Cyst 0/4008 (0%) 1/4045 (0%)
Death 1/4008 (0%) 1/4045 (0%)
Non-Cardiac Chest Pain 1/4008 (0%) 0/4045 (0%)
Pain 1/4008 (0%) 0/4045 (0%)
Hepatobiliary disorders
Cholecystitis 0/4008 (0%) 1/4045 (0%)
Cholecystitis Acute 0/4008 (0%) 1/4045 (0%)
Cholelithiasis 0/4008 (0%) 4/4045 (0.1%)
Immune system disorders
Food Allergy 0/4008 (0%) 1/4045 (0%)
Hypersensitivity 0/4008 (0%) 1/4045 (0%)
Sarcoidosis 0/4008 (0%) 1/4045 (0%)
Infections and infestations
Appendicitis 1/4008 (0%) 1/4045 (0%)
Bronchiectasis 1/4008 (0%) 0/4045 (0%)
Bronchitis 0/4008 (0%) 2/4045 (0%)
Campylobacter Gastroenteritis 1/4008 (0%) 0/4045 (0%)
Chronic Sinusitis 0/4008 (0%) 1/4045 (0%)
Epstein-Barr Virus Infection 0/4008 (0%) 1/4045 (0%)
Erysipelas 1/4008 (0%) 1/4045 (0%)
Gastroenteritis 1/4008 (0%) 1/4045 (0%)
Influenza 1/4008 (0%) 0/4045 (0%)
Lower Respiratory Tract Infection 1/4008 (0%) 1/4045 (0%)
Lung Infection 0/4008 (0%) 1/4045 (0%)
Meningitis Viral 0/4008 (0%) 1/4045 (0%)
Pilonidal Cyst 0/4008 (0%) 1/4045 (0%)
Pneumonia 3/4008 (0.1%) 3/4045 (0.1%)
Respiratory Tract Infection 1/4008 (0%) 0/4045 (0%)
Sinusitis 0/4008 (0%) 1/4045 (0%)
Tonsillitis 0/4008 (0%) 1/4045 (0%)
Tracheobronchitis 1/4008 (0%) 0/4045 (0%)
Injury, poisoning and procedural complications
Animal Bite 0/4008 (0%) 1/4045 (0%)
Ankle Fracture 1/4008 (0%) 0/4045 (0%)
Fall 1/4008 (0%) 1/4045 (0%)
Femur Fracture 1/4008 (0%) 0/4045 (0%)
Fibula Fracture 1/4008 (0%) 0/4045 (0%)
Joint Dislocation 1/4008 (0%) 1/4045 (0%)
Joint Injury 0/4008 (0%) 1/4045 (0%)
Ligament Rupture 1/4008 (0%) 0/4045 (0%)
Lower Limb Fracture 0/4008 (0%) 2/4045 (0%)
Meniscus Lesion 1/4008 (0%) 0/4045 (0%)
Multiple Drug Overdose 0/4008 (0%) 1/4045 (0%)
Overdose 0/4008 (0%) 1/4045 (0%)
Rib Fracture 0/4008 (0%) 1/4045 (0%)
Tibia Fracture 1/4008 (0%) 0/4045 (0%)
Traumatic Fracture 0/4008 (0%) 1/4045 (0%)
Upper Limb Fracture 1/4008 (0%) 1/4045 (0%)
Metabolism and nutrition disorders
Dehydration 0/4008 (0%) 1/4045 (0%)
Hypokalaemia 0/4008 (0%) 1/4045 (0%)
Type 2 Diabetes Mellitus 0/4008 (0%) 1/4045 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia 0/4008 (0%) 2/4045 (0%)
Fibromyalgia 0/4008 (0%) 1/4045 (0%)
Intervertebral Disc Protrusion 1/4008 (0%) 2/4045 (0%)
Muscle Mass 1/4008 (0%) 0/4045 (0%)
Muscle Spasms 0/4008 (0%) 1/4045 (0%)
Muscular Weakness 1/4008 (0%) 0/4045 (0%)
Osteoarthritis 3/4008 (0.1%) 3/4045 (0.1%)
Spinal Disorder 0/4008 (0%) 1/4045 (0%)
Tendonitis 1/4008 (0%) 0/4045 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma 0/4008 (0%) 1/4045 (0%)
Bladder Neoplasm 1/4008 (0%) 0/4045 (0%)
Breast Cancer 0/4008 (0%) 4/4045 (0.1%)
Metastases To Liver 0/4008 (0%) 1/4045 (0%)
Parathyroid Tumour Benign 0/4008 (0%) 1/4045 (0%)
Prostate Cancer 0/4008 (0%) 1/4045 (0%)
Uterine Leiomyoma 1/4008 (0%) 1/4045 (0%)
Vocal Cord Neoplasm 0/4008 (0%) 1/4045 (0%)
Nervous system disorders
Carotid Sinus Syndrome 1/4008 (0%) 0/4045 (0%)
Cerebrovascular Accident 1/4008 (0%) 2/4045 (0%)
Haemorrhage Intracranial 1/4008 (0%) 0/4045 (0%)
Haemorrhagic Stroke 1/4008 (0%) 0/4045 (0%)
Ischaemic Cerebral Infarction 1/4008 (0%) 0/4045 (0%)
Loss Of Consciousness 1/4008 (0%) 0/4045 (0%)
Migraine 1/4008 (0%) 0/4045 (0%)
Syncope 0/4008 (0%) 1/4045 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous 1/4008 (0%) 0/4045 (0%)
Reproductive system and breast disorders
Endometriosis 0/4008 (0%) 1/4045 (0%)
Menorrhagia 1/4008 (0%) 0/4045 (0%)
Vaginal Haemorrhage 1/4008 (0%) 0/4045 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma 13/4008 (0.3%) 9/4045 (0.2%)
Asthmatic Crisis 0/4008 (0%) 1/4045 (0%)
Chronic Obstructive Pulmonary Disease 0/4008 (0%) 1/4045 (0%)
Cough 0/4008 (0%) 1/4045 (0%)
Dyspnoea 1/4008 (0%) 2/4045 (0%)
Epistaxis 0/4008 (0%) 1/4045 (0%)
Pharyngeal Disorder 0/4008 (0%) 1/4045 (0%)
Pneumothorax 1/4008 (0%) 0/4045 (0%)
Pulmonary Embolism 0/4008 (0%) 2/4045 (0%)
Sleep Apnoea Syndrome 1/4008 (0%) 1/4045 (0%)
Vascular disorders
Deep Vein Thrombosis 1/4008 (0%) 0/4045 (0%)
Other (Not Including Serious) Adverse Events
Symbicort® SMART®) 1*2 Symbicort® SMART®) 2*2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/4008 (0%) 0/4045 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Results Point of Contact

Name/Title Gerard Lynch
Organization AstraZeneca
Phone
Email aztrial_results_posting@astrazeneca.com
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00463866
Other Study ID Numbers:
  • D5890L00022
  • EUROSMART
  • EudraCTNo. 2006-006512-30
First Posted:
Apr 20, 2007
Last Update Posted:
Mar 22, 2010
Last Verified:
Mar 1, 2010