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Trial record 94 of 185 for:    GLYCOPYRROLATE

Comparative Study of Error Rates Between ELLIPTA® Dry Powder Inhaler (DPI) and Other DPIs

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ClinicalTrials.gov Identifier: NCT03114969
Recruitment Status : Completed
First Posted : April 14, 2017
Results First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
For effective drug delivery using inhalation route, it is important to use the inhalers correctly. This open-label study will evaluate the error rates during the use of ELLIPTA DPI, alone or in combination, in comparison with other DPIs. The study aims to provide clinical evidence in subjects with COPD that the reduced number of steps required to use the ELLIPTA DPI could result in fewer errors made by subjects, and therefore a more consistent treatment. Approximately 450 subjects prescribed with either of RELVAR® ELLIPTA, ANORO® ELLIPTA, INCRUSE® ELLIPTA, SYMBICORT® TURBUHALER®, SERETIDE® DISKUS®, SPIRIVA® HANDIHALER®, ULTIBRO® BREEZHALER® or SEEBRI® BREEZHALER will be included in the study and will have 2 clinical visits. At Visit 1, subjects will take their maintenance DPIs and the critical and overall errors made by subjects will be assessed. After the assessment, subjects will be instructed on correct use or informed of their correct use of their DPIs. The total duration of the study is approximately 6 weeks. ELLIPTA, SERETIDE and DISKUS are registered trademarks of the GSK group of companies. SYMBICORT and TURBUHALER are registered trademarks of the AstraZeneca group of companies. SPIRIVA and HANDIHALER are registered trademarks of Boehringer Ingelheim Pharmaceuticals. ULTIBRO, BREEZHALER and SEEBRI are registered trademarks of the Novartis group of companies.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Device: Relvar ELLIPTA Device: Symbicort TURBUHALER Device: Seretide DISKUS Device: Spiriva HANDIHALER Device: BREEZHALER Device: Incruse ELLIPTA Device: Anoro ELLIPTA

Layout table for study information
Study Type : Observational
Actual Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Open-label, Low Interventional Clinical Study Investigating Error Rates (Critical and Overall) Prior to Any Retraining in Correct Use of the ELLIPTA Dry Powder Inhaler (DPI) Compared to Other DPIs Including; DISKUS, Turbuhaler, HandiHaler and Breezhaler as a Monotherapy or in Combination, in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date : June 8, 2017
Actual Primary Completion Date : March 9, 2018
Actual Study Completion Date : March 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Group/Cohort Intervention/treatment
Subjects using RELVAR ELLIPTA
Subjects with a fixed dose combination of inhaled corticosteroids/ long-acting beta agonists (ICS/LABA) via a single DPI of RELVAR ELLIPTA for treatment of COPD will be included.
Device: Relvar ELLIPTA
ELLIPTA inhaler containing Relvar will be used by subjects as their maintenance treatment to control COPD.

Subjects using SYMBICORT TURBUHALER
Subjects with a fixed dose combination of ICS/LABA via a single DPI of SYMBICORT TURBUHALER for treatment of COPD will be included.
Device: Symbicort TURBUHALER
TURBUHALER inhaler containing Symbicort will be used by subjects as their maintenance treatment to control COPD.

Subjects using SERETIDE DISKUS
Subjects with a fixed dose combination of ICS/LABA via a single DPI of SERETIDE DISKUS for treatment of COPD will be included.
Device: Seretide DISKUS
DISKUS inhaler containing Seretide will be used by subjects as their maintenance treatment to control COPD.

Subjects using SPIRIVA HANDIHALER
Subjects with a fixed dose monotherapy of long-acting muscarinic antagonists (LAMA) via a single DPI of SPIRIVA HANDIHALER for treatment of COPD will be included.
Device: Spiriva HANDIHALER
HANDIHALER inhaler containing Spiriva will be used by subjects as their maintenance treatment to control COPD.

Subjects using INCRUSE ELLIPTA or ANORO ELLIPTA
Subjects with a fixed dose monotherapy of LAMA via a single DPI of INCRUSE ELLIPTA or subjects taking a fixed dose combination of LAMA/LABA via a single DPI of ANORO ELLIPTA for treatment of COPD will be included.
Device: Incruse ELLIPTA
ELLIPTA inhaler containing Incruse will be used by subjects as their maintenance treatment to control COPD.

