18 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment PhasePrimary· Up to Day 56
A checklist for correct use of each inhaler was developed based on the steps identified in the package insert. Baseline assessment was conducted when the par were dispensed the inhaler and were guided by a trained healthcare provider (HCP) to demonstrate correct use of the assigned inhaler. A second assessment was conducted after each 28 day dosing period without instruction by HCP. The Correct Use Check list was completed by HCP at each visit. Percentage of par with zero errors in inhaler use at Day 28, was analyzed using a Mainland-Gart test for each ELLIPTA versus MDI comparison separately
ELLIPTA
Group
Value
95% CI
Sub-Study 1
87
Sub-Study 2
87
GSK MDI
Group
Value
95% CI
Sub-Study 1
13
Sub-Study 2
NA
AZ MDI
Group
Value
95% CI
Sub-Study 1
NA
Sub-Study 2
13
Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment PhaseSecondary· Up to Day 56
The occurrence of each type of error while using ELLIPTA inhaler was evaluated based on the information collected in the Correct Use Checklists. The number of errors for each type of inhaler was assessed at Visit 2 and Visit 3. The par were counted more than once depending on the reasons for incorrect use. Only par who made at least one error was included in the summary (represented by the number of Participants).
Par did shake the inhaler (ir)
Group
Value
95% CI
Sub-Study 1
3
Sub-Study 2
0
Par didn't exhale when ir was held away from mouth
Group
Value
95% CI
Sub-Study 1
2
Sub-Study 2
2
Par breathed into the mouthpiece (mp)
Group
Value
95% CI
Sub-Study 1
2
Sub-Study 2
0
Mp was not placed with lips closed around it
Group
Value
95% CI
Sub-Study 1
1
Sub-Study 2
0
Par did not take one long steady deep breath
Group
Value
95% CI
Sub-Study 1
1
Sub-Study 2
1
Par didn't remove ir from mouth and hold breath
Group
Value
95% CI
Sub-Study 1
1
Sub-Study 2
1
Par did not breathe out slowly and gently
Group
Value
95% CI
Sub-Study 1
1
Sub-Study 2
2
Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment PhaseSecondary· Up to Day 56
The occurrence of each type of error while using GSK MDI in Sub-Study 1 and AZ MDI in Sub-Study 2 was evaluated based on the information collected in the Correct Use Checklists. The number of errors for each type of inhaler was assessed at Visit 2 and Visit 3. The par were counted more than once depending on the reasons for incorrect use. The number of errors is reported as NA for the type of error which was not applicable to the particular inhaler type. Only par who made at least one error are included in the summary (represented by the number of Participants).
Par did not shake the inhaler
Group
Value
95% CI
Sub-Study 1
5
Sub-Study 2
5
Par did not check the mp for foreign objects
Group
Value
95% CI
Sub-Study 1
14
Sub-Study 2
9
Par did not hold the inhaler with the mp down
Group
Value
95% CI
Sub-Study 1
1
Sub-Study 2
NA
Par did not breathe out fully
Group
Value
95% CI
Sub-Study 1
5
Sub-Study 2
0
Mp was not placed with lips closed around it
Group
Value
95% CI
Sub-Study 1
2
Sub-Study 2
0
Par did not press top of canister all way down
Group
Value
95% CI
Sub-Study 1
2
Sub-Study 2
2
Ability to release actuation was not demonstrated
Group
Value
95% CI
Sub-Study 1
4
Sub-Study 2
2
Par did not take finger off the canister
Group
Value
95% CI
Sub-Study 1
3
Sub-Study 2
2
Number of Errors Per Participant for Each Inhaler After 28 Days of Use (All Evaluable Par)Secondary· Up to Day 56
The number of errors per par for each inhaler (ELLIPTA and GSK MDI or AZ MDI) was evaluated based on the information collected in the Correct Use Checklists. The number of errors per par was summarised as continuous data by inhaler for each of the ELLIPTA versus MDI comparisons. NA indicates that the par did not receive the inhaler in that particular sub-study.
