RELVAR® 100 ELLIPTA® Special Drug Use Investigation (COPD, Long-term)

July 26, 2021 updated by: GlaxoSmithKline

Relvar 100 Ellipta Special Drug Use Investigation (COPD, Long-term)

This study aims to investigate the long-term safety and efficacy of RELVAR® 100 ELLIPTA® (hereinafter referred to as "Relvar") in daily clinical practice in subjects with chronic obstructive pulmonary disease (COPD), who are naive to RELVAR. A total of 1000 subjects, from approximately 200 medical institutions, will be registered for this study and 332 of them will be considered for safety analysis. In the investigation, subject registration and data collection will be conducted using an Electronic Data Capture (EDC) system. Post-registration, the investigator will monitor the information regarding the safety and efficacy of RELVAR for one year from the start date of treatment with RELVAR. Pneumonia, systemic effects caused by corticosteroids and cardiovascular events will be considered as the priority investigation matters. At the end of observation period, the investigator will enter the obtained information into the EDC system and submit it. RELVAR 100 ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1047

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

  • Japan
      • Hokkaido, Japan, 003-0825
        • GSK Investigational Site
      • Kanagawa, Japan, 211-0025
        • GSK Investigational Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study will assess and collect the information about safety and effectiveness of RELVAR in approximately 1000 subjects with COPD (bronchitis chronic/emphysema), for which RELVAR is indicated, who are naïve to RELVAR.

Description

Inclusion Criteria:

  • Subjects with a diagnosis of COPD (bronchitis chronic/emphysema) and who are naive to RELVAR will be included.

Exclusion Criteria:

  • Among subjects with concomitant asthma, subjects with experience of taking RELVAR for treatment of asthma will be excluded from the investigation.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Subjects receiving RELVAR 100 ELLIPTA
Subjects with a diagnosis of COPD, for which RELVAR is indicated, who are naive to RELVAR will be included.
Drug: RELVAR 100 ELLIPTA
RELVAR 100 ELLIPTA contains fluticasone furoate, an inhaled corticosteroid and vilanterol, an ultra-long-acting Beta-2 agonist and it is indicated for the treatment of COPD (bronchitis chronic/emphysema). Post-marketing investigation of RELVAR 100 ELLIPTA will be carried out in this analysis.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of subjects with adverse events (AEs), serious adverse events (SAEs) and drug related AEs
Time Frame: One year from the start of RELVAR treatment
The investigator will collect the information about all AEs (e.g., a disease, symptom, abnormal laboratory value) occurring after the start of RELVAR administration, regardless of whether or not RELVAR is related to an AE. The AEs assessed as 'related' to RELVAR will be handled as adverse drug reactions (ADRs).
One year from the start of RELVAR treatment
Number of subjects with pneumonia, systemic effects caused by corticosteroids and cardiovascular events
Time Frame: One year from the start of RELVAR treatment
Pneumonia, systemic effects such as suppression of adrenal cortical function, bone disorders, eye disorders, etc. caused by corticosteroids and cardiovascular events will be considered as priority investigation matter for this investigation and its occurrence will be monitored throughout the study period.
One year from the start of RELVAR treatment
Efficacy rate based on global efficacy assessment
Time Frame: One year from the start of RELVAR treatment
The efficacy rate is the proportion of subjects assessed as "effective." Efficacy will be globally assessed based on the courses of subjective and clinical symptoms, COPD exacerbation, changes in values for respiratory function tests, change in COPD assessment test (CAT) scores, etc. during the period between the start date of treatment and the end of the observation period.
One year from the start of RELVAR treatment
Time to COPD exacerbation
Time Frame: One year from the start of RELVAR treatment
The COPD exacerbations are episodes, which may refer to an increase in the severity of disease or its sign and symptoms. The presence or absence of exacerbation for one year before and after the start of treatment with RELVAR (or at the time of withdrawal/ termination), presence or absence of hospitalization, treatment with antimicrobial agents and/or systemic steroids and exacerbation not corresponding to the above-mentioned parameters in each exacerbation episode will be determined.
One year from the start of RELVAR treatment
Change from Baseline in CAT score
Time Frame: Baseline and up to one year from the start of RELVAR treatment
The CAT is a questionnaire designed to measure the impact of COPD on subject's life and how it changes over time. Investigator will record the information of CAT completed by subjects at the start of treatment with RELVAR, Month 3 and Year 1 or at the time of withdrawal/termination.
Baseline and up to one year from the start of RELVAR treatment
Change from Baseline in forced expiratory volume in 1 second (FEV1)
Time Frame: Baseline and up to one year from the start of RELVAR treatment
Respiratory function test will be performed by spirometry. Information regarding presence or absence of tests, date of tests, presence or absence of short-acting Beta-2 agonists within four hours before measurement, and FEV1 at the start of treatment with RELVAR, Month 3 and Year 1 or at the time of withdrawal/termination will be collected.
Baseline and up to one year from the start of RELVAR treatment
Change from Baseline in forced vital capacity (FVC)
Time Frame: Baseline and up to one year from the start of RELVAR treatment
Respiratory function test will be performed by spirometry. Information regarding presence or absence of tests, date of tests, presence or absence of short-acting Beta-2 agonists within four hours before measurement, and FVC at the start of treatment with RELVAR, Month 3 and Year 1 or at the time of withdrawal/termination will be collected.
Baseline and up to one year from the start of RELVAR treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 205653

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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