Last updated: 09/10/2019 15:40:07
Post-marketing safety monitoring program of fluticasone propionate (FP) in Chinese subjects with asthma aged 1 to <4 years
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects with known adverse events (AEs) and serious AEs (SAEs)
Timeframe: Up to Week 12
Number of subjects with unexpected AEs and SAEs
Timeframe: Up to Week 12
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
158
Primary completion date:
2018-27-09
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
January 2018 to September 2018
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
1 - 4 years
Accepts healthy volunteers
No
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Protocol and statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
No study documents available
Recruitment status
Study complete
Actual primary completion date
2018-27-09
Actual study completion date
2018-27-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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