Trial Outcomes & Findings for A Study to Evaluate the Anti-inflammatory Effects of Solithromycin in Chronic Obstructive Pulmonary Disease (NCT NCT02628769)

Results Overview

A number of sputum neutrophils per mL after treatment with solithromycin and placebo.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

28 days

Results posted on

2019-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	First Solithromycin, Then Placebo First 28-day treatment of 400 mg Solithromycin taken once a day, then 28-day treatment with placebo taken once per day.	First Placebo, Then Solithromycin First 28-day treatment with placebo taken once per day, then 28-day treatment of 400 mg Solithromycin taken once a day.
First Intervention STARTED	3	3
First Intervention COMPLETED	2	2
First Intervention NOT COMPLETED	1	1
Wash Out (28 Days) STARTED	2	2
Wash Out (28 Days) COMPLETED	2	2
Wash Out (28 Days) NOT COMPLETED	0	0
Second Intervention STARTED	2	2
Second Intervention COMPLETED	0	1
Second Intervention NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	First Solithromycin, Then Placebo First 28-day treatment of 400 mg Solithromycin taken once a day, then 28-day treatment with placebo taken once per day.	First Placebo, Then Solithromycin First 28-day treatment with placebo taken once per day, then 28-day treatment of 400 mg Solithromycin taken once a day.
First Intervention Adverse Event	1	0
First Intervention Withdrawal by Subject	0	1
Second Intervention Adverse Event	2	0
Second Intervention Physician Decision	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participant n=6 Participants All participants cross-over study
Age, Categorical <=18 years	0 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=6 Participants
Age, Categorical >=65 years	6 Participants n=6 Participants
Age, Continuous	69.3 years STANDARD_DEVIATION 3.6 • n=6 Participants
Sex: Female, Male Female	3 Participants n=6 Participants
Sex: Female, Male Male	3 Participants n=6 Participants
Region of Enrollment United Kingdom	6 participants n=6 Participants
BMI	26.7 kg/m^2 STANDARD_DEVIATION 3 • n=6 Participants
FEV1	1.29 litre STANDARD_DEVIATION 0.03 • n=6 Participants
COPD Assessment Test (CAT)	17 scores on a scale STANDARD_DEVIATION 7.3 • n=6 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Due to the early termination of the study, there were too few subjects and data collected to perform statistical analysis

A number of sputum neutrophils per mL after treatment with solithromycin and placebo.

Outcome measures

Outcome measures
Measure	Solithromycin n=3 Participants 28 day treatment of 400 mg Solithromycin taken once a day.	Placebo n=4 Participants 28 day treatment with placebo taken once per day.
Number of Sputum Neutrophils Per mL at 28 Days	2.47 10^6 cells/ml sputum Standard Error 0.76	5.30 10^6 cells/ml sputum Standard Error 1.21

SECONDARY outcome

Timeframe: 28 days

Population: Due to the early termination of the study, there were too few subjects and data collected to perform statistical analysis

Concentrations of sputum CXCL8 after treatment with solithromycin and placebo.

Outcome measures

Outcome measures
Measure	Solithromycin n=3 Participants 28 day treatment of 400 mg Solithromycin taken once a day.	Placebo n=4 Participants 28 day treatment with placebo taken once per day.
Concentrations of Sputum CXCL8 at 28 Days	2.99 ng/ml Standard Error 0.76	4.29 ng/ml Standard Error 0.43

SECONDARY outcome

Timeframe: 28 days

Population: No data collected for this Outcome due to early termination of the trial

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: No data collected for this Outcome due to early termination of the trial

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: No data collected for this Outcome due to early termination of the trial

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: No data collected for this Outcome due to early termination of the trial

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: No data collected for this Outcome due to early termination of the trial

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: Due to the early termination of the study, there were too few subjects and data collected to perform statistical analysis

Outcome measures

Outcome measures
Measure	Solithromycin n=3 Participants 28 day treatment of 400 mg Solithromycin taken once a day.	Placebo n=4 Participants 28 day treatment with placebo taken once per day.
Concentrations of CXCL8 in Nasal Lining Fluid With Solithromycin and Placebo at 28 Days	1.39 ng/ml Standard Error 0.58	5.14 ng/ml Standard Error 1.6

SECONDARY outcome

Timeframe: 28 days

Population: Due to the early termination of the study, there were too few subjects and data collected to perform statistical analysis

