Last updated: 07/08/2021 10:50:06
Asthma Control Test guided treatment in Chinese subjects
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: The effectiveness of Asthma Control Test guided treatment compared with usual care in China adult asthma patients
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Percentage of subjects who have an ACT score >=20 or an improvement of more than 3 points in ACT during the 24-week treatment period
Timeframe: 24 weeks
Secondary outcomes:
Mean daytime symptom score over the 24-week treatment period
Timeframe: 24 weeks
Mean night-time symptom score over the 24-week treatment period
Timeframe: 24 weeks
Mean change from Baseline to the end of study in Forced Expiratory Volume in one second (FEV1)
Timeframe: Baseline and 24 weeks
Mean morning (ante meridiem [AM]) Peak Expiratory Flow (PEF) over the 24-week treatment period
Timeframe: 24 weeks
Mean evening (post meridiem [PM]) PEF over the 24-week treatment period
Timeframe: 24 weeks
Mean change from Baseline to the end of study in Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) score
Timeframe: Baseline and 24 weeks
Time to first ACT score >=20 or improvement of more than 3 points in ACT over the 24-week treatment period
Timeframe: 24 weeks
Interventions:
Drug: ACT guided Routine Treatment
Drug: Routine Treatment
Enrollment:
530
Observational study model:
Not applicable
Primary completion date:
2019-09-08
Time perspective:
Not applicable
Clinical publications:
Ling Ye, Xiwen Gao, Chunlin Tu, Chunling Du, Wenchao Gu, Jingqing Hang, Lei Zhao, Zhijun Jie, Hailing Li, Yueming Lu, Jin Wang, Xiaoyan Jin, Xiao Hu, Shunquan Wu, Meiling Jin. Comparative analysis of effectiveness of Asthma Control Test-guided treatment versus usual care in patients with asthma from China. Respir Med. 2021;182:106382
DOI: 10.1016/j.rmed.2021.106382
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Macrostat
Study date(s)
August 2016 to August 2019
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 70 years
Accepts healthy volunteers
No
- Inclusion criteria for study centre (clusters):
- General practice
- 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.
Inclusion and exclusion criteria
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
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2019-09-08
Actual study completion date
2019-09-08
Plain language summaries
Summary of results in plain language
Available language(s): English, Chinese (China)
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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