Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004474-96 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to test if Symbicort® (budesonide/formoterol) Turbuhaler® is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort® 'as needed' will be compared with: 1) terbutaline Turbuhaler® 'as needed' and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline Turbuhaler® 'as needed'.
A 52-week, double-blind, randomised, multi-centre, parallel-group, Phase III study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort® (budesonide/formoterol) Turbuhaler® 160/4.5 μg 'as needed' compared with terbutaline Turbuhaler® 0.4 mg 'as needed' and with Pulmicort® (budesonide) Turbuhaler® 200 μg twice daily plus terbutaline Turbuhaler® 0.4 mg 'as needed'
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symbicort "as needed"+placebo Pulmicort bid | Experimental | Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' + Placebo Pulmicort Turbuhaler 200 μg bid |
|
| terbutaline "as needed"+placebo Pulmicort bid | Active Comparator | terbutaline Turbuhaler 0.4 mg 'as needed' + placebo Pulmicort 200 μg Turbuhaler bid |
|
| Pulmicort bid + terbutaline "as needed" | Active Comparator | Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed' |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide/formoterol 'as needed' + budesonide placebo bid | Drug | Symbicort (budesonide/ formoterol) 160/4.5 μg powder for inhalation 'as needed' plus Pulmicort placebo 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No) | A well-controlled asthma week is defined as the fulfilment of both conditions A) and B) below: A) Two or more of the following criteria are fulfilled: - No more than 2 days with a daily asthma symptom score >1 - No more than 2 days of 'as needed' medication use, up to a maximum of 4 occasions per week (multiple occasions per day should be regarded as separate occasions) - Morning PEF ≥80% of Predicted Normal every day B) Both of the following criteria are fulfilled: - No nighttime awakenings due to asthma - No additional inhaled and/or systemic glucocorticosteroid treatment due to asthma. The binary variable well-controlled asthma week was derived for each patient and study week. In addition, for each week, the percent of patients with well-controlled asthma week was derived. It is required that the eDiary had to be completed on at least 5 days in a week to be a well-controlled asthma week. | Weekly, up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing at Least One Severe Asthma Exacerbation | A severe exacerbation is defined as a deterioration of asthma requiring any of the following: use of systemic glucocorticosteroids (GCS) for at least 3 days, inpatient hospitalization, or emergency room visit due to asthma that required systemic steroids | Day 1 up to 52 weeks |
Not provided
INCLUSION CRITERIA 1. Provision of informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patient's parent/legal guardian is required 2. Male or Female, ≥12 years of age 3. Documented diagnosis of asthma for at least 6 months prior to Visit 1 4. Patients who are in need of Step 2 treatment according to Global Initiative for Asthma guidelines 5. Patients treated with 'as needed' inhaled short-acting bronchodilator(s) only should have pre-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥ 60 % of Predicted Normal (PN) and post-bronchodilator FEV1 ≥ 80 % PN 6. Patients treated with low stable dose of inhaled corticosteroid or leukotriene antagonist in addition to 'as needed' use of inhaled short-acting bronchodilator(s) should have pre-bronchodilator FEV1 ≥80 % PN 7. Patients should have reversible airway obstruction 8. To be randomized patients must have used Bricanyl Turbuhaler 'as needed' on at least 3 separate days during the last week of the run in period. EXCLUSION CRITERIA 1. Patient has a history of life-threatening asthma including intubation and intensive care unit admission 2. Patient has had an asthma worsening requiring change in treatment other than inhaled short-acting bronchodilator(s) within 30 days prior to Visit 1 or between Visits 1 and 2; or a treatment other than Bricanyl Turbuhaler from Visit 2 until randomization 3. Patient has required treatment with oral, rectal or parenteral glucocorticosteroids (GCS) within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1 4. Smoker (current or previous) with a smoking history of ≥ 10 pack years 5. Pregnancy, breast-feeding or planned pregnancy during the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul M O'Byrne, MB, FRCP(C), FRSC | McMaster University, Hamilton, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bedford Park | 5042 | Australia | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33548020 | Derived | FitzGerald JM, O'Byrne PM, Bateman ED, Barnes PJ, Zheng J, Ivanov S, Lamarca R, Larsdotter U, Emerath U, Jansen G, Puu M, Alagappan VKT, Surmont F, Reddel HK. Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies. Drug Saf. 2021 Apr;44(4):467-478. doi: 10.1007/s40264-020-01041-z. Epub 2021 Feb 6. | |
| 33010810 |
| Label | URL |
|---|---|
| D589SC00001-statistical-analysis-plan-edition-4\_29Sep2017\_pdfa | View source |
Not provided
Eligibility was assessed at Visits 1, 2, 3. IC obtained at V1. At V2, eligible patients stopped prescribed asthma medication and entered a 2-4 week run-in period, treated only with SABA Bricanyl Turbuhaler 0.5 mg, 'as needed'. Lung function was performed by spirometry to confirm eligibility. Eligible patients were randomised at Visit 3.
5721 patients enrolled; 5003 run-in, 718 not run-in; 3849 randomised, 1154 not randomised: 1022 did not meet incl/excl criteria, 4 adverse event, 5 severe non-compliance to protocol, 104 subject decision, 7 subject lost to follow-up, 12 other reason.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Bid + Symbicort 'as Needed' | Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg) |
| FG001 | Placebo Bid + Terbutaline 'as Needed' |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2017 | Apr 11, 2019 |
Not provided
Not provided
Not provided
Not provided
| terbutaline 'as needed' + placebo budesonide bid | Drug | Terbutaline 0.4 mg powder for inhalation 'as needed' plus placebo Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment |
|
| budesonide bid + terbutaline 'as needed' | Drug | Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment |
|
| Number of Participants Experiencing at Least One Moderate or Severe Asthma Exacerbation | A moderate exacerbation is defined as a deterioration of asthma requiring a change in treatment, i.e. initiation of prescribed additional ICS treatment to avoid progression of the worsening of asthma to a severe exacerbation. A severe exacerbation is defined as a deterioration of asthma requiring any of the following: use of systemic glucocorticosteroids (GCS) for at least 3 days, inpatient hospitalization, or emergency room visit due to asthma that required systemic steroids | Day 1 up to 52 weeks |
| Average Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) | Overall estimate of FEV1 (mL) pre-bronchodilator change from baseline. Baseline is the measurement at Visit 3 (prior to first dose of Investigational Product) from MMRM (mixed model repeated measures analysis). | Study weeks 0,4,16,28,40,52 |
| Average Change From Baseline in Morning Peak Expiratory Flow (PEF) | Morning peak expiratory flow (eDiary) change from baseline over the randomised treatment period. Baseline is defined as the mean of all non-missing morning measurements during the last 10 days of the run-in period. | up to 52 weeks |
| Average Change From Baseline in Evening PEF | Evening peak expiratory flow (eDiary) change from baseline during the randomised treatment period. Baseline is defined as the mean of all non-missing evening measurements during the last 10 days of the run-in period. | up to 52 weeks |
| Average Change From Baseline in Number of Inhalations of 'as Needed' Medication. | 'As needed' inhalations change from baseline over the randomised treatment period. Baseline is defined as the last 10 days of the run-in period. 'As needed' use was calculated as the cumulative doses of 'as needed' medication over the randomised treatment period divided by the follow-up time (number of days - 1). ie, average number of inhalations per day. | up to 52 weeks |
| Average Change From Baseline in Asthma Symptom Score | Asthma symptom score (eDiary) change from baseline during the randomised treatment period. Symptom score is entered morning and evening by the patient on a 4-point scale from 0 to 3 with higher values indicating more severe symptoms. Asthma symptom score is then the sum of the day and night scores, which implies a range of scores from 0 - 6, with higher values indicating more severe symptoms. Baseline is defined as the mean of all non-missing measurements during the last 10 days of the run-in period. | up to 52 weeks |
| Change From Baseline in the Percentage of Nighttime Awakenings Due to Asthma | Night-time awakenings (%) due to asthma change from baseline. Variable analysed is the proportion (%) of nights during the relevant period with night-time awakenings. Baseline refers to the last 10 nights of the run-in period. | up to 52 weeks |
| Change From Baseline in Percentage of Symptom-free Days | Symptom-free days (%) change from baseline during the randomised treatment period.Variable analysed is the proportion (%) of symptom-free days during the relevant period. Baseline refers to the last 10 days of the run-in period. | up to 52 weeks |
| Change From Baseline in Percentage of 'As Needed' Free Days | 'As needed' free days (%) change from baseline during the randomised treatment period. An 'as needed' free day is defined as a day and night with no use of 'as needed' medication. Variable analysed is the proportion (%) of 'as needed' free days during the relevant period. Baseline refers to the last 10 days of the run-in period. | up to 52 weeks |
| Change From Baseline in Percentage of Asthma Control Days | Asthma control days (%) change from baseline. An asthma control day is defined as the fulfilment of all of the following criteria; a day and night with no asthma symptoms, a night with no awakenings due to asthma symptoms and a day and night with no use of 'as needed' medication. Variable analysed is the proportion (%) of asthma control days during the randomised treatment period. Baseline refers to the last 10 days of the run-in period. | up to 52 weeks |
| Number of Patients With Study Specific Asthma Related Discontinuation | Study specific asthma related discontinuation | up to 52 weeks |