ELLIPTA
Group
Value
95% CI
Sub-Study 1
0.07
± 0.393
Sub-Study 2
0.04
± 0.299
GSK MDI
Group
Value
95% CI
Sub-Study 1
0.35
± 1.139
Sub-Study 2
NA
± NA
AZ MDI
Group
Value
95% CI
Sub-Study 1
NA
± NA
Sub-Study 2
0.21
± 0.838
Number of Errors Per Participant for Each After 28 Days of Use (Par With at Least One Error)Secondary· Up to Day 56
The number of errors for each inhaler (ELLIPTA and GSK MDI or AZ MDI) in par with one or more errors were evaluated based on the information collected in the Correct Use Checklists. The number of errors per par was summarised as continuous data by inhaler for each of the ELLIPTA versus MDI comparisons. NA indicates that the par. did not receive the inhaler in that particular sub-study. Only those par who made at least one error were included in the summary (represented by n=X, X in the category titles).
ELLIPTA; n=7, 3
Group
Value
95% CI
Sub-Study 1
1.57
± 1.134
Sub-Study 2
2.00
± 1.000
GSK MDI; n=25, 0
Group
Value
95% CI
Sub-Study 1
2.20
± 2.062
AZ MDI; n=0, 14
Group
Value
95% CI
Sub-Study 2
2.29
± 1.773
Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment PhaseSecondary· Up to Day 56
A supportive post-hoc analysis on the primary endpoint was performed to address possible concerns due to the exclusion of data from a large number of participants who made no errors or at least one error on either inhaler tested in the primary analysis (only discordant cases involved in the analysis). For each ELLIPTA versus MDI comparison separately (Sub-study 1: Ellipta vs GSK MDI and Sub-study 2: Ellipta vs AZ MDI), the percentage of par having zero errors in inhaler use at Day 28 was analyzed using a Conditional Logistic Regression adjusting for treatment (inhaler) and treatment period. NA
Zero Errors after 28 Days of Use ELLIPTA
Group
Value
95% CI
Sub-Study 1
96
Sub-Study 2
98
Zero Errors after 28 Days of Use GSK MDI
Group
Value
95% CI
Sub-Study 1
84
Sub-Study 2
NA
Zero Errors after 28 Days of Use AZ MDI
Group
Value
95% CI
Sub-Study 1
NA
Sub-Study 2
91
At least one Error after 28 Days of Use ELLIPTA
Group
Value
95% CI
Sub-Study 1
4
Sub-Study 2
2
At least one Error after 28 Days of Use GSK MDI
Group
Value
95% CI
Sub-Study 1
16
Sub-Study 2
NA
At least one Error after 28 Days of Use AZ MDI
Group
Value
95% CI
Sub-Study 1
NA
Sub-Study 2
9
Adverse events — posted to ClinicalTrials.gov
Time frame: On-treatment adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow up visit (up to 58 days)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study is conducted to evaluate the potentially improved patient handling of the ELLIPTA Dry Powder Inhaler (DPI). Therefore, the study aims to evaluate errors encountered by subject with asthma during handling ELLIPTA DPI relative to two metered dose inhalers (MDI), a GSK MDI and the AstraZeneca (AZ) MDI. It is a randomised, multi-centre, open-label, cross-over study comparing placebo ELLIPTA DPI with placebo MDI (GSK and AZ) to assess correct inhaler use. No active drug will be used in this study in order to prevent any drug-related effects. Approximately, 152 subjects will be randomized to receive ELLIPTA DPI inhaler and 152 will be randomized to receive one of the MDI inhalers, for use during the first period (P) (approximately 28 days). At Visit 2 (Day 28) all subjects previous receiving the ELLIPTA DPI will be randomized to receive one of the MDI inhalers and all subjects who received a MDI in the previous period will receive the ELLIPTA DPI for use during second period (approximately 28 days). Subjects will continue taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
ELLIPTA is a registered trademark of the GSK group of companies.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 2 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02794480.