Device: Anoro ELLIPTA
ELLIPTA inhaler containing Anoro will be used by subjects as their maintenance treatment to control COPD.

Subjects using SEEBRI BREEZHALER or ULTIBRO BREEZHALER
Subjects with a fixed dose monotherapy of LAMA via a single DPI of SEEBRI BREEZHALER or subjects taking a fixed dose combination of LAMA/LABA via a single DPI of ULTIBRO BREEZHALER for treatment of COPD will be included.
Device: BREEZHALER
BREEZHALER inhaler containing either Seebri or Ultibro will be used by subjects as their maintenance treatment to control COPD.

Subjects using RELVAR ELLIPTA with HANDIHALER/ INCRUSE ELLIPTA
Subjects with a fixed dose combination of ICS/LABA via RELVAR ELLIPTA along with a fixed dose of LAMA via SPIRIVA HANDIHALER or INCRUSE ELLIPTA will be included.
Device: Relvar ELLIPTA
ELLIPTA inhaler containing Relvar will be used by subjects as their maintenance treatment to control COPD.

Device: Spiriva HANDIHALER
HANDIHALER inhaler containing Spiriva will be used by subjects as their maintenance treatment to control COPD.

Device: Incruse ELLIPTA
ELLIPTA inhaler containing Incruse will be used by subjects as their maintenance treatment to control COPD.

Subjects using TURBUHALER with HANDIHALER/INCRUSE ELLIPTA
Subjects with a fixed dose combination of ICS/LABA via SYMBICORT TURBUHALER along with a fixed dose of LAMA via SPIRIVA HANDIHALER or INCRUSE ELLIPTA will be included.
Device: Symbicort TURBUHALER
TURBUHALER inhaler containing Symbicort will be used by subjects as their maintenance treatment to control COPD.

Device: Spiriva HANDIHALER
HANDIHALER inhaler containing Spiriva will be used by subjects as their maintenance treatment to control COPD.

Device: Incruse ELLIPTA
ELLIPTA inhaler containing Incruse will be used by subjects as their maintenance treatment to control COPD.

Subjects using DISKUS with HANDIHALER/INCRUSE ELLIPTA
Subjects with a fixed dose combination of ICS/LABA via SERETIDE DISKUS along with a fixed dose of LAMA via SPIRIVA HANDIHALER or INCRUSE ELLIPTA will be included.
Device: Seretide DISKUS
DISKUS inhaler containing Seretide will be used by subjects as their maintenance treatment to control COPD.

Device: Spiriva HANDIHALER
HANDIHALER inhaler containing Spiriva will be used by subjects as their maintenance treatment to control COPD.

Device: Incruse ELLIPTA
ELLIPTA inhaler containing Incruse will be used by subjects as their maintenance treatment to control COPD.




Primary Outcome Measures :
  1. Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons [ Time Frame: Day 1 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the health care practitioner (HCP) in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in patient instruction leaflets (PILs) for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The analysis was performed on the Intent to Treat (ITT) Population which comprised of all enrolled participants who demonstrated use of their primary DPI.

  2. Percentage of Participants Making at Least One Critical Error at Visit 1 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) [ Time Frame: Day 1 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and reporting and analysis plan (RAP).

  3. Percentage of Participants Making at Least One Critical Error at Visit 1 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI [ Time Frame: Day 1 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.

  4. Percentage of Participants Making at Least One Critical Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA) [ Time Frame: Day 1 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented.

  5. Percentage of Participants Making at Least One Critical Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) [ Time Frame: Day 1 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.

  6. Percentage of Participants Making at Least One Critical Error at Visit 1-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI) [ Time Frame: Day 1 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.


Secondary Outcome Measures :
  1. Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons [ Time Frame: Day 1 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants with at least one overall error in the primary DPI is presented.

  2. Percentage of Participants Making at Least One Overall Error at Visit 1 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) [ Time Frame: Day 1 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants with at least one overall error in primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.

  3. Percentage of Participants Making at Least One Overall Error at Visit 1 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI [ Time Frame: Day 1 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants with at least one overall error in primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.

  4. Percentage of Participants Making at Least One Overall Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA) [ Time Frame: Day 1 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making at least one overall error in either one or both devices (where applicable) is presented.

  5. Percentage of Participants Making at Least One Overall Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) [ Time Frame: Day 1 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. Errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. Percentage of participants making at least one overall error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.

