- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03273946
Post-marketing Safety Monitoring Program of Fluticasone Propionate (FP) in Chinese Subjects With Asthma Aged 1 to <4 Years
September 9, 2019 updated by: GlaxoSmithKline
Post-Marketing Observational Study to Evaluate Safety Profile of Flixotide 50 μg pMDI Treatment in Chinese Subjects With Asthma Aged 1-<4 Years
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
158
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai, China, 200040
- GSK Investigational Site
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Shanghai, China, 200092
- GSK Investigational Site
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Shanghai, China, 200127
- GSK Investigational Site
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Guangdong
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Shenzhen, Guangdong, China, 518038
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Fluticasone propionate is an inhaled corticosteroid to be used via a pediatric spacer device with a face mask for prophylactic treatment of asthma.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Any Adverse Event (AE) or Adverse Drug Reaction (ADR)
Time Frame: Up to Week 12
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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.
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Up to Week 12
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Number of Participants With Any Serious Adverse Event (SAE) or Non-SAE
Time Frame: Up to Week 12
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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.
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Up to Week 12
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Number of Participants With Any New, Unexpected AE or Safety Signal
Time Frame: Up to Week 12
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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.
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Up to Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 9, 2018
Primary Completion (Actual)
September 27, 2018
Study Completion (Actual)
September 27, 2018
Study Registration Dates
First Submitted
September 5, 2017
First Submitted That Met QC Criteria
September 5, 2017
First Posted (Actual)
September 6, 2017
Study Record Updates
Last Update Posted (Actual)
October 2, 2019
Last Update Submitted That Met QC Criteria
September 9, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Fluticasone
- Xhance
Other Study ID Numbers
- 207734
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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