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| Name | Class |
|---|---|
| MacroStat | OTHER |
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This study is aimed to evaluate the effectiveness of Asthma Control Test (ACT) guided treatment compared with usual care in asthma subjects in China. It is designed to assist Chinese subjects and physicians improving adherence to the guidelines through the inclusion of the ACT in the patient's asthma management plan. This is a prospective, multicentre, cluster-randomized, open-label 24-week study. In this cluster-randomization design, each study center, considered as a cluster, will be randomized to either ACT guided treatment group or control group (usual care group). For the subjects who are recruited in the ACT centers, they will be treated based on the ACT score. If ACT score are equal to (=) 25 for more than equal to (>=) 3 months then the treatment will stepped-down; if ACT score >=20, less than (<) 25 or ACT=25 for <3 months then there will be no change and if ACT score less than (<=) 19 then the treatment will stepped-up. For subjects who are recruited in the control centers, they will be treated based on doctor's subjective judgment. Assignment to a treatment will not occur, as no treatment intervention is provided for this study. A total of 528 asthma subjects are planned in the study. The randomization will be stratified according to the Tier of the hospitals (Tier 3 verses Tier 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects recruited at ACT centers | Experimental | For the subjects who will be recruited in the ACT centers, they will be treated based on the ACT score. If ACT score are = 25 for >=3 months then step-down the treatment; if ACT score >=20, <25 or ACT=25 for <3 months then there will be no change and if ACT score less than (<=) 19 then step-up the treatment. |
|
| Subjects recruited in the control centers | Active Comparator | For subjects who will be recruited in the control centers, they will be treated based on doctor's subjective judgment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT guided Routine Treatment | Drug | The ACT is a validated, short, easy to use, and self-administered instrument used to assess asthma control. Subjects in this group received routine treatment as per ACT score. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had an ACT Total Score >=20 or an Improvement of More Than 3 Points in ACT During the 24-week Treatment Period | ACT is a self-administered questionnaire comprising five items that were assessed on a five point categorical scale (1 to 5) and the scores are summed to give a total score ranging from 5 to 25, with a score of >=20 denoting 'well-controlled asthma', a score of 16-19 denoting 'not well-controlled asthma', and a score of <=15 denoting 'very poorly controlled asthma'. The total score was calculated as the sum of the scores from all 5 questions. Higher scores indicates improved asthma control. The recall period of the questionnaire was four weeks. | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daytime Symptom Score Over the 24-week Treatment Period | Participants recorded daytime asthma symptom scores in the daily record card (DRC). Any asthma-related symptoms, such as wheeze, shortness of breath, cough or chest tightness experienced during the previous 12 hours were rated as: 0= no symptoms during the day, 1= symptoms for one short period during the day, 2= symptoms for two or more short periods during the day, 3= symptoms for most of the day which did not affect daily activities, 4= symptoms for most of the day which did affect normal daily activities, 5= symptoms so severe that participant could not go to work or perform normal daily activities. Daytime symptom score was calculated by taking average of scores for all questions. The mean daytime asthma symptom score was calculated for each participant during the 4-weekly interval (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks. Score ranged from 0-5, higher scores indicates severe symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Rate of Moderate to Severe Asthma Exacerbation During 24-week Treatment Period | Exacerbations were assessed by the physician at each scheduled visit by reviewing the DRC, as well as specific questioning on adverse events. A moderate asthma exacerbation was defined as a deterioration in asthma requiring treatment with an oral corticosteroid. Individual courses of oral corticosteroids were classified as separate exacerbations only if they were administered more than 1 week apart. Any course started within one week of finishing the previous course was considered part of the previous exacerbation. A severe asthma exacerbation was defined as a deterioration in asthma which requires hospital admission. Annualized Rate of moderate to severe asthma exacerbation during 24-week treatment period is presented. |
Inclusion Criteria:
Inclusion criteria for study centre (clusters):
Inclusion Criteria for subject at Visit 0
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Shanghai | 200032 | China | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33892217 | Background | Ye L, Gao X, Tu C, Du C, Gu W, Hang J, Zhao L, Jie Z, Li H, Lu Y, Wang J, Jin X, Hu X, Wu S, Jin M. Comparative analysis of effectiveness of asthma control test-guided treatment versus usual care in patients with asthma from China. Respir Med. 2021 Jun;182:106382. doi: 10.1016/j.rmed.2021.106382. Epub 2021 Mar 30. |
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IPD for this study is available via the Clinical Study Data Request site
IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Total 583 participants were screened and 530 participants were enrolled into the study (53 participants were screen failures).
Participants were enrolled from 12 centers in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | ACT Guided Treatment Group | Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted. |
| FG001 | Usual Care Group | Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ACT Guided Treatment Group | Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants Who Had an ACT Total Score >=20 or an Improvement of More Than 3 Points in ACT During the 24-week Treatment Period | ACT is a self-administered questionnaire comprising five items that were assessed on a five point categorical scale (1 to 5) and the scores are summed to give a total score ranging from 5 to 25, with a score of >=20 denoting 'well-controlled asthma', a score of 16-19 denoting 'not well-controlled asthma', and a score of <=15 denoting 'very poorly controlled asthma'. The total score was calculated as the sum of the scores from all 5 questions. Higher scores indicates improved asthma control. The recall period of the questionnaire was four weeks. | Intent-To-Treat (ITT) Population consisted of all participants who signed informed consent form, were randomized and who had at least one post-Baseline assessment. Only those participants with data available at the specified data point were analyzed. | Posted | Number | Percentage of participants | Up to Week 24 |
|
Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACT Guided Treatment Group | Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 27, 2016 | Jul 2, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 11, 2019 | Jul 2, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Routine Treatment | Drug | Subjects in the controlled treatment group will receive usual care of asthma. This treatment was monitored and adjusted as usual by the patient's general practitioner. |
|
| Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24 |
| Mean Night-time Symptom Score Over the 24-week Treatment Period | Participants recorded night-time asthma symptom scores in the DRC. Any asthma-related symptoms, such as wheeze, shortness of breath, cough or chest tightness experienced during the previous 12 hours were rated as: 0= no symptoms during the night, 1= symptoms causing to wake once or wake early, 2= symptoms causing to wake twice or more (including waking early), 3= symptoms causing to be awake for most of the night, 4= symptoms so severe that participant did not sleep at all. Night-time symptom score was calculated by taking average of scores for all questions. The mean nighttime asthma symptom score was calculated for each participant during the 4 weekly interval (Weeks 1-4; Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks. Score ranged from 0-5, higher scores indicates severe symptoms. | Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24 |
| Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 24 | FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured by spirometry. Baseline was defined as value at Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Baseline (Day 1) and at Week 24 |
| Mean Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF) Over the 24-week Treatment Period | PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Participants were provided with a Mini-Wright Peak Flow Meter and were taught how to measure and record their PEF. Participants recorded on DRC the best of three PEF measurements, using a Mini-Wright peak flow meter in the morning (7:00 to 10:00 AM) before taking any asthma drug. Mean AM PEF was calculated for each participant during the 4-weekly interval (Weeks 1-4; Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks. | Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24 |
| Mean Evening (Post Meridiem [PM]) PEF Over the 24-week Treatment Period | PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Participants were provided with a Mini-Wright Peak Flow Meter and were taught how to measure and record their PEF. Participants recorded on DRC the best of three PEF measurements, using a Mini-Wright peak flow meter in the evening (6:00 to 9:00 PM) before taking any asthma drug. Mean PM PEF was calculated for each participant during the 4-weekly interval (Weeks 1-4; Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks. | Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24 |
| Mean Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) Total Score at Week 24 | The AQLQ(S) contains 32 items in four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). Participant's response to each question was rated on a seven-point scale (1 to 7) where a value of 1 indicates "total impairment" and a value of 7 indicates "no impairment". The total AQLQ(S) score is calculated as the mean of all 32 items in the questionnaire. Hence, the total AQLQ(S) score ranged from 1 to 7 with higher scores indicating a higher quality of life. A change in score of greater than 0.5 can be considered clinically important. Baseline was defined as value at Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Baseline (Day 1) and at Week 24 |
