Asthma Control Test Guided Treatment in Chinese Subjects

NCT02868281 | Completed Phase 4 Results

• 1 other identifier: 201097
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 6

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).

Conditions

Asthma

Keywords

Cluster Randomization; Peak Expiratory Flow; Forced Expiratory Volume; Standardized Asthma Quality of Life Questionnaire; Asthma Control Test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Mean Daytime Symptom Score Over the 24-week Treatment Period

  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

  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

  Baseline (Day 1) and at Week 24

• Mean Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF) Over the 24-week Treatment Period

  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

  Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24

Other Outcomes (1)

• Annualized Rate of Moderate to Severe Asthma Exacerbation During 24-week Treatment Period

  Up to Week 24

Study Arms (2)

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.

Drug: ACT guided Routine 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.

Drug: Routine Treatment

Interventions

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.

Subjects recruited at ACT centers

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.

Subjects recruited in the control centers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General practice
• Located in Shanghai
• Providing asthma care
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead
• MacroStat: collaborator

Study Sites (6)

GSK Investigational Site

Shanghai, 200032, China

Location

GSK Investigational Site

Shanghai, 200052, China

Location

GSK Investigational Site

Shanghai, 200135, China

Location

GSK Investigational Site

Shanghai, 201299, China

Location

GSK Investigational Site

Shanghai, 201700, China

Location

GSK Investigational Site

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 33892217 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 16, 2016
• Study Start: August 26, 2016
• Primary Completion: August 9, 2019
• Study Completion: August 9, 2019
• Last Updated: July 8, 2021
• Results First Posted: August 3, 2020

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
• Access Criteria: 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.

Locations

CN (6)