Post-marketing Safety Monitoring Program of Fluticasone Propionate (FP) in Chinese Subjects With Asthma Aged 1 to <4 Years

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03273946
• Other study ID #: 207734
• Status: Completed
• Start date: January 9, 2018
• Est. completion date: September 27, 2018

Study information

• Verified date: September 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: September 27, 2018
• Est. primary completion date: September 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 4 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fluticasone propionate
Fluticasone propionate is an inhaled corticosteroid to be used via a pediatric spacer device with a face mask for prophylactic treatment of asthma.

Locations

Country	Name	City	State
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Any Adverse Event (AE) or Adverse Drug Reaction (ADR)	An AE is defined as any untoward medical event which occurred in a participant or clinical study participant, which is temporally associated with the use of the medical product, whether or not considered related to the product. An ADR is defined as AE related to study drug and listed in the package insert. Number of participants who had at least one AE or ADR are presented.	Up to Week 12
Primary	Number of Participants With Any Serious Adverse Event (SAE) or Non-SAE	Any untoward medical occurrence resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, possible drug-induced liver injury or any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent serious outcomes were categorized as SAE. Number of participants who had at least one SAE or non-SAE are presented.	Up to Week 12
Primary	Number of Participants With Any New, Unexpected AE or Safety Signal	An unexpected AE is defined as any adverse reaction whose nature and intensity have not been previously observed and documented for the study product (e.g. in the investigator brochure, product information). A safety signal is information on a new or known AE that may be caused by a medicine and requires further investigation. Number of participants with any new unexpected AE or safety signal are presented.	Up to Week 12