NCT02586506

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

Completed Phase 4 Results posted Last updated 11 October 2017

What this trial tests

Phase 4 trial testing Placebo ELLIPTA inhaler in Asthma in 259 participants. Completed in 4 February 2016.

Timeline

1 October 2015

Primary endpoint
4 February 2016

4 February 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	259
Start date	1 October 2015
Primary completion	4 February 2016
Estimated completion	4 February 2016
Sites	15 locations across United States

Drugs / interventions tested

• Placebo ELLIPTA inhaler — full drug profile →
• Questionnaire

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

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.

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. Primary · Day 28

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.

Group	Value	95% CI
Placebo ELLIPTA Inhaler	96	92 – 98

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 28

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 28

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.

Group	Value	95% CI
Placebo ELLIPTA Inhaler	98	95 – 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: 0/259 (0%)

Deaths: —

Other adverse events (1 terms — click to expand)

Reaction	System	Placebo ELLIPTA Inhaler
Headache	Nervous system disorders	—

Data from ClinicalTrials.gov NCT02586506 adverse events section.

Sponsor's own description

Asthma is a chronic disease of the lungs characterized by airway inflammation, bronchoconstriction and increased airway responsiveness. Inhaled corticosteroids (ICS), alone or in combination with inhaled long-acting beta-adrenergic agonists (LABA), are considered a mainstay of treatment for treatment. For inhaled medications, the choice of inhalation device is an important consideration because an inadequate technique reduces the delivery of medicines and effects of inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to the lungs effectively, is important. This study is designed to assess the correct use of the ELLIPTA inhaler in subjects with asthma and also 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 asthma and receiving asthma 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

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.