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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving fluticasone propionate | Eligible subjects will receive FP 50 µg twice daily inhaled via a pediatric pMDI with a face mask in clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate | Drug | Fluticasone propionate is an inhaled corticosteroid to be used via a pediatric spacer device with a face mask for prophylactic treatment of asthma. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
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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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Shenzhen | Guangdong | 518038 | China | ||
| GSK Investigational Site |
Total 158 participants were enrolled into this study. The study was conducted at 4 centers in China.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Up to Week 12 |
|
In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study.
Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2017 | Sep 3, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Shanghai |
| 200040 |
| China |
| GSK Investigational Site | Shanghai | 200092 | China |
| GSK Investigational Site | Shanghai | 200127 | China |
| Participant relative refused to use drug |
|
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Region of Enrollment is reported. | Count of Participants | 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. | Safety Analysis Population | Posted | Count of Participants | Participants | 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. | Safety Analysis Population | Posted | Count of Participants | Participants | Up to Week 12 |
|
|
|
| 0 |
| 158 |
| 6 |
| 158 |
| 104 |
| 158 |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Herpangina | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Rhinopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Mycoplasma infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Herpes pharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Molluscum contagious | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Sensation of foreign body | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Pain abdominal | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Stomach inflammation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Urticarial rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Coughing | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Balanoposthitis | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abnormal hepatic function | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Red blood cells urine | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ankyloglossia congenital | Congenital, familial and genetic disorders | MedDRA 20.1 | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |