Asthma Control Test Guided Treatment in Chinese Subjects
Condition: Asthma
MeSH terms: Asthma
Intervention: ACT guided Routine Treatment; Routine Treatment
Intervention description: 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.; 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 530.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Cluster Randomization; Peak Expiratory Flow; Forced Expiratory Volume; Standardized Asthma Quality of Life Questionnaire; Asthma Control Test

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