Outcome measures

Outcome measures
Measure	Solithromycin n=3 Participants 28 day treatment of 400 mg Solithromycin taken once a day.	Placebo n=4 Participants 28 day treatment with placebo taken once per day.
FEV1 After Treatment With Solithromycin and Placebo at 28 Days	1.13 litre Standard Error 0.16	1.05 litre Standard Error 0.08

SECONDARY outcome

Timeframe: 28 days

Population: Due to the early termination of the study, there were too few subjects and data collected to perform statistical analysis

R5-R20 assessed by impulse oscillometry after treatment with solithromycin and placebo.

Outcome measures

Outcome measures
Measure	Solithromycin n=3 Participants 28 day treatment of 400 mg Solithromycin taken once a day.	Placebo n=4 Participants 28 day treatment with placebo taken once per day.
R5-R20 After Treatment at 28 Days	0.31 kiloPascals per liter per second Standard Error 0.06	0.21 kiloPascals per liter per second Standard Error 0.05

SECONDARY outcome

Timeframe: 28 days

Population: Due to the early termination of the study, there were too few subjects and data collected to perform statistical analysis

COPD Assessment Test (CAT) scores after treatment with solithromycin and placebo. score of 0-40 to indicate the impact of the disease, the higher score better outcome

Outcome measures

Outcome measures
Measure	Solithromycin n=3 Participants 28 day treatment of 400 mg Solithromycin taken once a day.	Placebo n=4 Participants 28 day treatment with placebo taken once per day.
COPD Assessment Test (CAT) Scores	16 score on a scale Standard Error 4	15 score on a scale Standard Error 5

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	Solithromycin n=5 Participants 28 day treatment of 400 mg Solithromycin taken once a day.	Placebo n=5 Participants 28 day treatment with placebo taken once per day.
The Number of Adult COPD Patients With Treatment-related Adverse Events, as Assessed by CTCAE v4.0.	5 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

Population: No data collected for this Outcome due to early termination of the trial

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 84 days

Population: No data collected for this Outcome due to early termination of the trial

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

Population: No data collected for this Outcome due to early termination of the trial

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

Population: No data collected for this Outcome due to early termination of the trial

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

Population: No data collected for this Outcome due to early termination of the trial

Outcome measures

Outcome data not reported

Adverse Events

Solithromycin

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Solithromycin n=6 participants at risk 28 day treatment of 400 mg Solithromycin taken once a day.	Placebo n=6 participants at risk 28 day treatment with placebo taken once per day.
Hepatobiliary disorders Elevated liver tests	16.7% 1/6 • Number of events 1 • 28 days for each treatment period	0.00% 0/6 • 28 days for each treatment period

Other adverse events

Other adverse events
Measure	Solithromycin n=6 participants at risk 28 day treatment of 400 mg Solithromycin taken once a day.	Placebo n=6 participants at risk 28 day treatment with placebo taken once per day.
Gastrointestinal disorders Abdominal discomfort	33.3% 2/6 • Number of events 2 • 28 days for each treatment period	16.7% 1/6 • Number of events 1 • 28 days for each treatment period
Gastrointestinal disorders Nausea	0.00% 0/6 • 28 days for each treatment period	16.7% 1/6 • Number of events 1 • 28 days for each treatment period
Gastrointestinal disorders Flatulence	16.7% 1/6 • Number of events 1 • 28 days for each treatment period	0.00% 0/6 • 28 days for each treatment period
Gastrointestinal disorders Epigastric discomfort	16.7% 1/6 • Number of events 1 • 28 days for each treatment period	0.00% 0/6 • 28 days for each treatment period
Gastrointestinal disorders Gastro-oesophageal reflux	33.3% 2/6 • Number of events 2 • 28 days for each treatment period	0.00% 0/6 • 28 days for each treatment period
Hepatobiliary disorders Derranged LFTs	16.7% 1/6 • Number of events 1 • 28 days for each treatment period	0.00% 0/6 • 28 days for each treatment period
Skin and subcutaneous tissue disorders Puffy eyes	0.00% 0/6 • 28 days for each treatment period	16.7% 1/6 • Number of events 1 • 28 days for each treatment period

Additional Information

Louise Donnelly

Imperial College London

Phone: +44 02075947895

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place