AsthmaNCT03595930
Post-marketing Surveillance (PMS) Study to Observe the Safety and Effectiveness of ARNUITY in Asthma Subjects in a Real World Setting
An observational study of Asthma, run by GlaxoSmithKline at 1 site in South Korea.
Trial summary
This is an open-label, multi-center, PMS study to observe the safety and effectiveness of ARNUITY administered in asthma subjects in a real world setting. This PMS shall observe how a broad range of subjects use the drug in the early stages after obtaining the approval. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Arnuity
- How many people
- 668 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Sep 2018to 22 Jul 2020
- How long will I take part?
- 22 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This PMS will be conducted with subjects who were administered ARNUITY in accordance with the approved label. The safety analysis population shall consist of subjects who have administered at least one dose of ARNUITY and have received at least one safety assessment. The effectiveness analysis population shall consist of subjects who have completed the physician's effectiveness assessment (i.e., improved, unchanged, exacerbated, or un-assessable) based on the results of the pulmonary function test or asthma symptom control after administering ARNUITY for 24 weeks (or longer).
Who may be able to join
- Pediatric subjects older than 12 years of age and adult subjects with asthma
- Subjects who will administer ARNUITY in accordance with the product information approved in Korea
- Subjects who have signed the informed consent form for the PMS
Who cannot join
- Subjects with status asthmaticus or subjects who have administered ARNUITY as primary therapy for other acute asthmatic episodes that require intensive treatment
- Subjects who have any known hyper-sensitivity to the drug or its ingredients
- Subjects who have severe hypersensitive reactions to milk proteins
- Subjects with hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Multi-centre, Post Marketing Surveillance to Observe the Safety and Effectiveness of ARNUITY Administered in Patients With Asthma in Usual Practice
This is an open-label, multi-center, PMS study to observe the safety and effectiveness of ARNUITY administered in asthma subjects in a real world setting. This PMS shall observe how a broad range of subjects use the drug in the early stages after obtaining the approval. The objective of this PMS is to collect safety and effectiveness data on ARNUITY's approved label in a real world setting. Total of 600 subjects shall be recruited throughout the PMS period; 01 Sep, 2018 to 30 June 2020. ARNUITY is the registered trademark of GSK group of companies.
- Conditions
- Asthma
- Being tested
- Arnuity
- Keywords
- ARNUITY, Effectiveness, Asthma, Post-marketing surveillance, Safety
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArnuityDrug
ARNUITY consist of Fluticasone Furoate, is an Inhaled corticosteroids (ICS) medicine taken as one inhalation, once daily, for the control and prevention of asthma in adults and children aged 12 years and older.
| Study group | Role | What they receive |
|---|---|---|
| Subjects who received ARNUITY | This PMS will be conducted with subjects who were administered ARNUITY in accordance with the approved label. Receives: Drug: Arnuity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of adverse events (AEs) after ARNUITY administration
An AE is defined as any undesirable, unintended signs (e.g., abnormal laboratory findings), symptoms, or disease that may occur after administration or during use of the product, and does not necessarily have to have a causal relationship with the product.
Measured: Up to 22months
Incidence rates of unexpected AEs and adverse drug reactions (ADRs)
An ADR is defined as an adverse event whose causal relationship with the product cannot be ruled out.
Measured: Up to 22 months
Incidence rates of serious AEs (SAEs) and serious ADRs (SADRs)
A SAE refers to any one of the following adverse events, which: results in death or is life-threatening; results in or prolongs hospitalization; results in persistent or serious disability or incapacity; results in a birth defect or anomaly; or is an important medical event. SADR is defined a SAE whose causal relationship with the product cannot be ruled out.
Measured: Up to 22 months
Number of subjects with abnormal findings as assessed by physician's effectiveness assessment
For the subjective assessment of effectiveness, the physicians shall assess physician's effectiveness assessment at Week 24 after administration of Arnuity, based on the pulmonary function test and/or asthma symptom control.
Measured: Week 24
Change in Forced Expiratory Volume in 1 Second (FEV1) before and after ARNUITY administration
The physicians shall collect FEV1 data at Week 0 and Week 24 after Arnuity administration. The change in the FEV1 results before and after administration of the product shall be analyzed using a paired t-test.
Measured: Week 0, Week 24
Change in Forced Vital Capacity (FVC) before and after ARNUITY administration
The physicians shall collect FVC data at Week 0 and Week 24 after Arnuity administration. The change in the FVC results before and after administration of the product shall be analyzed using a paired t-test.
Measured: Week 0, Week 24
Change in FEV1/FVC ratio before and after ARNUITY administration
The physicians shall collect FEV1/FVC data at Week 0 and Week 24 after Arnuity administration. The change in the FEV1/ FVC ratio before and after administration of the product shall be analyzed using a paired t-test
Measured: Week 0, Week 24
Changes in the asthma symptom control results before and after ARNUITY administration
The physician shall collect the asthma symptom control results at Week 0 and Week 24 after Arnuity administration, based on the symptoms the subjects experienced for the past 4 weeks. The results of the asthma symptom control shall be categorized into 'Controlled', 'Partly Controlled', and 'Uncontrolled'.
