Asthma Control Test Guided Treatment in Chinese Subjects

Study Overview
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Brief Summary
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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).

Official Title
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The Effectiveness of Asthma Control Test Guided Treatment Compared With Usual Care in China Adult Asthma Patients

Conditions
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Asthma

Intervention / Treatment
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* Drug: ACT guided Routine Treatment
* Drug: Routine Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria for study centre (clusters): General practice Located in Shanghai Providing asthma care Inclusion Criteria for subject at Visit 0 Age: 18 to 70 inclusive Gender: Male or Female Documented clinical history of asthma for at least 6 months prior to Visit 0 At Visit 0, a demonstrable reversible increase in FEV1 of at least 12 percent (%) (and >=200 milliliter [mL]), 15 minutes after inhaling a short-acting bronchodilator or; at any time in the last 2 years documentary evidence of a reversible increase in FEV1 of at least 12% (and >=200 mL) 15 minutes after inhaling a short-acting bronchodilator; or demonstrable reversible increase in morning PEF of at least 15% (and >=200 mL) either spontaneously or after inhalation of a short-acting bronchodilator History of using inhaled corticosteroids alone or combined with an inhaled long-acting beta two agonist (LABA) treatment within 1 year prior to Visit 0 Subjects must have an ACT score <20 at Visit 0 Subject must have been able to read, comprehend, and record information in Chinese A signed and dated written informed consent must be obtained from the subject prior to study participation Exclusion Criteria: History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 6 months before Visit 0 Subjects having severe and unstable asthma, with ACT score <12 at Visit 0, history of repeated severe exacerbations (3 per year) and/or a severe exacerbation in the previous 6 weeks before Visit 0. A current evidence of clinically significant uncontrolled medical condition or disease (e.g., psychological disorders, mental deficiency, severe hepatic and renal dysfunction, malignancy) Current smoker or ex-smoker with a more than 10 pack-year history of smoking Current clinically significant respiratory diseases other than asthma, (e.g., lung cancer, lung fibrosis, sarcoidosis, tuberculosis, chronic obstructive pulmonary disease) History of alcohol or medication abuse History of upper or lower respiratory tract infection within 4 weeks prior to Visit 0 Enrolled in an asthma clinic or outpatient service in the past 12 months that provides comprehensive asthma management Subjects with a history of adverse reaction including immediate or delayed hypersensitivity to any intranasal, inhaled, or systemic corticosteroid and LABA therapy and to components of the inhalation powder (e.g., lactose) at Visit 0. In addition, subjects with a history of severe milk protein allergy that, in the opinion of the Investigator, contraindicates the subject's participation will also be excluded Females who are currently pregnant and lactating Subjects who have received any of the following medications in the 6 weeks preceding visit 0: oral/parenteral corticosteroids, oral beta two-agonists or slow-release bronchodilators, sodium cromoglycate or nedocromil sodium, ketotifen, anticholinergics, and anti-Immunoglobulin-E treatment Subjects who comply poorly with asthma treatment in the opinion of the investigator/inability or unwillingness to take asthma medication (non-compliance), follow directions or unable to complete a written paper daily record card and self-rating questionnaires Concurrently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational medication or device, or has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) Subjects with contraindications to any asthma medications they will be taking during the study period, or whom should be excluded on account of the special warnings and precautions within the label of the asthma medication they are to be treated with during the study period Affiliation with Investigator Site: Is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the afore mentioned that is involved in this study Subjects who plan to move away from the geographical area where the study is being conducted during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects recruited at ACT centers<br>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. | Drug: ACT guided Routine Treatment<br>* 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.<br>|
| Active Comparator: Subjects recruited in the control centers<br>For subjects who will be recruited in the control centers, they will be treated based on doctor's subjective judgment. | Drug: Routine Treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cluster Randomization, Peak Expiratory Flow, Forced Expiratory Volume, Standardized Asthma Quality of Life Questionnaire, Asthma Control Test