Trial Outcomes & Findings for Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP) (NCT NCT01594827)
NCT ID: NCT01594827
Last Updated: 2019-02-26
Results Overview
The hypothesis for our primary outcome is that the aggressive treatment arm will result in significantly greater eradication of persistent MRSA from the respiratory tract of CF adolescents and adults on day 58 (1 month after completion of therapy) compared to the placebo/standard treatment arm. Our primary outcome will be comparing the proportion of CF patients in the treatment arm who have a negative induced sputum MRSA culture at Day 58 to the proportion of patients in the placebo arm who have a negative induced sputum MRSA culture at Day 58.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Day 58 (Visit 5), approximately 1 month after completion of the MRSA treatment protocol
Results posted on
2019-02-26
Participant Flow
The Persistent MRSA Eradication Protocol (PMEP) was a double-blind, randomized, placebo-controlled study performed at two CF centers (Johns Hopkins Hospital, Baltimore, MD; and University Hospitals Rainbow Babies and Children's Hospital, Cleveland, Ohio.) The study was conducted from October 2012 through March 2017.
After qualifying for and enrolling in the study based on inclusion criteria, participants were required to again demonstrate MRSA positive respiratory culture at the run-in visit (day -14) in order to be randomized to treatment arms. 39 participants were assessed for eligibility but only 29 matched inclusion criteria and were randomized.
Participant milestones
| Measure |
Inhaled Vancomycin and Oral Antibiotics
In the experimental arm CF participants were randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol.
|
Inhaled Placebo (Sterile Water) and Oral Antibiotics
In the active comparator arm CF participants were randomized to 28 days of inhaled sterile placebo (saline) and treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
|
Overall Study
COMPLETED
|
10
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Inhaled Vancomycin and Oral Antibiotics
In the experimental arm CF participants were randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol.
|
Inhaled Placebo (Sterile Water) and Oral Antibiotics
In the active comparator arm CF participants were randomized to 28 days of inhaled sterile placebo (saline) and treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients were followed for 3 months after completion of the treatment protocol.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Physician Decision
|
3
|
0
|
Baseline Characteristics
Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP)
Baseline characteristics by cohort
| Measure |
Inhaled Vancomycin and Oral Antibiotics
n=14 Participants
In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
Inhaled Placebo (Sterile Water) and Oral Antibiotics
n=15 Participants
In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.5 years
n=5 Participants
|
25.0 years
n=7 Participants
|
25.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 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
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
MRSA positive at baseline
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 58 (Visit 5), approximately 1 month after completion of the MRSA treatment protocolThe hypothesis for our primary outcome is that the aggressive treatment arm will result in significantly greater eradication of persistent MRSA from the respiratory tract of CF adolescents and adults on day 58 (1 month after completion of therapy) compared to the placebo/standard treatment arm. Our primary outcome will be comparing the proportion of CF patients in the treatment arm who have a negative induced sputum MRSA culture at Day 58 to the proportion of patients in the placebo arm who have a negative induced sputum MRSA culture at Day 58.
Outcome measures
| Measure |
Inhaled Vancomycin and Oral Antibiotics
n=10 Participants
In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
Inhaled Placebo (Sterile Water) and Oral Antibiotics
n=15 Participants
In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
|---|---|---|
|
Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 29Percentage of patients MRSA free by induced sputum respiratory tract culture one day after completion of four-week eradication protocol (Day 29) in intervention arm vs standard treatment arm
Outcome measures
| Measure |
Inhaled Vancomycin and Oral Antibiotics
n=10 Participants
In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
Inhaled Placebo (Sterile Water) and Oral Antibiotics
n=15 Participants
In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
|---|---|---|
|
Percentage of Patients MRSA Free by Induced Sputum Respiratory Tract Culture
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 58Change in Forced Expiratory Volume (FEV1)% predicted from baseline to day number 58
Outcome measures
| Measure |
Inhaled Vancomycin and Oral Antibiotics
n=10 Participants
In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
Inhaled Placebo (Sterile Water) and Oral Antibiotics
n=15 Participants
In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
|---|---|---|
|
Change in Forced Expiratory Volume (FEV1)% Predicted From Baseline to Day 58
|
-2.5 % predicted FEV1
Interval -6.0 to 1.0
|
1.0 % predicted FEV1
Interval -5.0 to 6.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 118Time to First CF Exacerbation using a standardized exacerbation definition from Day 1 to Day 118
Outcome measures
| Measure |
Inhaled Vancomycin and Oral Antibiotics
n=10 Participants
In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
Inhaled Placebo (Sterile Water) and Oral Antibiotics
n=15 Participants
In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
|---|---|---|
|
Time to First CF Exacerbation
|
NA Days
Standard Deviation NA
No exacerbations occurred in this group
|
68.4 Days
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: Days 58 and 118Total Number of Pulmonary Exacerbations using a standardized exacerbation definition at Days 58 and Days 118 in treatment vs. standard care group
Outcome measures
| Measure |
Inhaled Vancomycin and Oral Antibiotics
n=10 Participants
In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
Inhaled Placebo (Sterile Water) and Oral Antibiotics
n=15 Participants
In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
|---|---|---|
|
Total Number of Pulmonary Exacerbations
Day 58
|
0 Exacerbations
|
1 Exacerbations
|
|
Total Number of Pulmonary Exacerbations
Day 118
|
0 Exacerbations
|
3 Exacerbations
|
SECONDARY outcome
Timeframe: Days 29, 58, and 118Change in FEV1% predicted from Screening at Days 29, 58, and 118 in treatment vs. standard care group
Outcome measures
| Measure |
Inhaled Vancomycin and Oral Antibiotics
n=10 Participants
In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
Inhaled Placebo (Sterile Water) and Oral Antibiotics
n=15 Participants
In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
|---|---|---|
|
Change if FEV1% Predicted From Screening
Day 29
|
0.0 FEV1% predicted
Standard Error 2.1
|
1.1 FEV1% predicted
Standard Error 2.5
|
|
Change if FEV1% Predicted From Screening
Day 58
|
-3.0 FEV1% predicted
Standard Error 2.1
|
1.3 FEV1% predicted
Standard Error 2.5
|
|
Change if FEV1% Predicted From Screening
Day 118
|
-2.1 FEV1% predicted
Standard Error 1.4
|
-0.3 FEV1% predicted
Standard Error 2.2
|
SECONDARY outcome
Timeframe: Days 29 and 58Change in Patient Reported Quality of Life (CFQ-R)(respiratory) from baseline to Days 29 and 58. CFQ-R stands for Cystic Fibrosis Quality of Life Measure, Respiratory Domain. Overall range of absolute score 0 to +80. Higher score means better quality of life. Positive change in score means improvement in quality of life. Minimally clinically significant difference: +/- 4.0 units.
Outcome measures
| Measure |
Inhaled Vancomycin and Oral Antibiotics
n=10 Participants
In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
Inhaled Placebo (Sterile Water) and Oral Antibiotics
n=15 Participants
In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
|---|---|---|
|
Change in Patient Reported Quality of Life (CFQ-R)(Respiratory)
Day 29
|
3.3 units on a scale
Standard Error 4.1
|
11.5 units on a scale
Standard Error 4.2
|
|
Change in Patient Reported Quality of Life (CFQ-R)(Respiratory)
Day 58
|
-4.4 units on a scale
Standard Error 5.0
|
3.2 units on a scale
Standard Error 4.8
|
SECONDARY outcome
Timeframe: Day 58 (Visit 5)Population: No resistance to doxycycline or TMP/SMX. All developed resistance was to rifampin.
Number of patients with newly developed MRSA resistance to vancomycin, TMP/SMX, doxycycline, or rifampin.
Outcome measures
| Measure |
Inhaled Vancomycin and Oral Antibiotics
n=10 Participants
In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
Inhaled Placebo (Sterile Water) and Oral Antibiotics
n=15 Participants
In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
|---|---|---|
|
Development of Antibiotic Resistance
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Completion of Study Drug to Day 118Time between completion of Study Drug and need for anti-MRSA antibiotics to control or treat symptoms
Outcome measures
| Measure |
Inhaled Vancomycin and Oral Antibiotics
n=10 Participants
In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
Inhaled Placebo (Sterile Water) and Oral Antibiotics
n=15 Participants
In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
|---|---|---|
|
Time to First Anti-MRSA Antibiotics (After Treatment Period)
|
NA days
Standard Deviation NA
There were no exacerbations requiring treatment in this group
|
58 days
Standard Deviation 15
|
Adverse Events
Inhaled Vancomycin and Oral Antibiotics
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Inhaled Placebo (Sterile Water) and Oral Antibiotics
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Inhaled Vancomycin and Oral Antibiotics
n=14 participants at risk
In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
Inhaled Placebo (Sterile Water) and Oral Antibiotics
n=15 participants at risk
In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Exacerbation
|
0.00%
0/14 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
20.0%
3/15 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
|
Gastrointestinal disorders
Bowel Obstruction
|
7.1%
1/14 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
0.00%
0/15 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
Other adverse events
| Measure |
Inhaled Vancomycin and Oral Antibiotics
n=14 participants at risk
In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
Inhaled Placebo (Sterile Water) and Oral Antibiotics
n=15 participants at risk
In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
57.1%
8/14 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
20.0%
3/15 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
28.6%
4/14 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
40.0%
6/15 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
7/14 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
13.3%
2/15 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
|
Respiratory, thoracic and mediastinal disorders
Throat Symptoms
|
35.7%
5/14 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
20.0%
3/15 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
|
Respiratory, thoracic and mediastinal disorders
Chest Tightness
|
28.6%
4/14 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
26.7%
4/15 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
|
Nervous system disorders
Headache
|
21.4%
3/14 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
33.3%
5/15 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
|
Gastrointestinal disorders
Nausea
|
28.6%
4/14 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
13.3%
2/15 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
|
Gastrointestinal disorders
Heartburn
|
14.3%
2/14 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
26.7%
4/15 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
|
General disorders
Chest Pain
|
21.4%
3/14 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
13.3%
2/15 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
21.4%
3/14 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
6.7%
1/15 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
|
Respiratory, thoracic and mediastinal disorders
Drop in FEV1
|
21.4%
3/14 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
6.7%
1/15 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
|
Respiratory, thoracic and mediastinal disorders
Increase in Sputum Production
|
7.1%
1/14 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
20.0%
3/15 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
|
Respiratory, thoracic and mediastinal disorders
Chest Congestion
|
7.1%
1/14 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
20.0%
3/15 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Exacerbation
|
0.00%
0/14 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
20.0%
3/15 • Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Adverse events were collected at each study visit as per protocol
|
Additional Information
Dr. Mark Jennings
Johns Hopkins Unviversity School of Medicine
Phone: 410-502-7044
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place