Adults 40 to 75, any sex, with COPD. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Change From Baseline in Peak FEV1 (Over 3 Hours) at Week 4Primary· Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).
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 l
Group
Value
95% CI
RPL554 0.75 mg
0.203
0.152 – 0.253
RPL554 1.5 mg
0.209
0.160 – 0.258
RPL554 3.0 mg
0.257
0.208 – 0.306
RPL554 6.0 mg
0.196
0.147 – 0.246
Placebo
0.057
0.007 – 0.106
Mean Change From Baseline FEV1 to Morning Trough FEV1 at Week 4Secondary· Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).
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.
Group
Value
95% CI
RPL554 0.75 mg
0.007
-0.038 – 0.053
RPL554 1.5 mg
-0.019
-0.063 – 0.025
RPL554 3.0 mg
0.040
-0.003 – 0.084
RPL554 6.0 mg
-0.026
-0.071 – 0.018
Placebo
-0.028
-0.072 – 0.016
Mean Change From Baseline FEV1 to Average FEV1 (Over 12 Hours) at Day 1 and Week 4Secondary· Baseline (pre-dose, Visit 2), up to 12 hours post-dose at Visit 2 (Day 1) and Visit 6 (Week 4).
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
Day 1
Group
Value
95% CI
RPL554 0.75 mg
0.088
0.058 – 0.117
RPL554 1.5 mg
0.077
0.048 – 0.107
RPL554 3.0 mg
0.103
0.074 – 0.132
RPL554 6.0 mg
0.095
0.065 – 0.125
Placebo
0.008
-0.022 – 0.038
Week 4
Group
Value
95% CI
RPL554 0.75 mg
0.039
-0.007 – 0.085
RPL554 1.5 mg
0.052
0.008 – 0.096
RPL554 3.0 mg
0.085
0.040 – 0.130
RPL554 6.0 mg
0.031
-0.014 – 0.076
Placebo
-0.033
-0.079 – 0.012
Mean Change From Baseline in COPD Symptoms Using the Exacerbations of Chronic Pulmonary Disease Tool Patient-Reported Outcome (EXACT-PRO) Scoring at Week 4Secondary· Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).
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
E-RS Total Score
Group
Value
95% CI
RPL554 0.75 mg
-1.07
-2.00 – -0.14
RPL554 1.5 mg
-1.26
-2.16 – -0.35
RPL554 3.0 mg
-0.80
-1.69 – 0.10
RPL554 6.0 mg
-0.92
-1.81 – -0.02
Placebo
1.19
0.30 – 2.08
E-RS Breathlessness Score
Group
Value
95% CI
RPL554 0.75 mg
-0.46
-0.92 – -0.01
RPL554 1.5 mg
-0.63
-1.07 – -0.18
RPL554 3.0 mg
-0.48
-0.92 – -0.04
RPL554 6.0 mg
-0.48
-0.92 – -0.04
Placebo
0.47
0.03 – 0.90
E-RS Cough/Sputum Score
Group
Value
95% CI
RPL554 0.75 mg
-0.22
-0.50 – 0.07
RPL554 1.5 mg
-0.30
-0.58 – -0.03
RPL554 3.0 mg
-0.14
-0.41 – 0.13
RPL554 6.0 mg
-0.21
-0.48 – 0.06
Placebo
0.36
0.09 – 0.63
E-RS Chest Symptoms Score
Group
Value
95% CI
RPL554 0.75 mg
-0.39
-0.70 – -0.08
RPL554 1.5 mg
-0.32
-0.62 – -0.02
RPL554 3.0 mg
-0.19
-0.48 – 0.11
RPL554 6.0 mg
-0.22
-0.52 – 0.07
Placebo
0.35
0.05 – 0.64
Mean Change From Baseline in Breathlessness as Assessed Using the St George's Respiratory Questionnaire (SGRQ) at Week 4Secondary· Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).
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
SGRQ-C Total score
Group
Value
95% CI
RPL554 0.75 mg
-2.56
-5.13 – 0.02
RPL554 1.5 mg
-3.18
-5.72 – -0.65
RPL554 3.0 mg
-2.63
-5.24 – -0.01
RPL554 6.0 mg
-3.01
-5.51 – -0.51
Placebo
-0.33
-2.90 – 2.23
SGRQ-C Symptoms score
Group
Value
95% CI
RPL554 0.75 mg
-4.73
-7.99 – -1.46
RPL554 1.5 mg
-1.89
-5.11 – 1.33
RPL554 3.0 mg
-2.17
-5.50 – 1.17
RPL554 6.0 mg
-4.33
-7.51 – -1.16
Placebo
1.25
-2.02 – 4.51
SGRQ-C Activity score
Group
Value
95% CI
RPL554 0.75 mg
-2.19
-5.30 – 0.91
RPL554 1.5 mg
-4.28
-7.34 – -1.23
RPL554 3.0 mg
-2.70
-5.85 – 0.46
RPL554 6.0 mg
-2.75
-5.76 – 0.27
Placebo
-2.16
-5.25 – 0.94
SGRQ-C Impact score
Group
Value
95% CI
RPL554 0.75 mg
-1.73
-4.91 – 1.46
RPL554 1.5 mg
-2.93
-6.06 – 0.20
RPL554 3.0 mg
-2.96
-6.20 – 0.28
RPL554 6.0 mg
-2.80
-5.89 – 0.29
Placebo
0.11
-3.07 – 3.28
Number of Patients With Treatment Emergent Adverse Events (TEAEs)Secondary· Up to end of study (approximately 6 weeks)
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.
Any TEAE
Group
Value
95% CI
RPL554 0.75 mg
27
RPL554 1.5 mg
36
RPL554 3.0 mg
29
RPL554 6.0 mg
29
Placebo
31
Any drug-related TEAE
Group
Value
95% CI
RPL554 0.75 mg
8
RPL554 1.5 mg
11
RPL554 3.0 mg
12
RPL554 6.0 mg
8
Placebo
10
Any severe TEAE
Group
Value
95% CI
RPL554 0.75 mg
4
RPL554 1.5 mg
1
RPL554 3.0 mg
2
RPL554 6.0 mg
1
Placebo
2
Any serious TEAE
Group
Value
95% CI
RPL554 0.75 mg
2
RPL554 1.5 mg
2
RPL554 3.0 mg
1
RPL554 6.0 mg
1
Placebo
1
Any serious drug-related TEAE
Group
Value
95% CI
RPL554 0.75 mg
1
RPL554 1.5 mg
1
RPL554 3.0 mg
0
RPL554 6.0 mg
0
Placebo
0
Any TEAE leading to drug interruption
Group
Value
95% CI
RPL554 0.75 mg
1
RPL554 1.5 mg
0
RPL554 3.0 mg
1
RPL554 6.0 mg
0
Placebo
0
Any TEAE leading to drug discontinuation
Group
Value
95% CI
RPL554 0.75 mg
6
RPL554 1.5 mg
1
RPL554 3.0 mg
4
RPL554 6.0 mg
2
Placebo
2
Any TEAE leading to death
Group
Value
95% CI
RPL554 0.75 mg
0
RPL554 1.5 mg
1
RPL554 3.0 mg
0
RPL554 6.0 mg
1
Placebo
0
Adverse events — posted to ClinicalTrials.gov
Time frame: 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)..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study investigates the effect of 4 weeks of twice daily treatment of four different doses of RPL554 (a phosphodiesterase \[PDE\]3/4 inhibitor) or placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Patients will be equally allocated to one of the five treatment options.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· recruiting
NCT07460154 — Structured Review: To Optimise Management and Prevent Harm in COPD
· NA
· recruiting
NCT07462221 — Effect of Telenursing on Oral Health
· NA
· recruiting
NCT07051707 — Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Verona Pharma plc
Last refreshed: 4 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03443414.