| Poorly Controlled Asthma Weeks | A poorly-controlled asthma week is defined as a week meeting any one of the following conditions: Two or more consecutive days with awakenings due to asthma on both nights; A recorded use of 'as needed' medication for symptom relief of at least 3 occasions per day, for at least 2 consecutive days; Additional systemic GCS treatment required for severe exacerbation. If there were sufficient data within a week available to confirm the week was not poorly-controlled, the week is labelled as 'does not meet criteria for poorly-controlled'. | Weekly for up to 52 weeks |
| Number of Participants Experiencing at Least One Occasion With Additional Steroids for Asthma | Additional steroids for asthma includes any additional inhaled and/or systemic glucocorticosteroids treatment due to asthma while in the randomised treatment period. | Day 1 up to 52 weeks |
| Average Change From Baseline in Asthma Control Questionnaire (ACQ-5) | Asthma Control Questionnaire 5-item version score change from baseline. ACQ questionnaire contains five questions on patients' symptoms, which are assessed on a 7-point scale from 0 (representing good control) to 6 (representing poor control). The score is the mean score of all questions for which responses are provided. | Study weeks 0,4,16,28,40,52 |
| Average Change From Baseline in Asthma Quality of Life Questionnaire; Standard Version (AQLQ(S)) | Asthma Quality of Life Questionnaire Standardised Version (AQLQ (S) overall score change from baseline. AQLQ(S) consists of 32 questions in 4 domains. Each question is assessed on a 7-point scale from 1 to 7, with higher values indicating better health-related quality of life. The overall score is calculated as the mean score of all 32 items. | Study weeks 0,16,28,40,52 |
| Percentage of Controller Use Days | ICS controller use days (%) during the randomised treatment period is calculated as the cumulative number of days when any controller medication (containing ICS) was taken including maintenance (Pulmicort bid group) and 'as needed' medication (Symbicort 'as needed' group) and additional prescribed ICS for asthma exacerbations and/or long term poor asthma control (all treatment groups), divided by the number of days in the randomised treatment period. | up to 52 weeks |
| Annual Severe Asthma Exacerbation Rate | Severe asthma exacerbations over the randomised treatment period. | up to 52 weeks |
| Annual Moderate or Severe Asthma Exacerbation Rate | Moderate or severe asthma exacerbations during the randomised treatment period. | up to 52 weeks |
| Concord |
| 2139 |
| Australia |
| Research Site | Maroubra | 2035 | Australia |
| Research Site | Murdoch | 6150 | Australia |
| Research Site | Wollongong | 2522 | Australia |
| Research Site | Alphaville | 06454-010 | Brazil |
| Research Site | Botucatu | 18618-970 | Brazil |
| Research Site | Porto Alegre | 90020-060 | Brazil |
| Research Site | Porto Alegre | 90470-340 | Brazil |
| Research Site | Porto Alegre | 90610-000 | Brazil |
| Research Site | Salvador | 41940-455 | Brazil |
| Research Site | Santo André | 09080-110 | Brazil |
| Research Site | São Paulo | 04020-060 | Brazil |
| Research Site | São Paulo | 04101-000 | Brazil |
| Research Site | Sorocaba | 18040-425 | Brazil |
| Research Site | Dupnitsa | 2600 | Bulgaria |
| Research Site | Gotse Delchev | 2900 | Bulgaria |
| Research Site | Kozloduy | 3320 | Bulgaria |
| Research Site | Pazardzhik | 4400 | Bulgaria |
| Research Site | Plovdiv | 4002 | Bulgaria |
| Research Site | Razgrad | 7200 | Bulgaria |
| Research Site | Roman | 3130 | Bulgaria |
| Research Site | Rousse | 7002 | Bulgaria |
| Research Site | Sandanski | 2800 | Bulgaria |
| Research Site | Sofia | 1000 | Bulgaria |
| Research Site | Sofia | 1152 | Bulgaria |
| Research Site | Sofia | 1431 | Bulgaria |
| Research Site | Sofia | 1606 | Bulgaria |
| Research Site | Sofia | 1618 | Bulgaria |
| Research Site | Varna | 9000 | Bulgaria |
| Research Site | Velingrad | 4600 | Bulgaria |
| Research Site | Vratsa | 3000 | Bulgaria |
| Research Site | Edmonton | Alberta | T5A 4L8 | Canada |
| Research Site | Sherwood Park | Alberta | T8L 0N2 | Canada |
| Research Site | Maple Ridge | British Columbia | V2X 2L5 | Canada |
| Research Site | North Vancouver | British Columbia | V7M 2H9 | Canada |
| Research Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Research Site | Mount Pearl | Newfoundland and Labrador | A1N 1W7 | Canada |
| Research Site | St. John's | Newfoundland and Labrador | A1A 3R5 | Canada |
| Research Site | Ajax | Ontario | L1S 2J5 | Canada |
| Research Site | Burlington | Ontario | L7N 3V2 | Canada |
| Research Site | Cornwall | Ontario | K6H 4M4 | Canada |
| Research Site | Etobicoke | Ontario | M9W 4L6 | Canada |
| Research Site | Hamilton | Ontario | L8N 4A6 | Canada |
| Research Site | Kanata | Ontario | K2L 3C8 | Canada |
| Research Site | London | Ontario | N6H 0G6 | Canada |
| Research Site | Mississauga | Ontario | L5A 3V4 | Canada |
| Research Site | Newmarket | Ontario | L3Y 5G8 | Canada |
| Research Site | North York | Ontario | M3M 3E5 | Canada |
| Research Site | Ottawa | Ontario | K2H 8T5 | Canada |
| Research Site | Sarnia | Ontario | N7T 4X3 | Canada |
| Research Site | Toronto | Ontario | M9C 4Z5 | Canada |
