Clinical trial NCT02868281: Asthma Control Test Guided Treatment in Chinese Subjects
Official title: The Effectiveness of Asthma Control Test Guided Treatment Compared With Usual Care in China Adult Asthma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Cluster Randomization
Peak Expiratory Flow
Forced Expiratory Volume
Standardized Asthma Quality of Life Questionnaire
Asthma Control Test
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: MacroStat
First posted: 2016-08-16
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Up to Week 24
Secondary outcomes:
measure: Mean Daytime Symptom Score Over the 24-week Treatment Period
timeFrame: Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24
measure: Mean Night-time Symptom Score Over the 24-week Treatment Period
timeFrame: Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24
measure: Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 24
timeFrame: Baseline (Day 1) and at Week 24
measure: Mean Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF) Over the 24-week Treatment Period
timeFrame: Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24
measure: Mean Evening (Post Meridiem [PM]) PEF Over the 24-week Treatment Period
timeFrame: Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24
measure: Mean Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) Total Score at Week 24
timeFrame: Baseline (Day 1) and at Week 24
measure: Time to First ACT Score >=20 or Improvement of More Than 3 Points in ACT Over the 24-week Treatment Period
timeFrame: Up to Week 24
Other outcomes:
measure: Annualized Rate of Moderate to Severe Asthma Exacerbation During 24-week Treatment Period
timeFrame: Up to Week 24
Locations:
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.