Measured: Week 0, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start21 Sep 2018
- Primary completion22 Jul 2020
- Study completion22 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 668 participants (actual)
- Target duration
- 22 Months
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595930
- Sponsor's protocol ID
- 207435
- Status last verified
- Aug 2020
- First submitted
- 12 Jul 2018
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-centre, Post Marketing Surveillance to Observe the Safety and Effectiveness of ARNUITY Administered in Patients With Asthma in Usual Practice
- ClinicalTrials.gov ID
- NCT03595930
- Acronym / sponsor ID
- 207435
- Conditions
- Asthma
- Keywords
- ARNUITY, Effectiveness, Asthma, Post-marketing surveillance, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 668 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 22 Jul 2020 (actual)
- Study completion
- 22 Jul 2020 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multi-center, PMS study to observe the safety and effectiveness of ARNUITY administered in asthma subjects in a real world setting. This PMS shall observe how a broad range of subjects use the drug in the early stages after obtaining the approval. The objective of this PMS is to collect safety and effectiveness data on ARNUITY's approved label in a real world setting. Total of 600 subjects shall be recruited throughout the PMS period; 01 Sep, 2018 to 30 June 2020. ARNUITY is the registered trademark of GSK group of companies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 22 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects who received ARNUITY | – | Drug: ArnuityThis PMS will be conducted with subjects who were administered ARNUITY in accordance with the approved label. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This PMS will be conducted with subjects who were administered ARNUITY in accordance with the approved label. The safety analysis population shall consist of subjects who have administered at least one dose of ARNUITY and have received at least one safety assessment. The effectiveness analysis population shall consist of subjects who have completed the physician's effectiveness assessment (i.e., improved, unchanged, exacerbated, or un-assessable) based on the results of the pulmonary function test or asthma symptom control after administering ARNUITY for 24 weeks (or longer).
Key inclusion criteria (3 listed)
- Pediatric subjects older than 12 years of age and adult subjects with asthma
- Subjects who will administer ARNUITY in accordance with the product information approved in Korea
- Subjects who have signed the informed consent form for the PMS
Key exclusion criteria (4 listed)
- Subjects with status asthmaticus or subjects who have administered ARNUITY as primary therapy for other acute asthmatic episodes that require intensive treatment
- Subjects who have any known hyper-sensitivity to the drug or its ingredients
- Subjects who have severe hypersensitive reactions to milk proteins
- Subjects with hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArnuityARNUITY consist of Fluticasone Furoate, is an Inhaled corticosteroids (ICS) medicine taken as one inhalation, once daily, for the control and prevention of asthma in adults and children aged 12 years and older. | Drug | Subjects who received ARNUITY |
Primary outcome
Incidence rate of adverse events (AEs) after ARNUITY administration
Time frame: Up to 22months
An AE is defined as any undesirable, unintended signs (e.g., abnormal laboratory findings), symptoms, or disease that may occur after administration or during use of the product, and does not necessarily have to have a causal relationship with the product.
Incidence rates of unexpected AEs and adverse drug reactions (ADRs)
Time frame: Up to 22 months
An ADR is defined as an adverse event whose causal relationship with the product cannot be ruled out.
Incidence rates of serious AEs (SAEs) and serious ADRs (SADRs)
Time frame: Up to 22 months
A SAE refers to any one of the following adverse events, which: results in death or is life-threatening; results in or prolongs hospitalization; results in persistent or serious disability or incapacity; results in a birth defect or anomaly; or is an important medical event. SADR is defined a SAE whose causal relationship with the product cannot be ruled out.
Number of subjects with abnormal findings as assessed by physician's effectiveness assessment
Time frame: Week 24
For the subjective assessment of effectiveness, the physicians shall assess physician's effectiveness assessment at Week 24 after administration of Arnuity, based on the pulmonary function test and/or asthma symptom control.
Change in Forced Expiratory Volume in 1 Second (FEV1) before and after ARNUITY administration
Time frame: Week 0, Week 24
The physicians shall collect FEV1 data at Week 0 and Week 24 after Arnuity administration. The change in the FEV1 results before and after administration of the product shall be analyzed using a paired t-test.
Change in Forced Vital Capacity (FVC) before and after ARNUITY administration
Time frame: Week 0, Week 24
The physicians shall collect FVC data at Week 0 and Week 24 after Arnuity administration. The change in the FVC results before and after administration of the product shall be analyzed using a paired t-test.
Change in FEV1/FVC ratio before and after ARNUITY administration
Time frame: Week 0, Week 24
The physicians shall collect FEV1/FVC data at Week 0 and Week 24 after Arnuity administration. The change in the FEV1/ FVC ratio before and after administration of the product shall be analyzed using a paired t-test
Changes in the asthma symptom control results before and after ARNUITY administration
Time frame: Week 0, Week 24
The physician shall collect the asthma symptom control results at Week 0 and Week 24 after Arnuity administration, based on the symptoms the subjects experienced for the past 4 weeks. The results of the asthma symptom control shall be categorized into 'Controlled', 'Partly Controlled', and 'Uncontrolled'.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by GlaxoSmithKline at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of adverse events (AEs) after ARNUITY administration (time frame: Up to 22months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.