| Research Site | Toronto | Ontario | M9V 4B4 | Canada |
| Research Site | Windsor | Ontario | N8X 2G1 | Canada |
| Research Site | Lévis | Quebec | G6W 0M5 | Canada |
| Research Site | Montreal | Quebec | H1M 1B1 | Canada |
| Research Site | Montreal | Quebec | H3G 1L5 | Canada |
| Research Site | Montreal | Quebec | H4J 1C5 | Canada |
| Research Site | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| Research Site | Québec | Quebec | G1G 3Y8 | Canada |
| Research Site | Québec | Quebec | G1V 4W2 | Canada |
| Research Site | Québec | Quebec | G1W 4R4 | Canada |
| Research Site | Québec | Quebec | G2J 0C4 | Canada |
| Research Site | Saint-Charles-Borromée | Quebec | J6E 2B4 | Canada |
| Research Site | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| Research Site | Victoriaville | Quebec | G6P 6P6 | Canada |
| Research Site | Quillota | 2260000 | Chile |
| Research Site | Santiago | 404366 | Chile |
| Research Site | Santiago | 7750495 | Chile |
| Research Site | Santiago | 7980378 | Chile |
| Research Site | Santiago | 8380453 | Chile |
| Research Site | Talcahuano | 4270918 | Chile |
| Research Site | Beijing | 100043 | China |
| Research Site | Beijing | 100050 | China |
| Research Site | Changsha | 430033 | China |
| Research Site | Chengdu | 610041 | China |
| Research Site | Chengdu | 610083 | China |
| Research Site | Guangzhou | 510120 | China |
| Research Site | Guangzhou | 510515 | China |
| Research Site | Haikou | 570311 | China |
| Research Site | Hohhot | 010017 | China |
| Research Site | Nanchang | 330006 | China |
| Research Site | Shanghai | 200000 | China |
| Research Site | Shanghai | 200032 | China |
| Research Site | Shanghai | 200040 | China |
| Research Site | Shanghai | 200120 | China |
| Research Site | Shanghai | 200240 | China |
| Research Site | Shanghai | 200433 | China |
| Research Site | Shenyang | 110015 | China |
| Research Site | Wenzhou | 325027 | China |
| Research Site | Wuhan | CN-430030 | China |
| Research Site | Xi'an | 710004 | China |
| Research Site | Xi'an | 710038 | China |
| Research Site | Xiamen | 361004 | China |
| Research Site | Xuzhou | 221006 | China |
| Research Site | Balassagyarmat | 2660 | Hungary |
| Research Site | Berettyóújfalu | 4100 | Hungary |
| Research Site | Budapest | 1195 | Hungary |
| Research Site | Budapest | 1204 | Hungary |
| Research Site | Edelény | 3780 | Hungary |
| Research Site | Hajdúnánás | 4080 | Hungary |
| Research Site | Mátészalka | 4700 | Hungary |
| Research Site | Miskolc | 3529 | Hungary |
| Research Site | Monor | 2200 | Hungary |
| Research Site | Nyírbátor | 4300 | Hungary |
| Research Site | Nyíregyháza | 4420 | Hungary |
| Research Site | Pécs | 7626 | Hungary |
| Research Site | Pécs | 7635 | Hungary |
| Research Site | Szeged | H-6722 | Hungary |
| Research Site | D.F. | 03020 | Mexico |
| Research Site | Durango | 43080 | Mexico |
| Research Site | México | 04530 | Mexico |
| Research Site | México | 06700 | Mexico |
| Research Site | México | 06720 | Mexico |
| Research Site | Monterrey | 64461 | Mexico |
| Research Site | Morelia | 58070 | Mexico |
| Research Site | Villahermosa | 86035 | Mexico |
| Research Site | Cusco | CUSCO 01 | Peru |
| Research Site | Lima | 41 | Peru |
| Research Site | Lima | L18 | Peru |
| Research Site | Lima | L27 | Peru |
| Research Site | Lima | LIMA 1 | Peru |
| Research Site | Lima | LIMA 31 | Peru |
| Research Site | Lima | LIMA 41 | Peru |
| Research Site | Piura | Peru |
| Research Site | Surco | LIMA 33 | Peru |
| Research Site | Lipa City | 4217 | Philippines |
| Research Site | Manila | 1000 | Philippines |
| Research Site | Manila | 1003 | Philippines |
| Research Site | Pasig | 1000 | Philippines |
| Research Site | Quezon City | 1101 | Philippines |
| Research Site | Bialystok | 15-003 | Poland |
| Research Site | Bialystok | 15-430 | Poland |
| Research Site | Elblag | 82-300 | Poland |
| Research Site | Grodzisk Mazowiecki | 05-825 | Poland |
| Research Site | Grudziądz | 86-300 | Poland |
| Research Site | Kielce | 25-734 | Poland |
| Research Site | Krakow | 30-901 | Poland |
| Research Site | Krakow | 31-011 | Poland |
| Research Site | Krakow | 31-209 | Poland |
| Research Site | Krakow | 31-455 | Poland |
| Research Site | Lodz | 90-141 | Poland |
| Research Site | Lodz | 90-203 | Poland |
| Research Site | Lodz | 91-103 | Poland |
| Research Site | Poznan | 60-685 | Poland |
| Research Site | Poznan | 60-823 | Poland |
| Research Site | Rzeszów | 35-051 | Poland |
| Research Site | Rzeszów | 35-612 | Poland |
| Research Site | Skierniewice | 96-100 | Poland |
| Research Site | Strzelce Opolskie | 47-100 | Poland |
| Research Site | Szczecin | 70-111 | Poland |
| Research Site | Szczecin | 71-124 | Poland |
| Research Site | Słupca | 62-400 | Poland |
| Research Site | Tarnów | 33-100 | Poland |
| Research Site | Trzebnica | 55-100 | Poland |
| Research Site | Turek | 62-700 | Poland |
| Research Site | Zabrze | 41-800 | Poland |
| Research Site | Bragadiru | 077025 | Romania |
| Research Site | Brasov | 500051 | Romania |
| Research Site | Brasov | 500283 | Romania |
| Research Site | Cluj-Napoca | 400371 | Romania |
