Trial Outcomes & Findings for Study of the Ease of Use and Correct Use of Placebo ELLIPTA® Inhaler in Subjects With Asthma (NCT NCT02586506)

Last Updated: 2017-10-11

Results Overview

Participants rated how easy it was to use the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). "Easy to use" was defined as the combination of an "easy" or "very easy" rating choice. The percentage was reported overall for the single treatment group along with a 95% confidence interval (CI) for the percentage calculated using the exact binomial distribution.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

259 participants

Primary outcome timeframe

Day 28

Results posted on

2017-10-11

Participant Flow

Participants who were naive to ELLIPTA (trade name of dry powder inhaler owned by GlaxoSmithKline) inhaler use and had an established diagnosis of asthma participated in this study.

Participant milestones

Participant milestones
Measure	Placebo ELLIPTA Inhaler Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A \& B have the same questions and in the same order, they only differ with response sequence.
Overall Study STARTED	259
Overall Study COMPLETED	250
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo ELLIPTA Inhaler Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A \& B have the same questions and in the same order, they only differ with response sequence.
Overall Study Protocol Violation	6
Overall Study Lost to Follow-up	1
Overall Study Other Reason	2

Baseline Characteristics

Study of the Ease of Use and Correct Use of Placebo ELLIPTA® Inhaler in Subjects With Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo ELLIPTA Inhaler n=259 Participants Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A \& B have the same questions and in the same order, they only differ with response sequence.
Age, Continuous	47.3 Years STANDARD_DEVIATION 15.23 • n=5 Participants
Sex: Female, Male Female	165 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	64 Participants n=5 Participants
Race (NIH/OMB) White	184 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 28

Population: Modified Intent-to-Treat (mITT) Population: all participants who were screened and received at least one dose of study treatment (placebo) and were randomised to receive the ELLIPTA inhaler ease of use questionnaire version A or B at Visit 2.

Outcome measures

Outcome measures
Measure	Placebo ELLIPTA Inhaler n=250 Participants Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A \& B have the same questions and in the same order, they only differ with response sequence.
The Percentage of Participants With Asthma Who Rated the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrated Correct Use of the Inhaler at the End of the Study.	96 Percentage Interval 92.0 to 98.0

SECONDARY outcome

Timeframe: Day 28

Population: mITT Population

Participants rated how easy it was to determine how many doses were left in the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). "Easy to use" was defined as the combination of an "easy" or "very easy" rating choice. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.

Outcome measures

Outcome measures
Measure	Placebo ELLIPTA Inhaler n=250 Participants Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A \& B have the same questions and in the same order, they only differ with response sequence.
The Percentage of Participants Who Rated the Ability to Tell How Many Doses Were Remaining in the ELLIPTA Inhaler as Easy or Very Easy at the End of the Study	99 Percentage Interval 97.0 to 100.0

SECONDARY outcome

Timeframe: Day 28

Population: mITT Population

Participants' ability to correctly use the ELLIPTA inhaler was assessed at Visit 2 using the Correct Use Checklist by an ELLIPTA trained health care professional. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.

Outcome measures

Outcome measures
Measure	Placebo ELLIPTA Inhaler n=250 Participants Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A \& B have the same questions and in the same order, they only differ with response sequence.
The Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA Inhaler at the End of the Study	98 Percentage Interval 95.0 to 99.0

Adverse Events

Placebo ELLIPTA Inhaler

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo ELLIPTA Inhaler n=259 participants at risk Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A \& B have the same questions and in the same order, they only differ with response sequence.
Nervous system disorders Headache	3.5% 9/259 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of Visit 1 until completion of Visit 2 (up to Day 30) The analysis population used for SAEs and non-serious AEs was Intent-to-Treat population: all participants who were screened and received at least one dose of study treatment (placebo)

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER