Trial Outcomes & Findings for Dose Ranging Study of RPL554 in Chronic Obstructive Pulmonary Disease (COPD) Patients (NCT NCT03443414)
NCT ID: NCT03443414
Last Updated: 2019-06-04
Results Overview
Spirometry assessments were used to assess pulmonary function including the forced expiratory volume in 1 second (FEV1). Peak FEV1 at Week 4 was defined as the maximum post-dose value among the 30 minutes, 1, 2 and 3 hour assessments collected at Visit 6. Baseline was defined as the FEV1 pre-dose assessment (-15 minutes) collected at Visit 2. A mixed model for repeated measures (MMRM) was used to model the change from baseline FEV1 using baseline FEV1 as a continuous fixed effect, randomized treatment, week and treatment-by-week as categorical fixed effect, and patient as random effect. The least squares (LS) mean change from baseline FEV1 to peak FEV1 (as measured over 3 hours) at Week 4 is presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
405 participants
Primary outcome timeframe
Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).
Results posted on
2019-06-04
Participant Flow
405 adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) were randomized into this double-blind, multicenter study, and 403 received study medication. Patients were recruited to 47 study centers in Bulgaria, Czech Republic, Germany, Poland, Romania and the United Kingdom.
Patients with a clinical diagnosis of COPD as defined by the American Thoracic Society/European Respiratory Society guidelines with symptoms compatible with COPD for at least 1 year prior to screening, and with clinically stable symptoms in the 4 weeks prior to screening and randomization were screened for inclusion.
Participant milestones
| Measure |
RPL554 0.75 mg
Patients were randomized to receive 0.75 milligrams (mg) RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 1.5 mg
Patients were randomized to receive 1.5 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 3.0 mg
Patients were randomized to receive 3.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 6.0 mg
Patients were randomized to receive 6.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
Placebo
Patients were randomized to receive placebo administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
82
|
81
|
82
|
80
|
80
|
|
Overall Study
Received Treatment
|
81
|
81
|
82
|
80
|
79
|
|
Overall Study
COMPLETED
|
71
|
78
|
76
|
75
|
75
|
|
Overall Study
NOT COMPLETED
|
11
|
3
|
6
|
5
|
5
|
Reasons for withdrawal
| Measure |
RPL554 0.75 mg
Patients were randomized to receive 0.75 milligrams (mg) RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 1.5 mg
Patients were randomized to receive 1.5 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 3.0 mg
Patients were randomized to receive 3.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 6.0 mg
Patients were randomized to receive 6.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
Placebo
Patients were randomized to receive placebo administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
0
|
4
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
2
|
2
|
1
|
|
Overall Study
Death
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Reason not specified
|
2
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Dose Ranging Study of RPL554 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Baseline characteristics by cohort
| Measure |
RPL554 0.75 mg
n=82 Participants
Patients were randomized to receive 0.75 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 1.5 mg
n=81 Participants
Patients were randomized to receive 1.5 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 3.0 mg
n=82 Participants
Patients were randomized to receive 3.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 6.0 mg
n=80 Participants
Patients were randomized to receive 6.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
Placebo
n=80 Participants
Patients were randomized to receive placebo administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
Total Title
n=405 Participants
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.6 Years
STANDARD_DEVIATION 7.05 • n=5 Participants
|
63.4 Years
STANDARD_DEVIATION 6.40 • n=7 Participants
|
62.5 Years
STANDARD_DEVIATION 6.51 • n=5 Participants
|
62.9 Years
STANDARD_DEVIATION 6.73 • n=4 Participants
|
63.5 Years
STANDARD_DEVIATION 6.44 • n=21 Participants
|
63.2 Years
STANDARD_DEVIATION 6.61 • n=8 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
160 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
245 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
405 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
405 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).Population: The full analysis set (FAS) consisted of all randomized patients, who received at least 1 dose of investigational product during the study and with at least 1 post-treatment efficacy data assessment. Data is presented for the number of patients with at least 1 on-treatment value who contributed to the model estimate.
