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Paediatric AsthmaCARENCT03156998

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

An observational study of Paediatric Asthma, run by AstraZeneca at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages Up to 14 years
Conditions the study is for
Paediatric Asthma
How many people
512 participants
Where
12 sitesChina
Study dates
25 Jul 2017to 9 May 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 14 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • Aged 0-14 years old, clinical diagnosed as asthma according to Chinese paediatric asthma diagnosis and treatment guideline
  • Prescribed home nebulizer therapy for at least 3 month
  • 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.
  • 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.
Show all 11Show fewer
  • 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.
  • Symptoms/signs above could be relieved automatically or by anti-asthmatic treatment.
  • Exclusion of the other diseases, which also could cause wheeze, cough, dyspnoea, chest tightness.
  • 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%.

Who cannot join

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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Facility

    Bengbu, Anhui

  • Facility

    Chengdu, Sichuan

  • Facility

    Guangzhou, Guangdong

  • Facility

    Hefei, Anhui

  • Facility

    Lanzhou, Gansu

  • Facility

    Nanchang, Jiangxi

  • Nanjing Children's Hospital

    Nanjing, Jiangsu, 210008

  • Facility

    Nanjing, Jiangsu

  • Facility

    Shenyang, Liaoning

  • Facility

    Tianjin, Tianjin Municipality

  • Facility

    Wuxi, Jiangsu

  • Facility

    Xuzhou, Jiangsu

Other trials in China

About this study

Official title: 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

Read the 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.

Keywords
CARE, Paediatric asthma, Compliance, Home nebulizer
Medical subject headings
Patient Compliance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median treatment compliance (%) derived using actual treatment frequency (monitored by electronic chips) divided by prescribed frequency

    Measured: From 3 June 2017 to 3 March 2018, an expected average of 3 months

Secondary outcomes (8)

  1. Proportion of patients in different treatment compliance levels (<50%, 50 %≤-< 80%, 80%≤-≤120%, >120%) monitored by electric chips

    Measured: From 3 June 2017 to 3 March 2018, an expected average of 3 months

  2. Median treatment compliance (%) reported by caregivers derived using actual doses divided by prescribed doses

    Measured: From 3 June 2017 to 3 March 2018, an expected average of 3 months

  3. Proportion of patients in difference compliance levels reported by caregivers

    Measured: From 3 June 2017 to 3 March 2018, an expected average of 3 months

  4. Proportion of patients by severity

    Measured: From 3 June 2017 to 3 March 2018, an expected average of 3 months

  5. Factors associated with treatment compliance

    Measured: From 3 June 2017 to 3 March 2018, an expected average of 3 months

  6. 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.

    Measured: From 3 June 2017 to 3 March 2018, an expected average of 3 months

  7. The proportion of asthma control status according to TRACK for subjects under 5 years old

    Measured: From 3 June 2017 to 3 March 2018, an expected average of 3 months

  8. Factors associated with control levels (controlled, partly controlled and uncontrolled asthma)

    Measured: From 3 June 2017 to 3 March 2018, an expected average of 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2017
  2. Study start25 Jul 2017
  3. Primary completion9 May 2018
  4. Study completion9 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
512 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03156998
Sponsor's protocol ID
D5252R00001
Acronym
CARE
Status last verified
Apr 2019
First submitted
16 May 2017
Last updated
30 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 33541235

Questions about this trial

What is this clinical trial studying?

An observational study of Paediatric Asthma, run by AstraZeneca at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03156998, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.

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