Trial Outcomes & Findings for Preference on the Feedback Mechanisms of Dose Delivery Confirmation With the Breezhaler® Device Compared to the Ellipta® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT02551224)

Results Overview

This study will measure patient's perceptions of dose delivery, using a preference questionnaire on use of the Breezhaler® \& Ellipta® devices, in COPD patients naïve to DPI devices.The mean (SD) score on a scale of 1- 5 (1 = not at all confident/not at all; 5 = extremely confident/a very great deal) 1a. How confident were you that you received the full dose of medication from your inhaler? 1=Not At All Confident, 2=Not Very Confident, 3=Somewhat Confident, 4=Confident, 5=Extremely Confident 1b. How certain were you that there was no drug remaining in the device? 1=Not At All Certain,2=Not Very Certain, 3=Somewhat Certain,4=Certain, 5=Extremely Certain 1c. To what extent did the device help you to know that you have received all the medication? 1=Not At All, 2=A Little, 3=Somewhat, 4=Very Much, 5=A Very Great Deal

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

6 hours

Results posted on

2017-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	Breezhaler, Then Ellipta group1 Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by (minimum of 5 minutes) a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires are administered after using each device.	Ellipta Then, Breezhaler Group 2 Half of the patients will be assigned to first receive a single dose of placebo via the Ellipta® followed by (minimum of 5 minutes) a single dose of placebo via the Breezhaler® inhalation device. The evaluation questionnaires administered after using each device.
First Intervention STARTED	50	50
First Intervention COMPLETED	50	50
First Intervention NOT COMPLETED	0	0
Second Intervention (5 Min After First ) STARTED	50	50
Second Intervention (5 Min After First ) COMPLETED	50	50
Second Intervention (5 Min After First ) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preference on the Feedback Mechanisms of Dose Delivery Confirmation With the Breezhaler® Device Compared to the Ellipta® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=100 Participants Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by (minimum of 5 minutes) a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires were administered after using each device.
Age, Continuous	65.2 years STANDARD_DEVIATION 9.07 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 hours

Population: Full analysis set

This study will measure patient's perceptions of dose delivery, using a preference questionnaire on use of the Breezhaler® \& Ellipta® devices, in COPD patients naïve to DPI devices.The mean (SD) score on a scale of 1- 5 (1 = not at all confident/not at all; 5 = extremely confident/a very great deal) 1a. How confident were you that you received the full dose of medication from your inhaler? 1=Not At All Confident, 2=Not Very Confident, 3=Somewhat Confident, 4=Confident, 5=Extremely Confident 1b. How certain were you that there was no drug remaining in the device? 1=Not At All Certain,2=Not Very Certain, 3=Somewhat Certain,4=Certain, 5=Extremely Certain 1c. To what extent did the device help you to know that you have received all the medication? 1=Not At All, 2=A Little, 3=Somewhat, 4=Very Much, 5=A Very Great Deal

Outcome measures

Outcome measures
Measure	Breezhaler n=100 Participants Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by (minimum of 5 minutes) a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires were administered after using each device.	Ellipta n=100 Participants Half of the patients will be assigned to first receive a single dose of placebo via the Ellipta® followed by (minimum of 5 minutes) a single dose of placebo via the Breezhaler® inhalation device. The evaluation questionnaires were administered after using each device.
Patient's Preference on the Feedback Mechanisms of Dose Delivery Confirmation Using the Breezhaler® and Ellipta® Devices	4.3 units on a scale Standard Deviation 0.82	3.6 units on a scale Standard Deviation 1.05

SECONDARY outcome

Timeframe: 6 hours

Population: full analysis set

To measure in COPD patients naïve to DPIs, the comfort of the mouth pieces when performing a tight seal with the lips using the Breezhaler® and Ellipta® devices.The mean (SD) score on a scale of 1 - 5 (1 = not at all easy, 2= not very easy, 3=somewhat easy, 4=very easy, 5 = extremely easy)

Outcome measures

Outcome measures
Measure	Breezhaler n=100 Participants Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by (minimum of 5 minutes) a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires were administered after using each device.	Ellipta n=100 Participants Half of the patients will be assigned to first receive a single dose of placebo via the Ellipta® followed by (minimum of 5 minutes) a single dose of placebo via the Breezhaler® inhalation device. The evaluation questionnaires were administered after using each device.
Comfort of the Mouth Pieces for Performing a Tight Seal With the Lips.	4.3 units on a scale Standard Deviation 0.70	3.9 units on a scale Standard Deviation 0.84

Adverse Events

Breezhaler

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ellipta

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Breezhaler n=100 participants at risk Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by (minimum of 5 minutes) a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires were administered after using each device.	Ellipta n=100 participants at risk Half of the patients will be assigned to first receive a single dose of placebo via the Ellipta® followed by (minimum of 5 minutes) a single dose of placebo via the Breezhaler® inhalation device. The evaluation questionnaires were administered after using each device.
Infections and infestations rhinitis	1.0% 1/100 • Number of events 1 • 6 months	0.00% 0/100 • 6 months

Additional Information

Clinical Disclosure Office

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until publication of the pooled data (i.e.,data from all sites)in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER