Trial Outcomes & Findings for Ease of Use and Correct Use Study of Placebo ELLIPTA® Inhaler in COPD Subjects (NCT NCT02586493)

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. The percentage is based off the number of participants analyzed i.e the number of subjects in the MITT population (subjects who received a dose of study medication and were randomised).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

278 participants

Primary outcome timeframe

Day 30

Results posted on

2017-11-09

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 Chronic Obstructive Pulmonary Disease (COPD) 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 COPD 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.
Overall Study STARTED	278
Overall Study COMPLETED	266
Overall Study NOT COMPLETED	12

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 COPD 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.
Overall Study Adverse Event	4
Overall Study Protocol Violation	6
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Ease of Use and Correct Use Study of Placebo ELLIPTA® Inhaler in COPD Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo ELLIPTA Inhaler n=278 Participants Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD 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.
Age, Continuous	64.8 Years STANDARD_DEVIATION 8.56 • n=5 Participants
Sex: Female, Male Female	131 Participants n=5 Participants
Sex: Female, Male Male	147 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	28 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	1 Participants n=5 Participants
Race/Ethnicity, Customized White-White/Caucasian/European Heritage	249 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30

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. Only participants with data available at the analysis time point were analyzed.

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. The percentage is based off the number of participants analyzed i.e the number of subjects in the MITT population (subjects who received a dose of study medication and were randomised).

Outcome measures

Outcome measures
Measure	Placebo ELLIPTA Inhaler n=266 Participants Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD 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.
Percentage of Participants With COPD Who Rate the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrate Correct Use of the Inhaler at the End of the Study.	93 Percentage Interval 90.0 to 96.0

SECONDARY outcome

Timeframe: Day 30

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=266 Participants Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD 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.
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 of Participants Interval 97.0 to 100.0

SECONDARY outcome

Timeframe: Day 30

Population: mITT Population

Participants' ability to correctly use the ELLIPTA inhaler was assessed at Visit 1 and 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=266 Participants Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD 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.
The Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA Inhaler at the End of the Study.	97 Percentage of Participants Interval 94.0 to 99.0

Adverse Events

Placebo ELLIPTA Inhaler

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo ELLIPTA Inhaler n=278 participants at risk Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD 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.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.4% 4/278 • 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)

Other adverse events

Adverse event data not reported

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