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Trial record 66 of 79879 for:    subjects

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

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ClinicalTrials.gov Identifier: NCT03273946
Recruitment Status : Completed
First Posted : September 6, 2017
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment
Asthma Drug: Fluticasone propionate

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Study Type : Observational
Actual Enrollment : 159 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 9, 2018
Actual Primary Completion Date : September 27, 2018
Actual Study Completion Date : September 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
Subjects receiving fluticasone propionate
Eligible subjects will receive FP 50 µg twice daily inhaled via a pediatric pMDI with a face mask.
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.




Primary Outcome Measures :
  1. Number of subjects with known adverse events (AEs) and serious AEs (SAEs) [ Time Frame: Up to Week 12 ]
    An AE is any untoward medical occurrence in a clinical study subjects, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.

  2. Number of subjects with unexpected AEs and SAEs [ Time Frame: Up to Week 12 ]
    An AE is any untoward medical occurrence in a clinical study subjects, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.



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Ages Eligible for Study:   1 Year to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273946


Locations
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China, Guangdong
GSK Investigational Site
Shenzhen, Guangdong, China, 518038
China
GSK Investigational Site
Shanghai, China, 200040
GSK Investigational Site
Shanghai, China, 200092
GSK Investigational Site
Shanghai, China, 200127
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03273946     History of Changes
Other Study ID Numbers: 207734
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
CCI18781
Observational
Post-marketing
Fluticasone propionate
Asthma

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents