NCT02586493

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

Completed Phase 4 Results posted Last updated 9 November 2017

What this trial tests

Phase 4 trial testing Placebo in Pulmonary Disease, Chronic Obstructive in 278 participants. Completed in 15 March 2016.

Timeline

1 October 2015

Primary endpoint
1 March 2016

15 March 2016

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	278
Start date	1 October 2015
Primary completion	1 March 2016
Estimated completion	15 March 2016
Sites	16 locations across United States

Drugs / interventions tested

• Placebo
• Questionnaire

Conditions studied

• Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

40 and older, any sex, with Pulmonary Disease, Chronic Obstructive. 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 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. Primary · Day 30

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).

Group	Value	95% CI
Placebo ELLIPTA Inhaler	93	90 – 96

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. Secondary · Day 30

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.

Group	Value	95% CI
Placebo ELLIPTA Inhaler	99	97 – 100

The Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA Inhaler at the End of the Study. Secondary · Day 30

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.

Group	Value	95% CI
Placebo ELLIPTA Inhaler	97	94 – 99

Adverse events — posted to ClinicalTrials.gov

Time frame: 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). Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo ELLIPTA Inhaler

Serious: 4/278 (1%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	Placebo ELLIPTA Inhaler
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Chronic obstructive pulmonary disease.

Data from ClinicalTrials.gov NCT02586493 adverse events section.

Sponsor's own description

Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The mainstay for treatment involves the use of inhaled medications, including short and/or long-acting bronchodilators along with inhaled corticosteroids. For inhaled medications, the choice of inhalation device is an important consideration because an inadequate technique reduces the effects of inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to the lungs effectively, is important. This study will assess the correct use of the ELLIPTA inhaler by subjects with COPD and to assess ease of use of the ELLIPTA inhaler, as rated by those subjects determined to be using the inhaler correctly. Study will be divided into two visits i.e. Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day 8+/-2 days of Visit 1 to assess safety. In this multi-center, single-arm, randomised (to receive one of two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label, placebo study, only subjects who are have never used the ELLIPTA inhaler before and have an established diagnosis of COPD and receiving COPD therapy and are able to demonstrate correct use of the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this study. Approximately 252 subjects will be screened with an expectation of 208 subjects completing the study while demonstrating correct ELLIPTA inhaler use at visit 2.

ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Correct use and ease-of-use of placebo ELLIPTA dry-powder inhaler in adult patients with chronic obstructive pulmonary disease.
   Siler TM, Jain R, Collison K, Sharma R, et al · · 2022 · cited 2× · PMID 35969632 · DOI 10.1371/journal.pone.0273170
2. Correct use and ease of use of a placebo dry powder inhaler in subjects with asthma and chronic obstructive pulmonary disease.
   Feldman GJ, Galkin DV, Patel P, Collison KA, et al · · 2019 · cited 2× · PMID 30789018 · DOI 10.1177/1479973118815692