  6. Percentage of Participants Making at Least One Overall Error at Visit 1-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI) [ Time Frame: Day 1 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. Errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. Percentage of participants making at least one overall error in either one or both devices (where applicable) is presented.The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.

  7. Percentage of Participants Making at Least One Critical Error at Visit 2-Primary Device Comparisons [ Time Frame: Week 6 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented.

  8. Percentage of Participants Making at Least One Critical Error at Visit 2 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) [ Time Frame: Week 6 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.

  9. Percentage of Participants Making at Least One Critical Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI [ Time Frame: Week 6 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.

  10. Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA) [ Time Frame: Week 6 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented.

  11. Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) [ Time Frame: Week 6 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.

  12. Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI) [ Time Frame: Week 6 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.

  13. Percentage of Participants Making at Least One Overall Error at Visit 2-Primary Device Comparisons [ Time Frame: Week 6 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making at least one overall error in the primary DPI is presented.

  14. Percentage of Participants Making at Least One Overall Error at Visit 2 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) [ Time Frame: Week 6 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps listed in PILs for the respective DPI. The errors were defined as "critical", when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making at least one overall error in primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.

  15. Percentage of Participants Making at Least One Overall Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI [ Time Frame: Week 6 ]

    Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps listed in PILs for the respective DPI. The errors were defined as "critical", when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making at least one overall error in primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.

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  16. Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA) [ Time Frame: Week 6 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making at least one overall error in either one or both devices (where applicable) is presented.

  17. Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) [ Time Frame: Week 6 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on correct use of inhalers. Any error made by the participant was recorded by HCP in the checklist. Checklist of instructions for correct use were based on steps for correct use listed in PILs for the respective DPI. Errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per PIL. Overall errors is the combination of critical and non-critical errors. Percentage of participants making at least one overall error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.

  18. Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI) [ Time Frame: Week 6 ]
    Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with chronic obstructive pulmonary disease and uses a dry powder inhaler
Criteria

Inclusion Criteria:

  • Subjects with documented Physician's diagnosis of COPD, and currently receiving maintenance therapy.
  • Aged >=40 years of age at inclusion.
  • Using one of the maintenance therapies of interest for at least 3 months prior to inclusion on the study.
  • Males or females.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in the protocol.

Exclusion Criteria:

  • Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD.
  • Drug/alcohol abuse: Subjects with a known or suspected alcohol or drug abuse history at screening (Visit 0) that in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirement.
  • Investigational product: Subjects who have received an investigational drug and/or medical device within 30 days of entry into this study (Screening/Visit 1), or within five half-lives of the investigational drug, whichever is longer.
  • Investigational product: Subjects who have been trained during participation in any device study in the 6 months prior to entry into this study.

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): NCT03114969


Locations
Layout table for location information
Netherlands
GSK Investigational Site
Beek En Donk, Netherlands, 5741 CG
GSK Investigational Site
Beek, Netherlands, 6191JW
GSK Investigational Site
Eindhoven, Netherlands, 5623 EJ
GSK Investigational Site
Hengelo, Netherlands, 7555 DL
GSK Investigational Site
Hoorn, Netherlands, 1624 NP
GSK Investigational Site
Kloosterhaar, Netherlands, 7694 AC
GSK Investigational Site
Nijverdal, Netherlands, 7442 LS
GSK Investigational Site
Rotterdam, Netherlands, 3051 GV
GSK Investigational Site
Zutphen, Netherlands, 7207 AE
United Kingdom
GSK Investigational Site
Northwood, Middlesex, United Kingdom, HA6 2RN
GSK Investigational Site
London, United Kingdom, EC1M 6BQ
GSK Investigational Site
London, United Kingdom, SW17 0QT
GSK Investigational Site
Sidcup, Kent, United Kingdom, DA14 6LT
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] January 24, 2017
Statistical Analysis Plan  [PDF] April 26, 2018


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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03114969     History of Changes
Other Study ID Numbers: 204981
First Posted: April 14, 2017    Key Record Dates
Results First Posted: June 10, 2019
Last Update Posted: June 10, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Overall error
Error rate
Critical error
COPD
ELLIPTA
Dry powder inhaler
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Budesonide, Formoterol Fumarate Drug Combination
Fluticasone-Salmeterol Drug Combination
Tiotropium Bromide
Anti-Asthmatic Agents
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action