Spirometry assessments were used to assess pulmonary function including the forced expiratory volume in 1 second (FEV1). Peak FEV1 at Week 4 was defined as the maximum post-dose value among the 30 minutes, 1, 2 and 3 hour assessments collected at Visit 6. Baseline was defined as the FEV1 pre-dose assessment (-15 minutes) collected at Visit 2. A mixed model for repeated measures (MMRM) was used to model the change from baseline FEV1 using baseline FEV1 as a continuous fixed effect, randomized treatment, week and treatment-by-week as categorical fixed effect, and patient as random effect. The least squares (LS) mean change from baseline FEV1 to peak FEV1 (as measured over 3 hours) at Week 4 is presented.
Outcome measures
| Measure |
RPL554 0.75 mg
n=81 Participants
Patients were randomized to receive 0.75 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 1.5 mg
n=81 Participants
Patients were randomized to receive 1.5 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 3.0 mg
n=82 Participants
Patients were randomized to receive 3.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 6.0 mg
n=80 Participants
Patients were randomized to receive 6.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
Placebo
n=79 Participants
Patients were randomized to receive placebo administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Peak FEV1 (Over 3 Hours) at Week 4
|
0.203 Liters
Interval 0.152 to 0.253
|
0.209 Liters
Interval 0.16 to 0.258
|
0.257 Liters
Interval 0.208 to 0.306
|
0.196 Liters
Interval 0.147 to 0.246
|
0.057 Liters
Interval 0.007 to 0.106
|
SECONDARY outcome
Timeframe: Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).Population: The FAS consisted of all randomized patients, who received at least 1 dose of investigational product during the study and with at least 1 post-treatment efficacy data assessment. Data is presented for the number of patients with at least 1 on-treatment value who contributed to the model estimate.
Morning trough FEV1 was defined as the last pre-dose value at Visit 6. Baseline was defined as the FEV1 pre-dose assessment (-15 minutes) collected at Visit 2. MMRM was used to model the change from baseline FEV1 using baseline FEV1 as a continuous fixed effect, randomized treatment, week and treatment-by-week as categorical fixed effect, and patient as random effect. The LS mean change from baseline FEV1 to morning trough FEV1 at Week 4 is presented.
Outcome measures
| Measure |
RPL554 0.75 mg
n=77 Participants
Patients were randomized to receive 0.75 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 1.5 mg
n=80 Participants
Patients were randomized to receive 1.5 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 3.0 mg
n=82 Participants
Patients were randomized to receive 3.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 6.0 mg
n=77 Participants
Patients were randomized to receive 6.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
Placebo
n=78 Participants
Patients were randomized to receive placebo administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline FEV1 to Morning Trough FEV1 at Week 4
|
0.007 Liters
Interval -0.038 to 0.053
|
-0.019 Liters
Interval -0.063 to 0.025
|
0.040 Liters
Interval -0.003 to 0.084
|
-0.026 Liters
Interval -0.071 to 0.018
|
-0.028 Liters
Interval -0.072 to 0.016
|
SECONDARY outcome
Timeframe: Baseline (pre-dose, Visit 2), up to 12 hours post-dose at Visit 2 (Day 1) and Visit 6 (Week 4).Population: The FAS consisted of all randomized patients, who received at least 1 dose of investigational product during the study and with at least 1 post-treatment efficacy data assessment. Data is presented for the number of patients with at least 1 on-treatment value who contributed to the model estimate.
Average FEV1 over 12 hours was defined as the area under the curve from 0 to 12 hours post-dose (AUC\[0-12\]) of the FEV1 values collected during the visit under analysis (Day 1 or Week 4), divided by the length of the time interval of interest (in hours). The AUC was calculated using the trapezoidal rule. Baseline was defined as the FEV1 pre-dose assessment (-15 minutes) collected at Visit 2. MMRM was used to model the change from baseline FEV1 using baseline FEV1 as a continuous fixed effect, randomized treatment, week and treatment-by-week as categorical fixed effect, and patient as random effect. The LS mean change from baseline FEV1 to average FEV1 over 12 hours at Day 1 and at Week 4 is presented.
