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Prevention of OM-85 on Bronchiectasis Exacerbation

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ClinicalTrials.gov Identifier: NCT01968421
Recruitment Status : Completed
First Posted : October 24, 2013
Results First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Collaborators:
Peking University
Capital Medical University
Tianjin Medical University
Zhejiang University
China Medical University, China
Tongji University
Wenzhou Medical University
Information provided by (Responsible Party):
Jinming Gao, Chinese Academy of Medical Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Bronchiectasis With Acute Exacerbation
Intervention Drug: OM-85 BV
Enrollment 196
Recruitment Details March 1, 2015 was the starting date
Pre-assignment Details  
Arm/Group Title OM-85 Placebo
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 99 [1] 97 [2]
Starting Trial [3] 99 97
Completed 99 [4] 97 [4]
Not Completed 0 0
[1]
March 1, 2015 was the date for recruiting patients
[2]
March 1, 2015 was the date for recruiting controls
[3]
starting to recuit first subject
[4]
Nov. 23, 2018 is the date for completing the trial
Arm/Group Title OM-85 Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 99 97 196
Hide Baseline Analysis Population Description
244 subjects were screened. 196 patients were enrolled.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 97 participants 196 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
75
  75.8%
70
  72.2%
145
  74.0%
>=65 years
24
  24.2%
27
  27.8%
51
  26.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 97 participants 196 participants
Female
53
  53.5%
57
  58.8%
110
  56.1%
Male
46
  46.5%
40
  41.2%
86
  43.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 97 participants 196 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
99
 100.0%
97
 100.0%
196
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 99 participants 97 participants 196 participants
99
 100.0%
97
 100.0%
196
 100.0%
[1]
Measure Description: All subjects included in this trial were Chinese.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 99 participants 97 participants 196 participants
99 97 196
1.Primary Outcome
Title Bronchiectasis Exacerbation
Hide Description the proportion of acute exacerbations
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OM-85 Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 99 97
Mean (Standard Deviation)
Unit of Measure: proportion of acute exacerbations
0.98  (1.19) 0.75  (0.98)
2.Secondary Outcome
Title Life Quality
Hide Description (1)St George' s Respiratory Questionnaire (SGRQ); (2)Leicester Cough Questionnaire (LCQ)
Time Frame 1 year
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Lung Function
Hide Description Lung function parameters: FEV1, FVC, FEV1/FVC;
Time Frame 1 year
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Rescue Medication
Hide Description Use of antibiotics and rapid-acting bronchodilator
Time Frame 1 year
Outcome Measure Data Not Reported
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OM-85 Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
OM-85 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/99 (0.00%)      0/97 (0.00%)    
Hide Serious Adverse Events
OM-85 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/99 (2.02%)      1/97 (1.03%)    
Respiratory, thoracic and mediastinal disorders     
Severe adverse events   2/99 (2.02%)  2 1/97 (1.03%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
OM-85 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/99 (4.04%)      7/97 (7.22%)    
Respiratory, thoracic and mediastinal disorders     
Common cold   4/99 (4.04%)  4 7/97 (7.22%)  7
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jinming Gao, Director of Clinical Trials
Organization: Peking Union Medical College Hospital
Phone: 8610691550549
EMail: gjinming@yahoo.com
Layout table for additonal information
Responsible Party: Jinming Gao, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01968421    
Other Study ID Numbers: Bronchiectasis-Gao001
Vifro pharmaceuticals ( Other Grant/Funding Number: PUMCHGao001 )
First Submitted: October 17, 2013
First Posted: October 24, 2013
Results First Submitted: July 23, 2019
Results First Posted: April 21, 2020
Last Update Posted: April 21, 2020