Trial Outcomes & Findings for Prevention of OM-85 on Bronchiectasis Exacerbation (NCT NCT01968421)
NCT ID: NCT01968421
Last Updated: 2020-04-21
Results Overview
the proportion of acute exacerbations
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
196 participants
Primary outcome timeframe
1 year
Results posted on
2020-04-21
Participant Flow
March 1, 2015 was the starting date
Participant milestones
| Measure |
OM-85
The subjects will be randomly received two courses of 7mg of OM-85 to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
|
Placebo
The subjects will be randomly received two courses of 7mg of matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
97
|
|
Overall Study
Starting Trial
|
99
|
97
|
|
Overall Study
COMPLETED
|
99
|
97
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of OM-85 on Bronchiectasis Exacerbation
Baseline characteristics by cohort
| Measure |
OM-85
n=99 Participants
The subjects will be randomly received two courses of 7mg of OM-85 to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
|
Placebo
n=97 Participants
The subjects will be randomly received two courses of 7mg of matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
|
Total
n=196 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity
|
99 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
99 participants
n=5 Participants
|
97 participants
n=7 Participants
|
196 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearthe proportion of acute exacerbations
Outcome measures
| Measure |
OM-85
n=99 Participants
The subjects will be randomly received two courses of 7mg of OM-85 to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
|
Placebo
n=97 Participants
The subjects will be randomly received two courses of 7mg of matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
|
|---|---|---|
|
Bronchiectasis Exacerbation
|
0.98 proportion of acute exacerbations
Standard Deviation 1.19
|
0.75 proportion of acute exacerbations
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: 1 year(1)St George' s Respiratory Questionnaire (SGRQ); (2)Leicester Cough Questionnaire (LCQ)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearLung function parameters: FEV1, FVC, FEV1/FVC;
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearUse of antibiotics and rapid-acting bronchodilator
Outcome measures
Outcome data not reported
Adverse Events
OM-85
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OM-85
n=99 participants at risk
The subjects will be randomly received two courses of 7mg of OM-85 to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
|
Placebo
n=97 participants at risk
The subjects will be randomly received two courses of 7mg of matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Severe adverse events
|
2.0%
2/99 • Number of events 2 • 1 year
|
1.0%
1/97 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
OM-85
n=99 participants at risk
The subjects will be randomly received two courses of 7mg of OM-85 to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
|
Placebo
n=97 participants at risk
The subjects will be randomly received two courses of 7mg of matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
OM-85: two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Common cold
|
4.0%
4/99 • Number of events 4 • 1 year
|
7.2%
7/97 • Number of events 7 • 1 year
|
Additional Information
Dr. Jinming Gao, Director of Clinical Trials
Peking Union Medical College Hospital
Phone: 8610691550549
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place