Outcome measures
| Measure |
RPL554 0.75 mg
n=81 Participants
Patients were randomized to receive 0.75 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 1.5 mg
n=81 Participants
Patients were randomized to receive 1.5 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 3.0 mg
n=82 Participants
Patients were randomized to receive 3.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 6.0 mg
n=80 Participants
Patients were randomized to receive 6.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
Placebo
n=79 Participants
Patients were randomized to receive placebo administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline FEV1 to Average FEV1 (Over 12 Hours) at Day 1 and Week 4
Day 1
|
0.088 Liters
Interval 0.058 to 0.117
|
0.077 Liters
Interval 0.048 to 0.107
|
0.103 Liters
Interval 0.074 to 0.132
|
0.095 Liters
Interval 0.065 to 0.125
|
0.008 Liters
Interval -0.022 to 0.038
|
|
Mean Change From Baseline FEV1 to Average FEV1 (Over 12 Hours) at Day 1 and Week 4
Week 4
|
0.039 Liters
Interval -0.007 to 0.085
|
0.052 Liters
Interval 0.008 to 0.096
|
0.085 Liters
Interval 0.04 to 0.13
|
0.031 Liters
Interval -0.014 to 0.076
|
-0.033 Liters
Interval -0.079 to 0.012
|
SECONDARY outcome
Timeframe: Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).Population: The FAS consisted of all randomized patients, who received at least 1 dose of investigational product during the study and with at least 1 post-treatment efficacy data assessment. Data is presented for the number of patients with at least 1 on-treatment value who contributed to the model estimate.
Patients completed an electronic diary (e-diary) once daily which used the 14-item EXACT-PRO instrument to assess COPD symptoms. The EXACT-PRO instrument contains 11 respiratory symptom questions that comprise the derivative Evaluating Respiratory Symptoms (E-RS) instrument that was used to measure the effect of treatment with RPL554 on the severity of COPD symptoms overall. The E-RS tool contains 3 subscales to assess breathlessness, cough/sputum and chest symptoms. In addition to the subscale scores, a total score for the E-RS part was obtained. The raw totals for the E-RS score and for each of the subscales were converted to a scale range of 0 to 100 (least symptomatic to most symptomatic). MMRM was used to model the change from baseline using baseline as a continuous fixed effect, randomized treatment, week and treatment-by-week as categorical fixed effect, and patient as random effect. Baseline was the last non-missing assessment taken prior to investigational product start date.
