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

April 28, 2019 updated by: AstraZeneca

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
512

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Median treatment compliance (%) derived using actual treatment frequency (monitored by electronic chips) divided by prescribed frequency
Time Frame: From 3 June 2017 to 3 March 2018, an expected average of 3 months
From 3 June 2017 to 3 March 2018, an expected average of 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of patients in different treatment compliance levels (<50%, 50 %≤-< 80%, 80%≤-≤120%, >120%) monitored by electric chips
Time Frame: From 3 June 2017 to 3 March 2018, an expected average of 3 months
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
Time Frame: From 3 June 2017 to 3 March 2018, an expected average of 3 months
From 3 June 2017 to 3 March 2018, an expected average of 3 months
Proportion of patients in difference compliance levels reported by caregivers
Time Frame: From 3 June 2017 to 3 March 2018, an expected average of 3 months
From 3 June 2017 to 3 March 2018, an expected average of 3 months
Proportion of patients by severity
Time Frame: From 3 June 2017 to 3 March 2018, an expected average of 3 months
From 3 June 2017 to 3 March 2018, an expected average of 3 months
Factors associated with treatment compliance
Time Frame: From 3 June 2017 to 3 March 2018, an expected average of 3 months
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.
Time Frame: From 3 June 2017 to 3 March 2018, an expected average of 3 months
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
Time Frame: From 3 June 2017 to 3 March 2018, an expected average of 3 months
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)
Time Frame: From 3 June 2017 to 3 March 2018, an expected average of 3 months
From 3 June 2017 to 3 March 2018, an expected average of 3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Direct health expenditure of asthma treatment and management
Time Frame: From 3 June 2017 to 3 March 2018, an expected average of 3 months
From 3 June 2017 to 3 March 2018, an expected average of 3 months
caregiver's loss of working days
Time Frame: From 3 June 2017 to 3 March 2018, an expected average of 3 months
From 3 June 2017 to 3 March 2018, an expected average of 3 months
children's loss of kindergarten/school days
Time Frame: From 3 June 2017 to 3 March 2018, an expected average of 3 months
From 3 June 2017 to 3 March 2018, an expected average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Deyu Zhao, Nanjing Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 9, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 9, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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