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

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ClinicalTrials.gov Identifier: NCT03219255
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: RELVAR 100 ELLIPTA

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relvar 100 Ellipta Special Drug Use Investigation (COPD, Long-term)
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

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): NCT03219255


Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Japan
GSK Investigational Site Not yet recruiting
Hokkaido, Japan, 003-0825
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Kanagawa, Japan, 211-0025
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03219255     History of Changes
Other Study ID Numbers: 205653
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by GlaxoSmithKline:
Post-marketing
Chronic obstructive pulmonary disease
Drug use investigation
RELVAR 100 ELLIPTA

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive