Status:
COMPLETED
Post-marketing Safety Monitoring Program of Fluticasone Propionate (FP) in Chinese Subjects With Asthma Aged 1 to <4 Years
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
1-4 years
Brief Summary
For the prophylactic treatment of asthma, FP inhaled aerosol (Flixotide ®) administered via a pressurized metered-dose inhaler (pMDI) was approved in China in adults, adolescents older than 16 years o...
Eligibility Criteria
Inclusion
- An appropriately signed and dated assent must be obtained from the parent/guardian of the subject.
- Subjects with 1 to \<4 years of age at Visit 1.
- Subjects who have been prescribed Flixotide 50 µg for a medically appropriate use for the first time will be included in this observational program; Flixotide 50 µg therapy should be in line with the approved dosing: 50 to100 µg twice daily; subjects should have the ability to inhale the doses via a pediatric spacer with a face mask appropriately; subjects who have been exposed to Flixotide 50 µg, 125 µg and 250 µg treatment previously will not be included.
- The parent/guardian of the subject must provide reliable contact information which includes home phone or cell phone for the follow up visits.
- The parent/guardian of the subject must have the ability to comply study procedures.
- Specific information regarding warnings, precautions, contraindications, AEs, and other pertinent information on Flixotide 50 μg that may impact subject eligibility is provided in the approved product label.
Exclusion
- \-
Key Trial Info
Start Date :
January 9 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 27 2018
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT03273946
Start Date
January 9 2018
End Date
September 27 2018
Last Update
October 2 2019
Active Locations (4)
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1
GSK Investigational Site
Shenzhen, Guangdong, China, 518038
2
GSK Investigational Site
Shanghai, China, 200040
3
GSK Investigational Site
Shanghai, China, 200092
4
GSK Investigational Site
Shanghai, China, 200127