| Research Site | Constanța | 900002 | Romania |
| Research Site | Piteşti | 110084 | Romania |
| Research Site | Timișoara | 300310 | Romania |
| Research Site | Chelyabinsk | 454021 | Russia |
| Research Site | Gatchina | 188300 | Russia |
| Research Site | Ivanovo | 153005 | Russia |
| Research Site | Kazan' | 420012 | Russia |
| Research Site | Kemerovo | 650002 | Russia |
| Research Site | Kemerovo | 650099 | Russia |
| Research Site | Krasnoyarsk | 660022 | Russia |
| Research Site | Moscow | 105077 | Russia |
| Research Site | Moscow | 109240 | Russia |
| Research Site | Moscow | 117630 | Russia |
| Research Site | Moscow | 119992 | Russia |
| Research Site | Moscow | 123995 | Russia |
| Research Site | Moscow | 127018 | Russia |
| Research Site | Moscow | 142160 | Russia |
| Research Site | Nizhny Novgorod | 603126 | Russia |
| Research Site | Novosibirsk | 630008 | Russia |
| Research Site | Novosibirsk | 630084 | Russia |
| Research Site | Penza | 440067 | Russia |
| Research Site | Perm | 614056 | Russia |
| Research Site | Perm | 6144090 | Russia |
| Research Site | Petrozavodsk | 185019 | Russia |
| Research Site | Pyatigorsk | 357538 | Russia |
| Research Site | Ryazan | 390026 | Russia |
| Research Site | Saint Petersburg | 193312 | Russia |
| Research Site | Saint Petersburg | 194100 | Russia |
| Research Site | Saint Petersburg | 194354 | Russia |
| Research Site | Saint Petersburg | 196084 | Russia |
| Research Site | Saint Petersburg | 196211 | Russia |
| Research Site | Saint Petersburg | 196657 | Russia |
| Research Site | Saint Petersburg | 197022 | Russia |
| Research Site | Saratov | 410012 | Russia |
| Research Site | Ulyanovsk | 432009 | Russia |
| Research Site | Vladikavkaz | 362007 | Russia |
| Research Site | Volgograd | 400001 | Russia |
| Research Site | Volgograd | 400131 | Russia |
| Research Site | Voronezh | 394066 | Russia |
| Research Site | Yaroslavl | 150002 | Russia |
| Research Site | Yaroslavl | 150003 | Russia |
| Research Site | Yekaterinburg | 620039 | Russia |
| Research Site | Yekaterinburg | 620109 | Russia |
| Research Site | Yekaterinburg | 620219 | Russia |
| Research Site | Boksburg North | 1460 | South Africa |
| Research Site | Durban | 4001 | South Africa |
| Research Site | Durban | 4037 | South Africa |
| Research Site | Durban | 4170 | South Africa |
| Research Site | Johannesburg | 1818 | South Africa |
| Research Site | Johannesburg | 2001 | South Africa |
| Research Site | KwaDukuza | 4450 | South Africa |
| Research Site | Middelburg | 1055 | South Africa |
| Research Site | Queenswood | South Africa |
| Research Site | Verulam | 4345 | South Africa |
| Research Site | Bucheon-si | 14584 | South Korea |
| Research Site | Cheongju-si | 28644 | South Korea |
| Research Site | Cheongju-si | 362-804 | South Korea |
| Research Site | Incheon | 21431 | South Korea |
| Research Site | Seoul | 03181 | South Korea |
| Research Site | Seoul | 03312 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 06591 | South Korea |
| Research Site | Seoul | 07985 | South Korea |
| Research Site | Seoul | 110-744 | South Korea |
| Research Site | Cherkasy | 18009 | Ukraine |
| Research Site | Dnipropetrovsk | 49074 | Ukraine |
| Research Site | Ivano-Frankivsk | 76012 | Ukraine |
| Research Site | Kharkiv | 61002 | Ukraine |
| Research Site | Kharkiv | 61035 | Ukraine |
| Research Site | Kharkiv | 61039 | Ukraine |
| Research Site | Kharkiv | 61058 | Ukraine |
| Research Site | Kharkiv | 61075 | Ukraine |
| Research Site | Kharkiv | 61093 | Ukraine |
| Research Site | Kyiv | 03049 | Ukraine |
| Research Site | Kyiv | 03680 | Ukraine |
| Research Site | Kyiv | Ukraine |
| Research Site | Lutsk | 43000 | Ukraine |
| Research Site | Lutsk | 43024 | Ukraine |
| Research Site | Lviv | 79066 | Ukraine |
| Research Site | Odesa | 65025 | Ukraine |
| Research Site | Vinnytsia | 21018 | Ukraine |
| Research Site | Zaporizhzhya | 69068 | Ukraine |
| Research Site | Bath | BA3 2UH | United Kingdom |
| Research Site | Coventry | CV6 4DD | United Kingdom |
| Research Site | Mortimer Reading | RG7 3SQ | United Kingdom |
| Research Site | Royal Leamington Spa | CV32 4RA | United Kingdom |
| Research Site | Trowbridge | BA14 8QA | United Kingdom |
| Research Site | Haiphong | 180000 | Vietnam |
| Research Site | Hanoi | 100000 | Vietnam |
| Research Site | Ho Chi Minh City | 700000 | Vietnam |
| Research Site | Ho Chi Minh City | Vietnam |
| Research Site | Hochiminh | Vietnam |
| Research Site | Đông Nãi | 810000 | Vietnam |
| O'Byrne PM, FitzGerald JM, Bateman ED, Barnes PJ, Zheng J, Gustafson P, Lamarca R, Puu M, Keen C, Alagappan VKT, Reddel HK. Effect of a single day of increased as-needed budesonide-formoterol use on short-term risk of severe exacerbations in patients with mild asthma: a post-hoc analysis of the SYGMA 1 study. Lancet Respir Med. 2021 Feb;9(2):149-158. doi: 10.1016/S2213-2600(20)30416-1. Epub 2020 Oct 1. |
| 29768149 | Derived | O'Byrne PM, FitzGerald JM, Bateman ED, Barnes PJ, Zhong N, Keen C, Jorup C, Lamarca R, Ivanov S, Reddel HK. Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma. N Engl J Med. 2018 May 17;378(20):1865-1876. doi: 10.1056/NEJMoa1715274. |