Outcome measures
| Measure |
RPL554 0.75 mg
n=81 Participants
Patients were randomized to receive 0.75 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 1.5 mg
n=81 Participants
Patients were randomized to receive 1.5 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 3.0 mg
n=82 Participants
Patients were randomized to receive 3.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 6.0 mg
n=80 Participants
Patients were randomized to receive 6.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
Placebo
n=79 Participants
Patients were randomized to receive placebo administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in COPD Symptoms Using the Exacerbations of Chronic Pulmonary Disease Tool Patient-Reported Outcome (EXACT-PRO) Scoring at Week 4
E-RS Total Score
|
-1.07 Units on a scale
Interval -2.0 to -0.14
|
-1.26 Units on a scale
Interval -2.16 to -0.35
|
-0.80 Units on a scale
Interval -1.69 to 0.1
|
-0.92 Units on a scale
Interval -1.81 to -0.02
|
1.19 Units on a scale
Interval 0.3 to 2.08
|
|
Mean Change From Baseline in COPD Symptoms Using the Exacerbations of Chronic Pulmonary Disease Tool Patient-Reported Outcome (EXACT-PRO) Scoring at Week 4
E-RS Breathlessness Score
|
-0.46 Units on a scale
Interval -0.92 to -0.01
|
-0.63 Units on a scale
Interval -1.07 to -0.18
|
-0.48 Units on a scale
Interval -0.92 to -0.04
|
-0.48 Units on a scale
Interval -0.92 to -0.04
|
0.47 Units on a scale
Interval 0.03 to 0.9
|
|
Mean Change From Baseline in COPD Symptoms Using the Exacerbations of Chronic Pulmonary Disease Tool Patient-Reported Outcome (EXACT-PRO) Scoring at Week 4
E-RS Cough/Sputum Score
|
-0.22 Units on a scale
Interval -0.5 to 0.07
|
-0.30 Units on a scale
Interval -0.58 to -0.03
|
-0.14 Units on a scale
Interval -0.41 to 0.13
|
-0.21 Units on a scale
Interval -0.48 to 0.06
|
0.36 Units on a scale
Interval 0.09 to 0.63
|
|
Mean Change From Baseline in COPD Symptoms Using the Exacerbations of Chronic Pulmonary Disease Tool Patient-Reported Outcome (EXACT-PRO) Scoring at Week 4
E-RS Chest Symptoms Score
|
-0.39 Units on a scale
Interval -0.7 to -0.08
|
-0.32 Units on a scale
Interval -0.62 to -0.02
|
-0.19 Units on a scale
Interval -0.48 to 0.11
|
-0.22 Units on a scale
Interval -0.52 to 0.07
|
0.35 Units on a scale
Interval 0.05 to 0.64
|
SECONDARY outcome
Timeframe: Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).Population: The FAS consisted of all randomized patients, who received at least 1 dose of investigational product during the study and with at least 1 post-treatment efficacy data assessment. Data is presented for the numbers of patients with at least 1 on-treatment value who contributed to the model estimate.
Patients completed the COPD specific SGRQ (SGRQ-C) consisting of 14 items each weighted from 0 to a possible maximum of 100. Items 1-7 produced the symptoms score, 9-12 the activity score, and items 8, 10, 11, 13 and 14 the impacts score. Each component sub-score was calculated as a percentage of the summed weights of each item out of the sum of the maximum possible weight for that component (range 0-100). The total score was calculated by summing the weights to all positive responses in each component, where a positive item indicated the presence of symptoms, expressed as a percentage (range 0-100). Higher scores indicate a worse outcome. Baseline assessment was pre-dose at Visit 2. MMRM was used to model the change from baseline using baseline as a continuous fixed effect, randomized treatment, week and treatment-by-week as categorical fixed effect, patient as random effect. The LS mean change from baseline in the total, symptoms, activity and impact SGRQ-C scores are presented.
Outcome measures
| Measure |
RPL554 0.75 mg
n=81 Participants
Patients were randomized to receive 0.75 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 1.5 mg
n=81 Participants
Patients were randomized to receive 1.5 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 3.0 mg
n=82 Participants
Patients were randomized to receive 3.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 6.0 mg
n=80 Participants
Patients were randomized to receive 6.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
Placebo
n=79 Participants
Patients were randomized to receive placebo administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Breathlessness as Assessed Using the St George's Respiratory Questionnaire (SGRQ) at Week 4
SGRQ-C Total score
|
-2.56 Units on a scale
Interval -5.13 to 0.02
|
-3.18 Units on a scale
Interval -5.72 to -0.65
|
-2.63 Units on a scale
Interval -5.24 to -0.01
|
-3.01 Units on a scale
Interval -5.51 to -0.51
|
-0.33 Units on a scale
Interval -2.9 to 2.23
|
|
Mean Change From Baseline in Breathlessness as Assessed Using the St George's Respiratory Questionnaire (SGRQ) at Week 4
SGRQ-C Symptoms score
|
-4.73 Units on a scale
Interval -7.99 to -1.46
|
-1.89 Units on a scale
Interval -5.11 to 1.33
|
-2.17 Units on a scale
Interval -5.5 to 1.17
|
-4.33 Units on a scale
Interval -7.51 to -1.16
|
1.25 Units on a scale
Interval -2.02 to 4.51
|
|
Mean Change From Baseline in Breathlessness as Assessed Using the St George's Respiratory Questionnaire (SGRQ) at Week 4
SGRQ-C Activity score
|
-2.19 Units on a scale
Interval -5.3 to 0.91
|
-4.28 Units on a scale
Interval -7.34 to -1.23
|
-2.70 Units on a scale
Interval -5.85 to 0.46
|
-2.75 Units on a scale
Interval -5.76 to 0.27
|
-2.16 Units on a scale
Interval -5.25 to 0.94
|
|
Mean Change From Baseline in Breathlessness as Assessed Using the St George's Respiratory Questionnaire (SGRQ) at Week 4
SGRQ-C Impact score
|
-1.73 Units on a scale
Interval -4.91 to 1.46
|
-2.93 Units on a scale
Interval -6.06 to 0.2
|
-2.96 Units on a scale
Interval -6.2 to 0.28
|
-2.80 Units on a scale
Interval -5.89 to 0.29
|
0.11 Units on a scale
Interval -3.07 to 3.28
|
SECONDARY outcome
Timeframe: Up to end of study (approximately 6 weeks)Population: The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
The number of patients with TEAEs for each the following categories are presented: any TEAE, any drug-related TEAE, any severe TEAE, any serious TEAE, serious drug-related TEAE, any TEAE leading to drug interruption, any TEAE leading to drug discontinuation, and any TEAE leading to death. All AEs which started after the first dose of investigational product.or started prior to first dose and worsened, based on the Investigator assessment of severity, on or after first dose were considered to be treatment-emergent.
Outcome measures
| Measure |
RPL554 0.75 mg
n=81 Participants
Patients were randomized to receive 0.75 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 1.5 mg
n=81 Participants
Patients were randomized to receive 1.5 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 3.0 mg
n=82 Participants
Patients were randomized to receive 3.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 6.0 mg
n=80 Participants
Patients were randomized to receive 6.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
Placebo
n=79 Participants
Patients were randomized to receive placebo administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
|---|---|---|---|---|---|
|
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
Any TEAE
|
27 Patients
|
36 Patients
|
29 Patients
|
29 Patients
|
31 Patients
|
|
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
Any drug-related TEAE
|
8 Patients
|
11 Patients
|
12 Patients
|
8 Patients
|
10 Patients
|
|
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
Any severe TEAE
|
4 Patients
|
1 Patients
|
2 Patients
|
1 Patients
|
2 Patients
|
|
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
Any serious TEAE
|
2 Patients
|
2 Patients
|
1 Patients
|
1 Patients
|
1 Patients
|
|
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
Any serious drug-related TEAE
|
1 Patients
|
1 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
Any TEAE leading to drug interruption
|
1 Patients
|
0 Patients
|
1 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
Any TEAE leading to drug discontinuation
|
6 Patients
|
1 Patients
|
4 Patients
|
2 Patients
|
2 Patients
|
|
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
Any TEAE leading to death
|
0 Patients
|
1 Patients
|
0 Patients
|
1 Patients
|
0 Patients
|
Adverse Events
RPL554 0.75 mg
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
RPL554 1.5 mg
Serious events: 2 serious events
Other events: 25 other events
Deaths: 1 deaths
RPL554 3.0 mg
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
RPL554 6.0 mg
Serious events: 1 serious events
Other events: 19 other events
Deaths: 1 deaths
Placebo
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RPL554 0.75 mg
n=81 participants at risk
Patients were randomized to receive 0.75 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 1.5 mg
n=81 participants at risk
Patients were randomized to receive 1.5 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 3.0 mg
n=82 participants at risk
Patients were randomized to receive 3.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 6.0 mg
n=80 participants at risk
Patients were randomized to receive 6.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
Placebo
n=79 participants at risk
Patients were randomized to receive placebo administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
|---|---|---|---|---|---|
|
General disorders
Death
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/82 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/80 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/79 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/82 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/80 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.3%
1/79 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/81 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/82 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/80 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/79 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/82 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/80 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/79 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
1.2%
1/81 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/82 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/80 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/79 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
1.2%
1/81 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/82 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/80 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/79 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.2%
1/81 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/82 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/80 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/79 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/81 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/82 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/80 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/79 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
1/81 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/82 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/80 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/79 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
Other adverse events
| Measure |
RPL554 0.75 mg
n=81 participants at risk
Patients were randomized to receive 0.75 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 1.5 mg
n=81 participants at risk
Patients were randomized to receive 1.5 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 3.0 mg
n=82 participants at risk
Patients were randomized to receive 3.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
RPL554 6.0 mg
n=80 participants at risk
Patients were randomized to receive 6.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
Placebo
n=79 participants at risk
Patients were randomized to receive placebo administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.5%
