Paediatric Asthma Clinical Trial
— CAREOfficial 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
| NCT number | NCT03156998 |
| Other study ID # | D5252R00001 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 25, 2017 |
| Est. completion date | May 9, 2018 |
| Verified date | April 2019 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
An observational study to investigate the compliance of home nebulizer therapy among children aged 0-14 years old clinically diagnosed with asthma
| Status | Completed |
| Enrollment | 512 |
| Est. completion date | May 9, 2018 |
| Est. primary completion date | May 9, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 14 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Facility | Bengbu | Anhui |
| China | Facility | Chengdu | Sichuan |
| China | Facility | Guangzhou | Guangdong |
| China | Facility | Hefei | Anhui |
| China | Facility | Lanzhou | Gansu |
| China | Facility | Nanchang | Jiangxi |
| China | Facility | Nanjing | Jiangsu |
| China | Nanjing Children's Hospital | Nanjing | Jiangsu |
| China | Facility | Shenyang | Liaoning |
| China | Facility | Tianjin | Tianjin |
| China | Facility | Wuxi | Jiangsu |
| China | Facility | Xuzhou | Jiangsu |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Direct health expenditure of asthma treatment and management | From 3 June 2017 to 3 March 2018, an expected average of 3 months | ||
| Other | caregiver's loss of working days | From 3 June 2017 to 3 March 2018, an expected average of 3 months | ||
| Other | children's loss of kindergarten/school days | From 3 June 2017 to 3 March 2018, an expected average of 3 months | ||
| Primary | 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 | 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 | ||
| Secondary | 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 | ||
| Secondary | Proportion of patients in difference compliance levels reported by caregivers | From 3 June 2017 to 3 March 2018, an expected average of 3 months | ||
| Secondary | Proportion of patients by severity | From 3 June 2017 to 3 March 2018, an expected average of 3 months | ||
| Secondary | Factors associated with treatment compliance | From 3 June 2017 to 3 March 2018, an expected average of 3 months | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 |