An observational study in Asthma, sponsored by GlaxoSmithKline. Completed at 4 sites in China. Open to participants aged 1 Year to 4 Years. Per ClinicalTrials.gov, last updated 2019-10-02.
Sponsored by GlaxoSmithKline · Observational
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Among 261 studies in Asthma by GlaxoSmithKline — 7 open to participants now, 12 under way, 7 of them phase 3. Asthma · GlaxoSmithKline.
Among the 261 studies in Asthma by GlaxoSmithKline, this one is the 18th largest by enrollment of the 24 observational ones that give a count, is one of 9 that started in 2018, is one of 24 observational ones, and was the 221st registered.
4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.
Browse Asthma studies →7 of the 261 studies in Asthma by GlaxoSmithKline are open now, in 12 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in United States, Argentina, Canada and 1 more country
Ages 18+
GlaxoSmithKline · Sites in United States
Ages 12–80
GlaxoSmithKline · Sites in United States, Japan
Ages 12–80
GlaxoSmithKline · Sites in United States
Ages 6–11
GlaxoSmithKline · Sites in United States, United Kingdom
Ages 12+
By country, each count listing its studies:
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 147 take children under 18; 105 take healthy volunteers.
This study: 1 Year to 4 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
261 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 63 · Phase 2 59 · Phase 3 61 · Phase 4 53
First in 1999; this study’s year is marked. 9 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 158 is close to the median of 159 across 1,252 observational studies indexed under Asthma.
Median enrollment 100 across the 237 interventional studies, 512 across the 24 observational. Of the 239 that completed or were terminated, 131 (55%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
5 of the studies in Asthma by GlaxoSmithKline that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07645248Phase 3GlaxoSmithKlineA Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a) | 2026-12-28 |
| NCT05757102Phase 3GlaxoSmithKlineA Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma | 2027-01-26 |
| NCT07671001Phase 3GlaxoSmithKlineA Study of Depemokimab in Participants of 6 to 11 Years of Age | 2027-03-01 |
| NCT07712393GlaxoSmithKlineA Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283 | 2027-04-13 |
| NCT06433921GlaxoSmithKlineA Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive | 2027-04-16 |
Add all 5 to your calendar (.ics) → With an account.
Among the 261 studies in Asthma by GlaxoSmithKline, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Exclusion Criteria:
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible subjects will receive FP 50 µg twice daily inhaled via a pediatric pMDI with a face mask in clinical practice.
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.
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
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
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
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.
| Milestone | All Participants |
|---|---|
| Started | 158 |
| Completed | 149 |
| Not completed | 9 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Unwillingness of the guardian | 1 |
| Withdrew: Participant refused to use the drug | 2 |
| Withdrew: Participant relative refused to use drug | 1 |
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.
| Participants | All Participants |
|---|---|
| Any AE | 110 |
| Any ADR | 0 |
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.
| Participants | All Participants |
|---|---|
| Any non-SAE | 104 |
| Any SAE | 6 |
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.
| Participants | All Participants |
|---|---|
| Any unexpected AE | 0 |
| Any safety signal | 0 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | 0/158 (0%) | 6/158 (3.8%) | 104/158 (65.8%) |
| Event | All Participants |
|---|---|
| PneumoniaInfections and infestations | 4/158 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 2/158 |
| Event | All Participants |
|---|---|
| Upper respiratory tract infectionInfections and infestations | 47/158 |
| BronchitisInfections and infestations | 34/158 |
| PyrexiaGeneral disorders | 32/158 |
| RhinitisInfections and infestations | 9/158 |
| PharyngitisInfections and infestations | 8/158 |
| HerpanginaInfections and infestations | 8/158 |
| DiarrhoeaGastrointestinal disorders | 5/158 |
| VomitingGastrointestinal disorders | 5/158 |
| DermatitisSkin and subcutaneous tissue disorders | 5/158 |
| RhinopharyngitisInfections and infestations | 4/158 |
| Age, Continuous(Months) | All Participants |
|---|---|
| Mean | 33.40 ± 10.98 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 58 |
| Male | 100 |
| Race and Ethnicity Not Collected(Participants) | All Participants |
|---|
| Region of Enrollment(Participants) | All Participants |
|---|---|
| China — China | 158 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2018 to primary completion in Sep 2018, 8 months.
Results were first posted in Oct 2019, 1 year after primary completion.
Of 90 industry-sponsored observational studies under Asthma, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 58. This study's 8 months is below that.
Counting every sponsor, half of 455 studies reached it within 36 months; a quarter within 18 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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