2/81 • Number of events 2 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
4.9%
4/81 • Number of events 5 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
4.9%
4/82 • Number of events 4 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
6.2%
5/80 • Number of events 5 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
8.9%
7/79 • Number of events 7 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Infections and infestations
Rhinitis
|
1.2%
1/81 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/81 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/82 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/80 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
2.5%
2/79 • Number of events 2 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.9%
4/81 • Number of events 4 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
6.2%
5/81 • Number of events 5 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
3.7%
3/82 • Number of events 3 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
3.8%
3/80 • Number of events 3 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
7.6%
6/79 • Number of events 6 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.9%
4/81 • Number of events 4 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
4.9%
4/81 • Number of events 4 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
7.3%
6/82 • Number of events 6 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/80 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.3%
1/79 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.7%
3/81 • Number of events 3 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/81 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/82 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/80 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
6.3%
5/79 • Number of events 7 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
3.7%
3/81 • Number of events 5 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/82 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/80 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/79 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Nervous system disorders
Headache
|
4.9%
4/81 • Number of events 4 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
4.9%
4/81 • Number of events 4 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
8.5%
7/82 • Number of events 8 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
5.0%
4/80 • Number of events 5 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
3.8%
3/79 • Number of events 4 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
2.5%
2/81 • Number of events 2 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/82 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/80 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.3%
1/79 • Number of events 2 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Vascular disorders
Hypertension
|
2.5%
2/81 • Number of events 3 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/81 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
4.9%
4/82 • Number of events 4 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
3.8%
3/80 • Number of events 4 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.3%
1/79 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/81 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/82 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/80 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
2.5%
2/79 • Number of events 2 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Cardiac disorders
Ventricular extrasystoles
|
2.5%
2/81 • Number of events 2 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/81 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/82 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/80 • Number of events 2 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/79 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
2/81 • Number of events 2 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/81 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/82 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/80 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/79 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
2.4%
2/82 • Number of events 2 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/80 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/79 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
2.4%
2/82 • Number of events 2 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/80 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.3%
1/79 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
3/81 • Number of events 3 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
2.5%
2/81 • Number of events 2 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
2.4%
2/82 • Number of events 3 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/80 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
2.5%
2/79 • Number of events 2 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/82 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/80 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
2.5%
2/79 • Number of events 2 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
0.00%
0/81 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
2.4%
2/82 • Number of events 2 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.2%
1/80 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
1.3%
1/79 • Number of events 1 • TEAEs were collected from the first dose of investigational product up to 2 weeks after the end of the study (Visit 6) (approximately 6 weeks).
The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.
|
Additional Information
Brian Maurer, Senior Clinical Operations Director
Verona Pharma
Phone: (914) 767-5037
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator and Institution may only publish their center study activities and/or study data with prior written approval of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER