Trial Outcomes & Findings for Preference Attributes of ELLIPTA Dry Powder Inhaler (DPI) and HANDIHALER DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT02786927)

Results Overview

Preference between ELLIPTA inhaler and Handihaler based on the number of steps needed to take the medication was assessed by the inhaler preference questionnaire at Visit 3 or Early Withdrawal (EW) visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version. The analysis was performed on the Modified Intent-to-treat (ITT) Population comprised of all participants in the ITT Population (comprised all randomized participants who received 1 dose of at least 1 study inhaler) who completed at least one question from the 5 preference questions.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

214 participants

Primary outcome timeframe

Up to 18 days

Results posted on

2018-10-15

Participant Flow

Eligible participants who met the inclusion criteria at screening were randomized to use ELLIPTA inhaler and Handihaler inhaler in a crossover manner at Visit 1 and Visit 2 once daily for 5-9 days. At Visit 3, participants were asked to complete the inhaler preference questionnaire.

A total of 227 participants with diagnosis and documented history of chronic obstructive pulmonary disease (COPD) were screened for this open-label, cross-over study, of which 13 were screen failures, 2 were randomized by error and did not receive treatment and 212 participants entered the study treatment phase.

Participant milestones

Participant milestones
Measure	ELLIPTA and HandiHaler Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
Overall Study STARTED	212
Overall Study COMPLETED	207
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	ELLIPTA and HandiHaler Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
Overall Study Adverse Event	1
Overall Study Protocol Violation	4

Baseline Characteristics

Preference Attributes of ELLIPTA Dry Powder Inhaler (DPI) and HANDIHALER DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ELLIPTA and HandiHaler n=212 Participants Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
Age, Continuous	65.1 Years STANDARD_DEVIATION 9.15 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants
Sex: Female, Male Male	109 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · African American/African Heritage	22 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian or Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian - Japanese Heritage	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White - Arabic/North African Heritage	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White - White/Caucasian/European Heritage	187 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 18 days

Population: Modified ITT Population

Preference between ELLIPTA inhaler and Handihaler based on the number of steps needed to take the medication was assessed by the inhaler preference questionnaire at Visit 3 or Early Withdrawal (EW) visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version. The analysis was performed on the Modified Intent-to-treat (ITT) Population comprised of all participants in the ITT Population (comprised all randomized participants who received 1 dose of at least 1 study inhaler) who completed at least one question from the 5 preference questions.

Outcome measures

Outcome measures
Measure	ELLIPTA and HandiHaler n=208 Participants Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
Percentage of Participants Preferring the Inhaler Based on the Number of Steps Needed to Take the COPD Medication ELLIPTA inhaler	73 Percentage of participants
Percentage of Participants Preferring the Inhaler Based on the Number of Steps Needed to Take the COPD Medication HandiHaler	20 Percentage of participants
Percentage of Participants Preferring the Inhaler Based on the Number of Steps Needed to Take the COPD Medication No preference	7 Percentage of participants

SECONDARY outcome

Timeframe: Up to 18 days

Population: Modified ITT Population

Preference between ELLIPTA inhaler and Handihaler based on how easy it was to tell how many doses were left was assessed by the inhaler preference questionnaire at Visit 3 or EW visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version.

Outcome measures

Outcome measures
Measure	ELLIPTA and HandiHaler n=208 Participants Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
Percentage of Participants Preferring the Inhaler Based on How Easy it Was to Tell How Many Doses Were Left ELLIPTA inhaler	70 Percentage of participants
Percentage of Participants Preferring the Inhaler Based on How Easy it Was to Tell How Many Doses Were Left HandiHaler	18 Percentage of participants
Percentage of Participants Preferring the Inhaler Based on How Easy it Was to Tell How Many Doses Were Left No preference	12 Percentage of participants

SECONDARY outcome

Timeframe: Up to 18 days

Population: Modified ITT Population

Preference between ELLIPTA inhaler and HandiHaler based on the size of the inhaler was assessed by the inhaler preference questionnaire at Visit 3 or EW visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version.

Outcome measures

Outcome measures
Measure	ELLIPTA and HandiHaler n=208 Participants Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
Percentage of Participants Preferring the Inhaler Based on the Size of the Inhaler ELLIPTA inhaler	52 Percentage of participants
Percentage of Participants Preferring the Inhaler Based on the Size of the Inhaler HandiHaler	25 Percentage of participants
Percentage of Participants Preferring the Inhaler Based on the Size of the Inhaler No preference	24 Percentage of participants

Adverse Events

ELLIPTA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HandiHaler

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ELLIPTA n=208 participants at risk Participants received ELLIPTA inhaler at Visit 1/Visit 2 once daily for 5-9 days.	HandiHaler n=212 participants at risk Participants received HandiHaler inhaler at Visit 1/ Visit 2 once daily for 5-9 days.
Infections and infestations Sepsis	0.00% 0/208 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow-up contact. AEs and SAEs were collected in ITT Population which comprised of all participants who have been randomized and received one dose from at least one study inhaler.	0.47% 1/212 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow-up contact. AEs and SAEs were collected in ITT Population which comprised of all participants who have been randomized and received one dose from at least one study inhaler.
Infections and infestations Escherichia urinary tract infection	0.00% 0/208 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow-up contact. AEs and SAEs were collected in ITT Population which comprised of all participants who have been randomized and received one dose from at least one study inhaler.	0.47% 1/212 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow-up contact. AEs and SAEs were collected in ITT Population which comprised of all participants who have been randomized and received one dose from at least one study inhaler.
Renal and urinary disorders Acute kidney injury	0.00% 0/208 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow-up contact. AEs and SAEs were collected in ITT Population which comprised of all participants who have been randomized and received one dose from at least one study inhaler.	0.47% 1/212 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow-up contact. AEs and SAEs were collected in ITT Population which comprised of all participants who have been randomized and received one dose from at least one study inhaler.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/208 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow-up contact. AEs and SAEs were collected in ITT Population which comprised of all participants who have been randomized and received one dose from at least one study inhaler.	0.47% 1/212 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow-up contact. AEs and SAEs were collected in ITT Population which comprised of all participants who have been randomized and received one dose from at least one study inhaler.

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