Trial Outcomes & Findings for DISKUS vs. ELLIPTA Device Preference Study in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01868009)

Last Updated: 2014-03-04

Results Overview

The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the numbers on the dose counter was summarized by study inhaler use sequence.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

287 participants

Primary outcome timeframe

up to Study Day 26

Results posted on

2014-03-04

Participant Flow

A total of 314 participants were screened; 287 participants were randomized, and 283 participants completed the study.

Eligible participants were randomized (1:1) to one of the two sequences of using the two placebo dry powder inhalers (ELLIPTA once a day then DISKUS twice a day or vise versa), each one taken separately for approximately 1 week. The first inhaler in the sequence was dispensed at Visit 1 and the second at Visit 2.

Participant milestones

Participant milestones
Measure	DISKUS BID in Period 1; ELLIPTA QD in Period 2 Participants who were on their current chronic obstructive pulmonary disease (COPD) medication(s) were randomized to receive DISKUS twice a day (BID) for 5-9 days in Period 1 and ELLIPTA once a day (QD) for 5-9 days in Period 2. There was no washout period between the two periods. Neither dry powder inhaler (DPI) contained any active treatment; placebo was administered in both DPIs.	ELLIPTA QD in Period 1; DISKUS BID in Period 2 Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
Period 1 (5-9 Days) STARTED	143	144
Period 1 (5-9 Days) COMPLETED	143	142
Period 1 (5-9 Days) NOT COMPLETED	0	2
Period 2 (5-9 Days) STARTED	143	142
Period 2 (5-9 Days) COMPLETED	141	142
Period 2 (5-9 Days) NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	DISKUS BID in Period 1; ELLIPTA QD in Period 2 Participants who were on their current chronic obstructive pulmonary disease (COPD) medication(s) were randomized to receive DISKUS twice a day (BID) for 5-9 days in Period 1 and ELLIPTA once a day (QD) for 5-9 days in Period 2. There was no washout period between the two periods. Neither dry powder inhaler (DPI) contained any active treatment; placebo was administered in both DPIs.	ELLIPTA QD in Period 1; DISKUS BID in Period 2 Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
Period 1 (5-9 Days) Adverse Event	0	2
Period 2 (5-9 Days) Adverse Event	1	0
Period 2 (5-9 Days) Protocol-defined Stopping Criteria	1	0

Baseline Characteristics

DISKUS vs. ELLIPTA Device Preference Study in Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DISKUS BID in Period 1 or 2; ELLIPTA QD in Period 1 or 2 n=287 Participants Participants who were on their current COPD medication(s) were randomized to receive one of the following two sequences of DPIs containing placebo: (1) DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2; (2) ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
Age, Continuous	64.7 Years STANDARD_DEVIATION 9.74 • n=5 Participants
Sex: Female, Male Female	134 Participants n=5 Participants
Sex: Female, Male Male	153 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	17 participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	270 participants n=5 Participants

PRIMARY outcome

Timeframe: up to Study Day 26

Population: Per Protocol (PP) Population: all participants in the Intent-to-Treat (ITT) Population (comprised of all participants who had been randomized and received one dose of at least one study inhaler) who completed at least one question from the seven preference questions

Outcome measures

Outcome measures
Measure	DISKUS BID in Period 1; ELLIPTA QD in Period 2 n=143 Participants Participants who were on their current COPD medication(s) were randomized to receive DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.	ELLIPTA QD in Period 1; DISKUS BID in Period 2 n=142 Participants Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
Number of Participants With the Indicated Device Preference Based on the Size of the Numbers on the Dose Counter ELLIPTA inhaler	107 participants	86 participants
Number of Participants With the Indicated Device Preference Based on the Size of the Numbers on the Dose Counter DISKUS inhaler	23 participants	34 participants
Number of Participants With the Indicated Device Preference Based on the Size of the Numbers on the Dose Counter No preference	13 participants	22 participants

SECONDARY outcome

Timeframe: up to Study Day 26

Population: PP Population

The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the number of steps needed to take the COPD medication was summarized by study inhaler use sequence.