| Time to First ACT Score >=20 or Improvement of More Than 3 Points in ACT Over the 24-week Treatment Period | ACT is a self-administered questionnaire comprising five items that were assessed on a five point categorical scale (1 to 5) and the scores are summed to give a total score ranging from 5 to 25, with a score of >=20 denoting 'well-controlled asthma', a score of 16-19 denoting 'not well-controlled asthma', and a score of <=15 denoting 'very poorly controlled asthma'. Higher scores indicates improved asthma control. The recall period of the questionnaire was four weeks. Median and inter-quartile range (first and third quartiles) are presented for time to first ACT score >=20 or improvement of more than 3 points in ACT over the 24-week treatment period. | Up to Week 24 |
| Up to Week 24 |
| Shanghai |
| 200052 |
| China |
| GSK Investigational Site | Shanghai | 200135 | China |
| GSK Investigational Site | Shanghai | 201299 | China |
| GSK Investigational Site | Shanghai | 201700 | China |
| GSK Investigational Site | Shanghai | China |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| Had protocol-defined asthma exacerbation |
|
| Inclusion/exclusion criteria violation |
|
| Long journey/moving away |
|
| BG001 | Usual Care Group | Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ACT Guided Treatment Group |
Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted. |
| OG001 | Usual Care Group | Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score. |
|
|
|
| Secondary | Mean Daytime Symptom Score Over the 24-week Treatment Period | Participants recorded daytime asthma symptom scores in the daily record card (DRC). Any asthma-related symptoms, such as wheeze, shortness of breath, cough or chest tightness experienced during the previous 12 hours were rated as: 0= no symptoms during the day, 1= symptoms for one short period during the day, 2= symptoms for two or more short periods during the day, 3= symptoms for most of the day which did not affect daily activities, 4= symptoms for most of the day which did affect normal daily activities, 5= symptoms so severe that participant could not go to work or perform normal daily activities. Daytime symptom score was calculated by taking average of scores for all questions. The mean daytime asthma symptom score was calculated for each participant during the 4-weekly interval (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks. Score ranged from 0-5, higher scores indicates severe symptoms. | ITT Population. Only those participants with data available at the specified data point were analyzed (represented by n=x in the category titles). | Posted | Least Squares Mean | Standard Error | Scores on a scale | Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24 |
|
|
|
|
| Secondary | Mean Night-time Symptom Score Over the 24-week Treatment Period | Participants recorded night-time asthma symptom scores in the DRC. Any asthma-related symptoms, such as wheeze, shortness of breath, cough or chest tightness experienced during the previous 12 hours were rated as: 0= no symptoms during the night, 1= symptoms causing to wake once or wake early, 2= symptoms causing to wake twice or more (including waking early), 3= symptoms causing to be awake for most of the night, 4= symptoms so severe that participant did not sleep at all. Night-time symptom score was calculated by taking average of scores for all questions. The mean nighttime asthma symptom score was calculated for each participant during the 4 weekly interval (Weeks 1-4; Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks. Score ranged from 0-5, higher scores indicates severe symptoms. | ITT Population. Only those participants with data available at the specified data point were analyzed (represented by n=x in the category titles). | Posted | Least Squares Mean | Standard Error | Scores on a scale | Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24 |
|
|
|
|
| Secondary | Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 24 | FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured by spirometry. Baseline was defined as value at Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | ITT Population. Only those participants with data available at the specified data point were analyzed. | Posted | Least Squares Mean | Standard Error | Liters | Baseline (Day 1) and at Week 24 |
|
|
|
|
| Secondary | Mean Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF) Over the 24-week Treatment Period | PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Participants were provided with a Mini-Wright Peak Flow Meter and were taught how to measure and record their PEF. Participants recorded on DRC the best of three PEF measurements, using a Mini-Wright peak flow meter in the morning (7:00 to 10:00 AM) before taking any asthma drug. Mean AM PEF was calculated for each participant during the 4-weekly interval (Weeks 1-4; Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks. | ITT Population. Only those participants with data available at the specified data point were analyzed (represented by n=x in the category titles). | Posted | Least Squares Mean | Standard Error | Liters per minute | Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24 |
|
|
|
|
| Secondary | Mean Evening (Post Meridiem [PM]) PEF Over the 24-week Treatment Period | PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Participants were provided with a Mini-Wright Peak Flow Meter and were taught how to measure and record their PEF. Participants recorded on DRC the best of three PEF measurements, using a Mini-Wright peak flow meter in the evening (6:00 to 9:00 PM) before taking any asthma drug. Mean PM PEF was calculated for each participant during the 4-weekly interval (Weeks 1-4; Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks. | ITT Population. Only those participants with data available at the specified data point were analyzed (represented by n=x in the category titles). | Posted | Least Squares Mean | Standard Error | Liters per minute | Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24 |
|
|
|
|
| Secondary | Mean Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) Total Score at Week 24 | The AQLQ(S) contains 32 items in four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). Participant's response to each question was rated on a seven-point scale (1 to 7) where a value of 1 indicates "total impairment" and a value of 7 indicates "no impairment". The total AQLQ(S) score is calculated as the mean of all 32 items in the questionnaire. Hence, the total AQLQ(S) score ranged from 1 to 7 with higher scores indicating a higher quality of life. A change in score of greater than 0.5 can be considered clinically important. Baseline was defined as value at Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | ITT Population. Only those participants with data available at the specified data point were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and at Week 24 |
|
|
|
|
| Secondary | Time to First ACT Score >=20 or Improvement of More Than 3 Points in ACT Over the 24-week Treatment Period | ACT is a self-administered questionnaire comprising five items that were assessed on a five point categorical scale (1 to 5) and the scores are summed to give a total score ranging from 5 to 25, with a score of >=20 denoting 'well-controlled asthma', a score of 16-19 denoting 'not well-controlled asthma', and a score of <=15 denoting 'very poorly controlled asthma'. Higher scores indicates improved asthma control. The recall period of the questionnaire was four weeks. Median and inter-quartile range (first and third quartiles) are presented for time to first ACT score >=20 or improvement of more than 3 points in ACT over the 24-week treatment period. | ITT Population. Only those participants with data available at the specified data point were analyzed. | Posted | Median | Inter-Quartile Range | Days | Up to Week 24 |
|
|
|
|
| Other Pre-specified | Annualized Rate of Moderate to Severe Asthma Exacerbation During 24-week Treatment Period | Exacerbations were assessed by the physician at each scheduled visit by reviewing the DRC, as well as specific questioning on adverse events. A moderate asthma exacerbation was defined as a deterioration in asthma requiring treatment with an oral corticosteroid. Individual courses of oral corticosteroids were classified as separate exacerbations only if they were administered more than 1 week apart. Any course started within one week of finishing the previous course was considered part of the previous exacerbation. A severe asthma exacerbation was defined as a deterioration in asthma which requires hospital admission. Annualized Rate of moderate to severe asthma exacerbation during 24-week treatment period is presented. | ITT Population. Only those participants with data available at the specified data point were analyzed. | Posted | Mean | 95% Confidence Interval | Exacerbations per year | Up to Week 24 |
|
|
|
|
| 1 |
| 252 |
| 9 |
| 252 |
| 82 |
| 252 |
| EG001 | Usual Care Group | Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score. | 0 | 278 | 14 | 278 | 123 | 278 |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Otitis media chronic | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Salpingitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Pelvic adhesions | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Uterine polyp | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypertrophic anal papilla | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Subclavian artery occlusion | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Branchial cleft sinus | Congenital, familial and genetic disorders | MedDRA 21.0 | Systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pelvic inflammatory disease | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pulpitis dental | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Tinea cruris | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Conjunctivitis viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Urethritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Laryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dysbacteriosis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gastrointestinal hypomotility | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gingival swelling | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Breath odour | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tooth impacted | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Muscle injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Tooth injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Balanoposthitis | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Endometrial thickening | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Menstrual disorder | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pelvic fluid collection | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Breast hyperplasia | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Adrenal mass | Endocrine disorders | MedDRA 21.0 | Systematic Assessment |
|
| Thyroid mass | Endocrine disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Scleritis | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vitreous opacities | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Myofascitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Soft tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cerebral arteriosclerosis | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Poor quality sleep | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vascular headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Urate nephropathy | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Glomerulonephritis chronic | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vitamin B1 deficiency | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 21.0 | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Weeks 5-8, n=227, 249 |
|
|
| Weeks 9-12, n=217, 240 |
|
|
| Weeks 13-16, n=210, 238 |
|
|
| Weeks 17-20, n=207, 233 |
|
|
| Weeks 21-24, n=205, 227 |
|
|
| Mixed Model Repeat Measures |
| 0.156 |
| Difference in Least Squares Mean |
| -0.1 |
| 2-Sided |
| 95 |
| -0.2 |
| 0.0 |
Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. |
| Other |
| Mixed Model Repeat Measures | 0.245 | Difference in Least Squares Mean | -0.1 | 2-Sided | 95 | -0.2 | 0.0 | Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. | Other |
| Mixed Model Repeat Measures | 0.057 | Difference in Least Squares Mean | -0.1 | 2-Sided | 95 | -0.2 | 0.0 | Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. | Other |
| Mixed Model Repeat Measures | 0.151 | Difference in Least Squares Mean | -0.1 | 2-Sided | 95 | -0.2 | 0.0 | Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. | Other |
| Mixed Model Repeat Measures | 0.114 | Difference in Least Squares Mean | -0.1 | 2-Sided | 95 | -0.2 | 0.0 | Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. | Other |
| Weeks 5-8, n=226, 249 |
|
|
| Weeks 9-12, n=217, 240 |
|
|
| Weeks 13-16, n=209, 238 |
|
|
| Weeks 17-20, n=207, 233 |
|
|
| Weeks 21-24, n=205, 227 |
|
|
| Mixed Model Repeat Measures |
| 0.546 |
| Difference in Least Squares Mean |
| -0.04 |
| 2-Sided |
| 95 |
| -0.16 |
| 0.09 |
Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. |
| Other |
| Mixed Model Repeat Measures | 0.314 | Difference in Least Squares Mean | -0.06 | 2-Sided | 95 | -0.17 | 0.06 | Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. | Other |
| Mixed Model Repeat Measures | 0.197 | Difference in Least Squares Mean | -0.07 | 2-Sided | 95 | -0.19 | 0.04 | Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. | Other |
| Mixed Model Repeat Measures | 0.282 | Difference in Least Squares Mean | -0.06 | 2-Sided | 95 | -0.17 | 0.06 | Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. | Other |
| Mixed Model Repeat Measures | 0.543 | Difference in Least Squares Mean | -0.03 | 2-Sided | 95 | -0.15 | 0.08 | Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. | Other |
| Weeks 5-8, n=228, 251 |
|
|
| Weeks 9-12, n=220, 241 |
|
|
| Weeks 13-16, n=211, 239 |
|
|
| Weeks 17-20, n=207, 235 |
|
|
| Weeks 21-24, n=206, 229 |
|
|
| Mixed Model Repeat Measures |
| 0.587 |
| Difference in Least Squares Mean |
| -7.2 |
| 2-Sided |
| 95 |
| -35.5 |
| 21.2 |
Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. |
| Other |
| Mixed Model Repeat Measures | 0.721 | Difference in Least Squares Mean | -4.7 | 2-Sided | 95 | -33.1 | 23.7 | Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. | Other |
| Mixed Model Repeat Measures | 0.801 | Difference in Least Squares Mean | -3.3 | 2-Sided | 95 | -31.7 | 25.1 | Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. | Other |
| Mixed Model Repeat Measures | 0.704 | Difference in Least Squares Mean | -5.0 | 2-Sided | 95 | -33.3 | 23.4 | Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. | Other |
| Mixed Model Repeat Measures | 0.762 | Difference in Least Squares Mean | -4.0 | 2-Sided | 95 | -32.4 | 24.5 | Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. | Other |
| Weeks 5-8, n=228, 251 |
|
|
| Weeks 9-12, n=220, 241 |
|
|
| Weeks 13-16, n=211, 239 |
|
|
| Weeks 17-20, n=207, 235 |
|
|
| Weeks 21-24, n=206, 229 |
|
|
| Mixed Model Repeat Measures |
| 0.538 |
| Difference in Least Squares Mean |
| -8.4 |
| 2-Sided |
| 95 |
| -37.8 |
| 21.0 |
Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. |
| Other |
| Mixed Model Repeat Measures | 0.716 | Difference in Least Squares Mean | -5.0 | 2-Sided | 95 | -34.4 | 24.5 | Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. | Other |
| Mixed Model Repeat Measures | 0.822 | Difference in Least Squares Mean | -3.1 | 2-Sided | 95 | -32.5 | 26.3 | Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. | Other |
| Mixed Model Repeat Measures | 0.767 | Difference in Least Squares Mean | -4.0 | 2-Sided | 95 | -33.4 | 25.4 | Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. | Other |
| Mixed Model Repeat Measures | 0.779 | Difference in Least Squares Mean | -3.8 | 2-Sided | 95 | -33.4 | 25.7 | Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor. | Other |