| 28069068 | Derived | O'Byrne PM, FitzGerald JM, Zhong N, Bateman E, Barnes PJ, Keen C, Almqvist G, Pemberton K, Jorup C, Ivanov S, Reddel HK. The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given 'as needed' in mild asthma: study protocols for two randomised controlled trials. Trials. 2017 Jan 10;18(1):12. doi: 10.1186/s13063-016-1731-4. |
| 27912982 | Derived | Reddel HK, Busse WW, Pedersen S, Tan WC, Chen YZ, Jorup C, Lythgoe D, O'Byrne PM. Should recommendations about starting inhaled corticosteroid treatment for mild asthma be based on symptom frequency: a post-hoc efficacy analysis of the START study. Lancet. 2017 Jan 14;389(10065):157-166. doi: 10.1016/S0140-6736(16)31399-X. Epub 2016 Nov 30. |
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
| FG002 | Pulmicort Bid + Terbutaline 'as Needed' | Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed' |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set includes all patients randomised and receiving any IP.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Bid + Symbicort 'as Needed' | Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg) |
| BG001 | Placebo Bid + Terbutaline 'as Needed' | Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed' |
| BG002 | Pulmicort Bid + Terbutaline 'as Needed' | Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed' |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age is being measured in years | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Full Analysis Set | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No) | A well-controlled asthma week is defined as the fulfilment of both conditions A) and B) below: A) Two or more of the following criteria are fulfilled: - No more than 2 days with a daily asthma symptom score >1 - No more than 2 days of 'as needed' medication use, up to a maximum of 4 occasions per week (multiple occasions per day should be regarded as separate occasions) - Morning PEF ≥80% of Predicted Normal every day B) Both of the following criteria are fulfilled: - No nighttime awakenings due to asthma - No additional inhaled and/or systemic glucocorticosteroid treatment due to asthma. The binary variable well-controlled asthma week was derived for each patient and study week. In addition, for each week, the percent of patients with well-controlled asthma week was derived. It is required that the eDiary had to be completed on at least 5 days in a week to be a well-controlled asthma week. | Full analysis set. Patients with no evaluable weeks are not included in the analysis. | Posted | Mean | Standard Deviation | Percentage | Weekly, up to 52 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing at Least One Severe Asthma Exacerbation | A severe exacerbation is defined as a deterioration of asthma requiring any of the following: use of systemic glucocorticosteroids (GCS) for at least 3 days, inpatient hospitalization, or emergency room visit due to asthma that required systemic steroids | Full analysis set | Posted | Number | Participants | Day 1 up to 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing at Least One Moderate or Severe Asthma Exacerbation | A moderate exacerbation is defined as a deterioration of asthma requiring a change in treatment, i.e. initiation of prescribed additional ICS treatment to avoid progression of the worsening of asthma to a severe exacerbation. A severe exacerbation is defined as a deterioration of asthma requiring any of the following: use of systemic glucocorticosteroids (GCS) for at least 3 days, inpatient hospitalization, or emergency room visit due to asthma that required systemic steroids | Full analysis set | Posted | Number | Participants | Day 1 up to 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) | Overall estimate of FEV1 (mL) pre-bronchodilator change from baseline. Baseline is the measurement at Visit 3 (prior to first dose of Investigational Product) from MMRM (mixed model repeated measures analysis). | Full analysis set. | Posted | Least Squares Mean | 95% Confidence Interval | mL | Study weeks 0,4,16,28,40,52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Change From Baseline in Morning Peak Expiratory Flow (PEF) | Morning peak expiratory flow (eDiary) change from baseline over the randomised treatment period. Baseline is defined as the mean of all non-missing morning measurements during the last 10 days of the run-in period. | Full analysis set. | Posted | Least Squares Mean | 95% Confidence Interval | L/min | up to 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Change From Baseline in Evening PEF | Evening peak expiratory flow (eDiary) change from baseline during the randomised treatment period. Baseline is defined as the mean of all non-missing evening measurements during the last 10 days of the run-in period. | Full analysis set | Posted | Least Squares Mean | 95% Confidence Interval | L/min | up to 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Change From Baseline in Number of Inhalations of 'as Needed' Medication. | 'As needed' inhalations change from baseline over the randomised treatment period. Baseline is defined as the last 10 days of the run-in period. 'As needed' use was calculated as the cumulative doses of 'as needed' medication over the randomised treatment period divided by the follow-up time (number of days - 1). ie, average number of inhalations per day. | Full analysis set. | Posted | Mean | Standard Deviation | Number of inhalations per day | up to 52 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Change From Baseline in Asthma Symptom Score | Asthma symptom score (eDiary) change from baseline during the randomised treatment period. Symptom score is entered morning and evening by the patient on a 4-point scale from 0 to 3 with higher values indicating more severe symptoms. Asthma symptom score is then the sum of the day and night scores, which implies a range of scores from 0 - 6, with higher values indicating more severe symptoms. Baseline is defined as the mean of all non-missing measurements during the last 10 days of the run-in period. | Full analysis set | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | up to 52 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Percentage of Nighttime Awakenings Due to Asthma | Night-time awakenings (%) due to asthma change from baseline. Variable analysed is the proportion (%) of nights during the relevant period with night-time awakenings. Baseline refers to the last 10 nights of the run-in period. | Full analysis set. | Posted | Mean | Standard Deviation | % of nights | up to 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Percentage of Symptom-free Days | Symptom-free days (%) change from baseline during the randomised treatment period.Variable analysed is the proportion (%) of symptom-free days during the relevant period. Baseline refers to the last 10 days of the run-in period. | Full analysis set | Posted | Mean | Standard Deviation | % of days | up to 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Percentage of 'As Needed' Free Days | 'As needed' free days (%) change from baseline during the randomised treatment period. An 'as needed' free day is defined as a day and night with no use of 'as needed' medication. Variable analysed is the proportion (%) of 'as needed' free days during the relevant period. Baseline refers to the last 10 days of the run-in period. | Full analysis set | Posted | Mean | Standard Deviation | % of days | up to 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Percentage of Asthma Control Days | Asthma control days (%) change from baseline. An asthma control day is defined as the fulfilment of all of the following criteria; a day and night with no asthma symptoms, a night with no awakenings due to asthma symptoms and a day and night with no use of 'as needed' medication. Variable analysed is the proportion (%) of asthma control days during the randomised treatment period. Baseline refers to the last 10 days of the run-in period. | Full analysis set | Posted | Mean | Standard Deviation | % of days | up to 52 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Study Specific Asthma Related Discontinuation | Study specific asthma related discontinuation | Full Analysis Set | Posted | Number | Participants | up to 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Poorly Controlled Asthma Weeks | A poorly-controlled asthma week is defined as a week meeting any one of the following conditions: Two or more consecutive days with awakenings due to asthma on both nights; A recorded use of 'as needed' medication for symptom relief of at least 3 occasions per day, for at least 2 consecutive days; Additional systemic GCS treatment required for severe exacerbation. If there were sufficient data within a week available to confirm the week was not poorly-controlled, the week is labelled as 'does not meet criteria for poorly-controlled'. | Full analysis set | Posted | Mean | Standard Deviation | weeks | Weekly for up to 52 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing at Least One Occasion With Additional Steroids for Asthma | Additional steroids for asthma includes any additional inhaled and/or systemic glucocorticosteroids treatment due to asthma while in the randomised treatment period. | Full analysis set | Posted | Number | Participants | Day 1 up to 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Change From Baseline in Asthma Control Questionnaire (ACQ-5) | Asthma Control Questionnaire 5-item version score change from baseline. ACQ questionnaire contains five questions on patients' symptoms, which are assessed on a 7-point scale from 0 (representing good control) to 6 (representing poor control). The score is the mean score of all questions for which responses are provided. | Full analysis set. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Study weeks 0,4,16,28,40,52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Change From Baseline in Asthma Quality of Life Questionnaire; Standard Version (AQLQ(S)) | Asthma Quality of Life Questionnaire Standardised Version (AQLQ (S) overall score change from baseline. AQLQ(S) consists of 32 questions in 4 domains. Each question is assessed on a 7-point scale from 1 to 7, with higher values indicating better health-related quality of life. The overall score is calculated as the mean score of all 32 items. | Full analysis set. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Study weeks 0,16,28,40,52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Controller Use Days | ICS controller use days (%) during the randomised treatment period is calculated as the cumulative number of days when any controller medication (containing ICS) was taken including maintenance (Pulmicort bid group) and 'as needed' medication (Symbicort 'as needed' group) and additional prescribed ICS for asthma exacerbations and/or long term poor asthma control (all treatment groups), divided by the number of days in the randomised treatment period. | Full analysis set. | Posted | Mean | Standard Deviation | % of days | up to 52 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Annual Severe Asthma Exacerbation Rate | Severe asthma exacerbations over the randomised treatment period. | Full analysis set | Posted | Least Squares Mean | 95% Confidence Interval | exacerbations per year | up to 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Annual Moderate or Severe Asthma Exacerbation Rate | Moderate or severe asthma exacerbations during the randomised treatment period. | Full analysis set | Posted | Least Squares Mean | 95% Confidence Interval | exacerbations per year | up to 52 weeks |
|
|
Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Bid + Symbicort 'as Needed' | Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg) | 0 | 1,277 | 38 | 1,277 | 295 | 1,277 |
| EG001 | Placebo Bid + Terbutaline 'as Needed' | Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed' | 0 | 1,277 | 50 | 1,277 | 378 | 1,277 |
| EG002 | Pulmicort Bid + Terbutaline 'as Needed' | Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed' | 2 | 1,282 | 37 | 1,282 | 360 | 1,282 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abcess intestinal | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Atypical mycobacterial pneumonia | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Keratitis viral | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Peritoneal abscess | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Tonsillitis bacterial | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.0 | Systematic Assessment |
| |
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.0 | Systematic Assessment |
| |
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.0 | Systematic Assessment |
| |
| Uterine leimyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Adjustment disorder | Psychiatric disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Amaurosis | Eye disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Hernial eventration | Gastrointestinal disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Gallbladder polyp | Hepatobiliary disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Chrondropathy | Musculoskeletal and connective tissue disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Nephrolothiasis | Renal and urinary disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Obstructive uropathy | Renal and urinary disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA version 20.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA version 20.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA version 20.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 20.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA version 20.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA version 20.0 | Systematic Assessment |
| |
| Intervertebral disc injury | Injury, poisoning and procedural complications | MedDRA version 20.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA version 20.0 | Systematic Assessment |
| |
| Lumbar limb fracture | Injury, poisoning and procedural complications | MedDRA version 20.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA version 20.0 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA version 20.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA version 20.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA version 20.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA version 20.0 | Systematic Assessment |
| |
| Patient-device incompatibility | Product Issues | MedDRA version 20.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 20.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stefan Ivanov | AstraZeneca AB | 000000000000 | information.center@astrazeneca.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 22, 2016 | Nov 4, 2019 | Prot_002.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| >=18 - <50 |
|
| >=50 - <65 |
|
| >=65 - <85 |
|
| >=85 |
|
| Male |
|
| Asian |
|
| Native Hawaiian Or Other Pacific Islander |
|
| Black Or African American |
|
| White |
|
| Other |
|
| Regression, Logistic |
Repeated measures logistic regression with treatment, pre-study treatment, region and study week as fixed effects. |
| Odds Ratio (OR) |
| 0.64 |
| 2-Sided |
| 95 |
| 0.57 |
| 0.73 |
| Non-Inferiority |
Non-inferiority analysis based on CI instead of p-value, hence no p-value calculated for this analysis. Lower limit of the 2-sided 95% CI >=0.8 indicates Symbicort 'as needed' is non-inferior to Pulmicort bid. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|