Trial Outcomes & Findings for Batefenterol/Fluticasone Furoate in Treatment of Chronic Obstructive Pulmonary Disease (NCT NCT02573870)

Last Updated: 2020-07-21

Results Overview

ECG measurements were taken in supine position after obtaining vital signs. Weighted mean was derived by calculating the area under the curve (AUC), and then dividing by the relevant time interval. Baseline was the pre-dose measurement on Day 1. Change from Baseline in 0 to 4 hours post-dose weighted mean heart rate was measured on Days 1, 28 and 42 and was analyzed using a mixed models repeated measures (MMRM) model. Intent-To-Treat (ITT) Population: all randomized participants who received at least one dose of study medication.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

Baseline and Day 42

Results posted on

2020-07-21

Participant Flow

This study consisted of 1-week run-in period, 6-week (42-day) treatment period and 1-week follow-up period. Eligible participants (par.) were randomized (2:1) to either batefenterol (BAT)/fluticasone furoate (FF) 300/100 micrograms (µg) or a placebo in double blinded treatment.

A total of 62 participants withn an established clinical history of chronic obstructive pulmonary disease (COPD) were randomized and received at least one dose of study drug (forming the Intent-to-Treat Population), out of which 7 participants were withdrawn from the study.

Participant milestones

Participant milestones
Measure	Placebo Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.	BAT/FF 300/100 µg Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed,while receiving investigational product.
Overall Study STARTED	20	42
Overall Study COMPLETED	20	35
Overall Study NOT COMPLETED	0	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.	BAT/FF 300/100 µg Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed,while receiving investigational product.
Overall Study Adverse Event	0	2
Overall Study Lack of Efficacy	0	1
Overall Study Other: Reached defined stopping criteria	0	1
Overall Study Lost to Follow-up	0	1
Overall Study Other: Fail to Meet Visit	0	2

Baseline Characteristics

Batefenterol/Fluticasone Furoate in Treatment of Chronic Obstructive Pulmonary Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=20 Participants Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.	BAT/FF 300/100 µg n=42 Participants Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.	Total n=62 Participants Total of all reporting groups
Age, Continuous	61.4 Years STANDARD_DEVIATION 8.86 • n=99 Participants	63.0 Years STANDARD_DEVIATION 7.88 • n=107 Participants	62.5 Years STANDARD_DEVIATION 8.17 • n=206 Participants
Sex: Female, Male Female	12 Participants n=99 Participants	24 Participants n=107 Participants	36 Participants n=206 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	18 Participants n=107 Participants	26 Participants n=206 Participants
Race/Ethnicity, Customized African American/African Heritage	3 Participants n=99 Participants	4 Participants n=107 Participants	7 Participants n=206 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	16 Participants n=99 Participants	36 Participants n=107 Participants	52 Participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline and Day 42

Population: ITT Population

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.	BAT/FF 300/100 µg n=42 Participants Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
Change From Baseline in 0 to 4 Hours Post-dose Weighted Mean Heart Rate at Day 42, Derived From Electrocardiograms (ECGs)	0.688 Beats per minute (bpm) Standard Error 1.5238	-1.557 Beats per minute (bpm) Standard Error 1.1374

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

BAT/FF 300/100 µg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=20 participants at risk Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.	BAT/FF 300/100 µg n=42 participants at risk Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
Ear and labyrinth disorders Vertigo	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.	0.00% 0/42 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
Gastrointestinal disorders Diarrhoea	0.00% 0/20 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.	7.1% 3/42 • Number of events 3 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
Gastrointestinal disorders Nausea	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.	0.00% 0/42 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
General disorders Fatigue	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.	0.00% 0/42 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
Infections and infestations Nasopharyngitis	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.	7.1% 3/42 • Number of events 3 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
Infections and infestations Sinusitis	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.	2.4% 1/42 • Number of events 1 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
Infections and infestations Candida infection	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.	0.00% 0/42 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
Investigations Blood pressure increased	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.	0.00% 0/42 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
Musculoskeletal and connective tissue disorders Back pain	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.	0.00% 0/42 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
Nervous system disorders Dysgeusia	0.00% 0/20 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.	9.5% 4/42 • Number of events 4 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/20 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.	4.8% 2/42 • Number of events 2 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.	0.00% 0/42 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.	0.00% 0/42 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
Respiratory, thoracic and mediastinal disorders Sinus congestion	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.	0.00% 0/42 • Serious Adverse Events (SAEs) were collected from start of the study until the follow-up contact (Visit 7 [Visit 6/EW +7 days]). Non-serious AEs were collected from the start of study treatment (Visit 2) until the follow-up contact (Visit 7) SAEs and non-serious AEs were reported for the ITT Population, comprised of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.

Additional Information

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