Patients' Compliance to Home Nebulizer Therapy for Children's Asthma in China (CARE)

Patients' Compliance to Home Nebulizer Therapy for Children's Asthma in China An Observational Study to Investigate the Compliance of Home Nebulizer Therapy Among Children Aged 0-14 Years Old Clinically Diagnosed With Asthma

An observational study to investigate the compliance of home nebulizer therapy among children aged 0-14 years old clinically diagnosed with asthma

Study Overview

• Status: Completed
• Conditions: Paediatric Asthma

Detailed Description

Asthma is the most common chronic disease of childhood and the leading causes of childhood morbidity from chronic disease (GINA 2016). It is clear that inhaled corticosteroid (ICS) is foundation of asthma treatment and recommended both in Global Initiative for Asthma (GINA) and Chinese paediatric asthma diagnosis and treatment guideline. But the well-controlled rate of asthma was not ideal. National Parents of Asthmatic Children KAP Project Team (China) showed that 66.0% asthmatic children had asthma attacks in the past 12 months, 26.8% asthmatic children had visited the emergency department and 16.2% asthmatic children had been hospitalized. (Asthmatic Children KAP project team, 2013) .A few studies showed an increased risk of uncontrolled asthma or an asthma exacerbation in children with lower compliance (Jentzsch NS, 2012; Milgrom H, 1996). Poor compliance to inhaled corticosteroids may also contribute to poor asthma control level and asthma mortality (GINA 2016). Home nebulizer therapy has been recommended in GINA and Chinese Paediatric asthma diagnosis and treatment guideline. Compare to other inhalers, delivering ICS through nebulizer therapy need minimal patient's cooperation and normal breathing pattern (Deborah Elliott, 2011), but there are no studies to show the compliance of home nebulizer therapy in Chinese clinical practice. So we aim to investigate the compliance to home nebulizer therapy, and try to explore the related risk factor with poor compliance in this study.

• Study Type: Observational
• Enrollment (Actual): 512

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • Facility
    • Hefei, Anhui, China
      • Facility
  • Gansu
    • Lanzhou, Gansu, China
      • Facility
  • Guangdong
    • Guangzhou, Guangdong, China
      • Facility
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Children's Hospital
    • Nanjing, Jiangsu, China
      • Facility
    • Wuxi, Jiangsu, China
      • Facility
    • Xuzhou, Jiangsu, China
      • Facility
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Facility
  • Liaoning
    • Shenyang, Liaoning, China
      • Facility
  • Sichuan
    • Chengdu, Sichuan, China
      • Facility
  • Tianjin
    • Tianjin, Tianjin, China
      • Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

500 children aged 0-14 years old who are diagnosed with asthma and prescribed home nebulizer therapy treatment at tier-3 hospitals by investigators according to Chinese paediatric asthma diagnosis and treatment guideline

Description

Inclusion Criteria:

1. Aged 0-14 years old, clinical diagnosed as asthma according to Chinese paediatric asthma diagnosis and treatment guideline
2. Prescribed home nebulizer therapy for at least 3 month
3. The guardians must sign the Informed Consent Form; Subjects who can make decision by him/herself must also sign the Informed Consent Form

Diagnosis of paediatric asthma:

The patient who fulfil criteria 1 to 4 or criteria 4 plus any item of criteria 5 could be diagnosed as paediatric asthma.

1. Recurrent respiratory symptoms (wheeze, cough, dyspnoea, chest tightness), typically worse at night/early morning, exacerbated by exercise, viral infection, smoke, dust, pets, mold, dampness, weather changes, laughing, crying, allergens.
2. A musical, high-pitched whistling sound could be detected in both sides of the lung by auscultation of the chest. The wheezing is usually during exhalation.
3. Symptoms/signs above could be relieved automatically or by anti-asthmatic treatment.
4. Exclusion of the other diseases, which also could cause wheeze, cough, dyspnoea, chest tightness.
5. Atypical symptoms/signs without any wheeze or whistling sound (at least fulfil one of the following criteria):

1) The results of bronchial provocation test is positive. 2) Demonstrating reversible airflow limitation: i. The result of bronchial dilation test is positive. ii. Anti-asthmatic treatment is effective for lung function improvement. 3) The ratio of daily variation of PEF (consecutively more than two weeks) is more than 13%.

Exclusion Criteria:

1. Allergy to any inhaler cortical steroid
2. Presenting with differential diagnosis of asthma such as congenital heart disease, gastro-oesophageal reflux, bronchopulmonary dysplasis, bronchiolitis obliterans, etc
3. Parents/Guardian have problem in expression, understanding, writing and reading in Chinese judged by the investigator
4. Subjects are participating other on-going clinical studies
5. Subjects with other diseases that may interfere the study results judged by the investigators

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Median treatment compliance (%) derived using actual treatment frequency (monitored by electronic chips) divided by prescribed frequency	From 3 June 2017 to 3 March 2018, an expected average of 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients in different treatment compliance levels (<50%, 50 %≤-< 80%, 80%≤-≤120%, >120%) monitored by electric chips	From 3 June 2017 to 3 March 2018, an expected average of 3 months
Median treatment compliance (%) reported by caregivers derived using actual doses divided by prescribed doses	From 3 June 2017 to 3 March 2018, an expected average of 3 months
Proportion of patients in difference compliance levels reported by caregivers	From 3 June 2017 to 3 March 2018, an expected average of 3 months
Proportion of patients by severity	From 3 June 2017 to 3 March 2018, an expected average of 3 months
Factors associated with treatment compliance	From 3 June 2017 to 3 March 2018, an expected average of 3 months
The proportion of asthma control status (controlled, partly controlled and uncontrolled asthma) according to GINA 2016 definition at visit 2 to 4 overall and by compliance level.	From 3 June 2017 to 3 March 2018, an expected average of 3 months
The proportion of asthma control status according to TRACK for subjects under 5 years old	From 3 June 2017 to 3 March 2018, an expected average of 3 months
Factors associated with control levels (controlled, partly controlled and uncontrolled asthma)	From 3 June 2017 to 3 March 2018, an expected average of 3 months

Other Outcome Measures

Outcome Measure	Time Frame
Direct health expenditure of asthma treatment and management	From 3 June 2017 to 3 March 2018, an expected average of 3 months
caregiver's loss of working days	From 3 June 2017 to 3 March 2018, an expected average of 3 months
children's loss of kindergarten/school days	From 3 June 2017 to 3 March 2018, an expected average of 3 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Deyu Zhao, Nanjing Children's Hospital

Publications and helpful links

General Publications

• Zhao D, Chen D, Li L, Zou Y, Shang Y, Zhang C, Zhang L, Pan J, Chen Q, Ai T, Ni Q. CARE: an observational study of adherence to home nebulizer therapy among children with asthma. Ther Adv Respir Dis. 2021 Jan-Dec;15:1753466620986391. doi: 10.1177/1753466620986391.

Helpful Links

• CSR synopsis

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2017
• Primary Completion (Actual): May 9, 2018
• Study Completion (Actual): May 9, 2018

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 28, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Compliance; CARE; Paediatric asthma; Home nebulizer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: D5252R00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No