Asthma
Conditions
Keywords
CCI18781, Observational, Post-marketing, Fluticasone propionate, Asthma
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.
Interventions
DRUGFluticasone propionate
Fluticasone propionate is an inhaled corticosteroid to be used via a pediatric spacer device with a face mask for prophylactic treatment of asthma.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 4 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Event (AE) or Adverse Drug Reaction (ADR) | Up to Week 12 | 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. |
| Number of Participants With Any Serious Adverse Event (SAE) or Non-SAE | Up to Week 12 | 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. |
| Number of Participants With Any New, Unexpected AE or Safety Signal | Up to Week 12 | 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. |
Countries
China
Participant flow
Recruitment details
This was a single arm non-interventional, post-marketing safety monitoring study to evaluate safety of Chinese participants aged 1 to \<4 years when using Flixotide 50 micrograms (μg) via a pediatric spacer device with a face mask in clinical practice. No medical intervention was received by participants during conduct of this study.
Pre-assignment details
Total 158 participants were enrolled into this study. The study was conducted at 4 centers in China.
Participants by arm
| Arm | Count |
|---|---|
| All Participants The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study. | 158 |
| Total | 158 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Participant refused to use the drug | 2 |
| Overall Study | Participant relative refused to use drug | 1 |
| Overall Study | Unwillingness of the guardian | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 33.40 Months STANDARD_DEVIATION 10.98 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment China China | 158 Participants | — |
| Sex: Female, Male Female | 58 Participants | — |
| Sex: Female, Male Male | 100 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 158 |
| other Total, other adverse events | 104 / 158 |
| serious Total, serious adverse events | 6 / 158 |
Outcome results
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.
Time frame: Up to Week 12
Population: Safety Analysis Population. It was defined as all the participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants With Any Adverse Event (AE) or Adverse Drug Reaction (ADR) | Any AE | 110 Participants |
| All Participants | Number of Participants With Any Adverse Event (AE) or Adverse Drug Reaction (ADR) | Any ADR | 0 Participants |
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.
Time frame: Up to Week 12
Population: Safety Analysis Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants With Any New, Unexpected AE or Safety Signal | Any unexpected AE | 0 Participants |
| All Participants | Number of Participants With Any New, Unexpected AE or Safety Signal | Any safety signal | 0 Participants |
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.
Time frame: Up to Week 12
Population: Safety Analysis Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants With Any Serious Adverse Event (SAE) or Non-SAE | Any non-SAE | 104 Participants |
| All Participants | Number of Participants With Any Serious Adverse Event (SAE) or Non-SAE | Any SAE | 6 Participants |