Outcome measures

Outcome measures
Measure	DISKUS BID in Period 1; ELLIPTA QD in Period 2 n=143 Participants Participants who were on their current COPD medication(s) were randomized to receive DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.	ELLIPTA QD in Period 1; DISKUS BID in Period 2 n=142 Participants Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
Number of Participants With the Indicated Device Preference Based on the Number of Steps Needed to Take the COPD Medication ELLIPTA inhaler	100 Participants	90 Participants
Number of Participants With the Indicated Device Preference Based on the Number of Steps Needed to Take the COPD Medication DISKUS inhaler	29 Participants	36 Participants
Number of Participants With the Indicated Device Preference Based on the Number of Steps Needed to Take the COPD Medication No preference	14 Participants	16 Participants

SECONDARY outcome

Timeframe: up to Study Day 26

Population: PP Population. Only those participants responding to the question regarding the specified attribute were analyzed.

The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the device was summarized by study inhaler use sequence.

Outcome measures

Outcome measures
Measure	DISKUS BID in Period 1; ELLIPTA QD in Period 2 n=143 Participants Participants who were on their current COPD medication(s) were randomized to receive DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.	ELLIPTA QD in Period 1; DISKUS BID in Period 2 n=141 Participants Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
Number of Participants With the Indicated Device Preference Based on the Size of the Device ELLIPTA inhaler	75 Participants	70 Participants
Number of Participants With the Indicated Device Preference Based on the Size of the Device DISKUS inhaler	40 Participants	36 Participants
Number of Participants With the Indicated Device Preference Based on the Size of the Device No preference	28 Participants	35 Participants

Adverse Events

ELLIPTA QD in Period 1 or 2

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

DISKUS BID in Period 1 or 2

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ELLIPTA QD in Period 1 or 2 n=287 participants at risk Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in either Period 1 or Period 2. There was no washout period between the two periods. The DPI did not contain any active treatment; placebo was administered in the DPI.	DISKUS BID in Period 1 or 2 n=285 participants at risk Subjects will use the DISKUS inhaler twice daily for 5 to 9 days during the first period followed by the ELLIPTA inhaler once daily for 5 to 9 days during the second period.
Infections and infestations Bronchitis	0.35% 1/287 • On-treatment serious adverse events (SAEs) and non-serious AEs collected from the start of placebo until Visit 3 (end of study; up to Study Day 26) are reported. SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized and received one dose of at least one study inhaler.	0.00% 0/285 • On-treatment serious adverse events (SAEs) and non-serious AEs collected from the start of placebo until Visit 3 (end of study; up to Study Day 26) are reported. SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized and received one dose of at least one study inhaler.
Infections and infestations Oesophageal candidiasis	0.35% 1/287 • On-treatment serious adverse events (SAEs) and non-serious AEs collected from the start of placebo until Visit 3 (end of study; up to Study Day 26) are reported. SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized and received one dose of at least one study inhaler.	0.00% 0/285 • On-treatment serious adverse events (SAEs) and non-serious AEs collected from the start of placebo until Visit 3 (end of study; up to Study Day 26) are reported. SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized and received one dose of at least one study inhaler.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.35% 1/287 • On-treatment serious adverse events (SAEs) and non-serious AEs collected from the start of placebo until Visit 3 (end of study; up to Study Day 26) are reported. SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized and received one dose of at least one study inhaler.	0.00% 0/285 • On-treatment serious adverse events (SAEs) and non-serious AEs collected from the start of placebo until Visit 3 (end of study; up to Study Day 26) are reported. SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized and received one dose of at least one study inhaler.
Nervous system disorders Vertebrobasilar insufficiency	0.35% 1/287 • On-treatment serious adverse events (SAEs) and non-serious AEs collected from the start of placebo until Visit 3 (end of study; up to Study Day 26) are reported. SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized and received one dose of at least one study inhaler.	0.00% 0/285 • On-treatment serious adverse events (SAEs) and non-serious AEs collected from the start of placebo until Visit 3 (end of study; up to Study Day 26) are reported. SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized and received one dose of at least one study inhaler.
Vascular disorders Deep vein thrombosis	0.35% 1/287 • On-treatment serious adverse events (SAEs) and non-serious AEs collected from the start of placebo until Visit 3 (end of study; up to Study Day 26) are reported. SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized and received one dose of at least one study inhaler.	0.00% 0/285 • On-treatment serious adverse events (SAEs) and non-serious AEs collected from the start of placebo until Visit 3 (end of study; up to Study Day 26) are reported. SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized and received one dose of at least one study inhaler.

Other adverse events

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.
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