Clinical trial NCT03273946: Post-marketing Safety Monitoring Program of Fluticasone Propionate (FP) in Chinese Subjects With Asthma Aged 1 to <4 Years
Official title: Post-Marketing Observational Study to Evaluate Safety Profile of Flixotide 50 μg pMDI Treatment in Chinese Subjects With Asthma Aged 1-<4 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: CCI18781
Observational
Post-marketing
Fluticasone propionate
Asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-09-06
Enrollment: 158
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects aged between 1 to \<4, diagnosed with asthma, who have been prescribed FP 50 µg for appropriate medical use for the first time in China will be included in this study.

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 of age and children aged 4 to 16 years. This post-marketing safety monitoring program will evaluate the safety profile of FP 50 micrograms (µg) inhaled via a pediatric spacer device with a face mask in Chinese subjects aged 1 to \<4 years. The adverse drug reactions (ADRs) and predictors of these adverse reactions among subjects will be reported. This single arm observational study will include subjects prescribed with FP 50 µg inhaled via a pediatric spacer device with a face mask. The maximum duration of the study will be 12 weeks with 3 visits. Visit 1 (Day 1) will be on-site visit and will also mark the start of the observational program. The follow-up visits will be scheduled at Visit 2 (Week 4), and Visit 3 (Week 12) conducted on site or by telephone. A total of 150 asthmatic subjects who have been prescribed FP 50 µg treatment for appropriate medical use for the first time in China will be enrolled in the study. Flixotide is a registered trademark of GlaxoSmithKline (GSK) group of companies.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

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Primary outcomes:
measure: Number of Participants With Any Adverse Event (AE) or Adverse Drug Reaction (ADR)
timeFrame: Up to Week 12
measure: Number of Participants With Any Serious Adverse Event (SAE) or Non-SAE
timeFrame: Up to Week 12
measure: Number of Participants With Any New, Unexpected AE or Safety Signal
timeFrame: Up to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: GSK Investigational Site
state: Guangdong
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: