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Clinical Trial to Assess Pharmacodynamic Effects on Segmental Endotoxin Induced Inflammatory Response of BI 1026706 Versus Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02657408
Recruitment Status : Completed
First Posted : January 15, 2016
Results First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: BI 1026706
Drug: Placebo
Enrollment 57
Recruitment Details This was a randomised, placebo-controlled, double-blind, parallel-group study in a single trial center. In this study 57 healthy smoking subjects were entered and randomized. Subjects were allowed to rescreened twice based on investigator´s judgment with new informed consent & unique study subject number.
Pre-assignment Details All subjects (Subjs) were screened for eligibility to participate in trial. Subjs attended specialist site to ensure that they (the Subjs) met all implemented inclusion/exclusion criteria. Subjs were not to be randomised to trial drug if any of specific entry criteria was violated.
Arm/Group Title Placebo BI 1026706
Hide Arm/Group Description Subjects were orally treated with matching placebo as film-coated tablets twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28. Subjects were orally treated with BI 1026706 as film-coated tablets 100 mg twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Period Title: Overall Study
Started 28 29
Completed 25 22
Not Completed 3 7
Reason Not Completed
Adverse Event             3             7
Arm/Group Title Placebo BI 1026706 Total
Hide Arm/Group Description Subjects were orally treated with matching placebo as film-coated tablets twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28. Subjects were orally treated with BI 1026706 as film-coated tablets 100 mg twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28. Total of all reporting groups
Overall Number of Baseline Participants 28 29 57
Hide Baseline Analysis Population Description
Treated set: The treated set included all subjects who were randomized and treated with at least one dose of study drug.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 29 participants 57 participants
32.4  (8.4) 30.8  (5.4) 31.6  (7.0)
[1]
Measure Analysis Population Description: Treated Set
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 57 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
28
 100.0%
29
 100.0%
57
 100.0%
[1]
Measure Analysis Population Description: Treated set
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 57 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
28
 100.0%
29
 100.0%
57
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Treated set
Race (NIH/OMB)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 57 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
28
 100.0%
29
 100.0%
57
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: All subjects were white in this trial
[2]
Measure Analysis Population Description: Treated set
Total neutrophil count   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  cells*10^3/mL
Number Analyzed 24 participants 22 participants 46 participants
2.79  (2.46) 3.39  (4.13) 3.07  (3.34)
[1]
Measure Description: Total neutrophil count at baseline (Visit6)
[2]
Measure Analysis Population Description: Pharmacodynamic set (PDS): The pharmacodynamic set included all treated subjects who had evaluable cell counts for the primary or secondary endpoints 24 h after segmental LPS challenge.
1.Primary Outcome
Title Total Cell Count of Neutrophils in Bronchoalveolar Lavage (BAL) Fluid After 24 Hours of the Segmental Lipopolysaccharide (LPS) Challenge
Hide Description

Total cell count of neutrophils in Bronchoalveolar Lavage (BAL) fluid after 24 hours of the segmental Lipopolysaccharide (LPS) challenge.

The adjusted geometric means (gMeans) are obtained by exponentiating the Least Square (LS) means obtained by fitting an Analysis of variance (ANOVA) model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.

Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic set (PDS): The pharmacodynamic set included all treated subjects who had evaluable cell counts for the primary or secondary endpoints 24 h after segmental LPS challenge.
Arm/Group Title Placebo BI 1026706
Hide Arm/Group Description:
Subjects were orally treated with matching placebo as film-coated tablets twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Subjects were orally treated with BI 1026706 as film-coated tablets 100 mg twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Overall Number of Participants Analyzed 24 22
Geometric Mean (Standard Error)
Unit of Measure: cells*10^3/mililiter (mL)
687.02  (109.315) 872.61  (145.019)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BI 1026706
Comments The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.
Type of Statistical Test Equivalence
Comments confirmatory statistical hypothesis tested
Statistical Test of Hypothesis P-Value 0.3043
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 1.27
Confidence Interval (2-Sided) 90%
0.86 to 1.87
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Differential Cell Count of Neutrophils in BAL Fluid 24 h After Segmental LPS Challenge.
Hide Description

Differential cell count of neutrophils in BAL fluid 24 h after segmental LPS challenge.

The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.

Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
PDS
Arm/Group Title Placebo BI 1026706
Hide Arm/Group Description:
Subjects were orally treated with matching placebo as film-coated tablets twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Subjects were orally treated with BI 1026706 as film-coated tablets 100 mg twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Overall Number of Participants Analyzed 24 22
Geometric Mean (Standard Error)
Unit of Measure: Percentage of neutrophils
54.83  (3.094) 55.41  (3.266)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BI 1026706
Comments The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.
Type of Statistical Test Equivalence
Comments No statistical hypothesis tested
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 1.01
Confidence Interval (2-Sided) 90%
0.88 to 1.16
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Total Cell Count of Eosinophil in BAL Fluid After 24 Hours of the Segmental LPS Challenge
Hide Description

Total cell count of eosinophil in BAL fluid after 24 hours of the segmental LPS challenge.

The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.

Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
PDS
Arm/Group Title Placebo BI 1026706
Hide Arm/Group Description:
Subjects were orally treated with matching placebo as film-coated tablets twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Subjects were orally treated with BI 1026706 as film-coated tablets 100 mg twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Overall Number of Participants Analyzed 24 22
Geometric Mean (Standard Error)
Unit of Measure: cells*10^3/mL
6.95  (2.744) 10.72  (4.420)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BI 1026706
Comments The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.
Type of Statistical Test Equivalence
Comments No statistical hypothesis tested
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 1.54
Confidence Interval (2-Sided) 90%
0.59 to 4.03
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Differential Cell Count of Eosinophil in BAL Fluid 24 h After Segmental LPS Challenge.
Hide Description

Differential cell count of eosinophil in BAL fluid 24 h after segmental LPS challenge.

The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.

Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
PDS
Arm/Group Title Placebo BI 1026706
Hide Arm/Group Description:
Subjects were orally treated with matching placebo as film-coated tablets twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Subjects were orally treated with BI 1026706 as film-coated tablets 100 mg twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Overall Number of Participants Analyzed 24 22
Geometric Mean (Standard Error)
Unit of Measure: Percentage of eosinophil
0.55  (0.200) 0.65  (0.246)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BI 1026706
Comments The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.
Type of Statistical Test Equivalence
Comments No statistical hypothesis tested
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 1.17
Confidence Interval (2-Sided) 90%
0.49 to 2.85
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Total Cell Count of Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge
Hide Description

Total cell count of monocyte in BAL fluid after 24 hours of the segmental LPS challenge.

The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method. Monocyte cell count is the only cell count which was assessed by means of flow cytometry.

Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
PDS
Arm/Group Title Placebo BI 1026706
Hide Arm/Group Description:
Subjects were orally treated with matching placebo as film-coated tablets twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Subjects were orally treated with BI 1026706 as film-coated tablets 100 mg twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Overall Number of Participants Analyzed 24 22
Geometric Mean (Standard Error)
Unit of Measure: cells*10^3/mL
240.04  (34.306) 310.79  (46.393)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BI 1026706
Comments The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.
Type of Statistical Test Equivalence
Comments No statistical hypothesis tested
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 1.29
Confidence Interval (2-Sided) 90%
0.91 to 1.83
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Differential Cell Count of Monocyte in BAL Fluid 24 h After Segmental LPS Challenge.
Hide Description

Differential cell count of monocyte (determined by flow cytometry) in BAL fluid 24 h after segmental LPS challenge.

The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.

Monocyte cell count is the only cell count which was assessed by means of flow cytometry.

Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
PDS
Arm/Group Title Placebo BI 1026706
Hide Arm/Group Description:
Subjects were orally treated with matching placebo as film-coated tablets twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Subjects were orally treated with BI 1026706 as film-coated tablets 100 mg twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Overall Number of Participants Analyzed 24 22
Geometric Mean (Standard Error)
Unit of Measure: Percentage of monocyte
19.16  (1.058) 19.73  (1.138)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BI 1026706
Comments The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.
Type of Statistical Test Equivalence
Comments No statistical hypothesis tested
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 1.03
Confidence Interval (2-Sided) 90%
0.90 to 1.18
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Total Cell Count of Macrophage+Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge
Hide Description

Total cell count of macrophage+monocyte BAL fluid after 24 hours of the segmental LPS challenge.

The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.

Cytospin microscopy method cannot clearly differentiate between macrophages and monocytes, the total and differential cell count of macrophages and monocytes are presented together.

Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
PDS
Arm/Group Title Placebo BI 1026706
Hide Arm/Group Description:
Subjects were orally treated with matching placebo as film-coated tablets twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Subjects were orally treated with BI 1026706 as film-coated tablets 100 mg twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Overall Number of Participants Analyzed 24 22
Geometric Mean (Standard Error)
Unit of Measure: cells*10^3/mL
488.95  (52.417) 575.43  (64.431)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BI 1026706
Comments The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.
Type of Statistical Test Equivalence
Comments No statistical hypothesis tested
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 1.18
Confidence Interval (2-Sided) 90%
0.91 to 1.53
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Differential Cell Count of Macrophage+Monocyte in BAL Fluid 24 h After Segmental LPS Challenge.
Hide Description

Differential cell count of macrophage+monocyte in BAL fluid 24 h after segmental LPS challenge.

The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.

Cytospin microscopy method cannot clearly differentiate between macrophages and monocytes, the total and differential cell count of macrophages and monocytes are presented together.

Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
PDS
Arm/Group Title Placebo BI 1026706
Hide Arm/Group Description:
Subjects were orally treated with matching placebo as film-coated tablets twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Subjects were orally treated with BI 1026706 as film-coated tablets 100 mg twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Overall Number of Participants Analyzed 24 22
Geometric Mean (Standard Error)
Unit of Measure: Percentage of macrophage+monocyte
39.03  (2.499) 36.54  (2.444)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BI 1026706
Comments The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.
Type of Statistical Test Equivalence
Comments No statistical hypothesis tested
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 0.94
Confidence Interval (2-Sided) 90%
0.80 to 1.09
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Total Cell Count of Lymphocyte in BAL After 24 Hours of the Segmental LPS Challenge
Hide Description

Total cell count of lymphocyte after 24 hours of the segmental LPS challenge.

The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.

Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
PDS
Arm/Group Title Placebo BI 1026706
Hide Arm/Group Description:
Subjects were orally treated with matching placebo as film-coated tablets twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Subjects were orally treated with BI 1026706 as film-coated tablets 100 mg twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Overall Number of Participants Analyzed 24 22
Geometric Mean (Standard Error)
Unit of Measure: cells*10^3/mL
20.99  (3.976) 16.91  (3.346)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BI 1026706
Comments The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.
Type of Statistical Test Equivalence
Comments No statistical hypothesis tested
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 0.81
Confidence Interval (2-Sided) 90%
0.51 to 1.28
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Differential Cell Count of Lymphocyte in BAL Fluid 24 h After Segmental LPS Challenge.
Hide Description

Differential cell count of lymphocyte in BAL fluid 24 h after segmental LPS challenge.

The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.

Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
PDS
Arm/Group Title Placebo BI 1026706
Hide Arm/Group Description:
Subjects were orally treated with matching placebo as film-coated tablets twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Subjects were orally treated with BI 1026706 as film-coated tablets 100 mg twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
Overall Number of Participants Analyzed 24 22
Geometric Mean (Standard Error)
Unit of Measure: Percentage of lymphocyte
1.67  (0.283) 1.07  (0.190)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BI 1026706
Comments The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.
Type of Statistical Test Equivalence
Comments No statistical hypothesis tested
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 0.64
Confidence Interval (2-Sided) 90%
0.43 to 0.97
Estimation Comments [Not Specified]
Time Frame From first dose administration of the study medication to 4 days after last drug administration; up to 35 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo BI 1026706
Hide Arm/Group Description Subjects were orally treated with matching placebo as film-coated tablets twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28. Subjects were orally treated with BI 1026706 as film-coated tablets 100 mg twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
All-Cause Mortality
Placebo BI 1026706
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/29 (0.00%) 
Hide Serious Adverse Events
Placebo BI 1026706
Affected / at Risk (%) Affected / at Risk (%)
Total   1/28 (3.57%)   1/29 (3.45%) 
Injury, poisoning and procedural complications     
Post procedural complication  1  1/28 (3.57%)  0/29 (0.00%) 
Nervous system disorders     
Presyncope  1  1/28 (3.57%)  0/29 (0.00%) 
Renal and urinary disorders     
Calculus urinary  1  0/28 (0.00%)  1/29 (3.45%) 
1
Term from vocabulary, 19.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo BI 1026706
Affected / at Risk (%) Affected / at Risk (%)
Total   21/28 (75.00%)   18/29 (62.07%) 
Gastrointestinal disorders     
Abdominal pain upper  1  2/28 (7.14%)  1/29 (3.45%) 
Diarrhoea  1  0/28 (0.00%)  2/29 (6.90%) 
Flatulence  1  1/28 (3.57%)  2/29 (6.90%) 
General disorders     
Pyrexia  1  0/28 (0.00%)  3/29 (10.34%) 
Infections and infestations     
Lower respiratory tract infection  1  3/28 (10.71%)  2/29 (6.90%) 
Respiratory tract infection  1  0/28 (0.00%)  2/29 (6.90%) 
Rhinitis  1  0/28 (0.00%)  2/29 (6.90%) 
Injury, poisoning and procedural complications     
Post procedural complication  1  5/28 (17.86%)  6/29 (20.69%) 
Procedural complication  1  3/28 (10.71%)  3/29 (10.34%) 
Procedural headache  1  2/28 (7.14%)  0/29 (0.00%) 
Procedural pain  1  3/28 (10.71%)  1/29 (3.45%) 
Metabolism and nutrition disorders     
Dehydration  1  2/28 (7.14%)  0/29 (0.00%) 
Nervous system disorders     
Headache  1  13/28 (46.43%)  4/29 (13.79%) 
Psychiatric disorders     
Agitation  1  2/28 (7.14%)  2/29 (6.90%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/28 (7.14%)  2/29 (6.90%) 
Pleural effusion  1  0/28 (0.00%)  2/29 (6.90%) 
Rhinorrhoea  1  3/28 (10.71%)  5/29 (17.24%) 
1
Term from vocabulary, 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02657408    
Other Study ID Numbers: 1320.17
2015-001789-25 ( EudraCT Number )
First Submitted: January 14, 2016
First Posted: January 15, 2016
Results First Submitted: December 17, 2018
Results First Posted: July 10, 2019
Last Update Posted: July 10, 2019