COPDPhase 2NCT03673670
Bronchodilator Effect of RPL554 Administered in Addition to Tiotropium/Olodaterol in Patients With COPD
A Phase 2 study testing RPL554 Suspension and Tiotropium/olodaterol (Respimat) in people with COPD, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 4 sites in 2 countries.
Trial summary
The study investigates the effect of 3 days of twice daily treatment of two different doses of RPL554 (a phosphodiesterase [PDE]3/4 inhibitor) or placebo, each administered in addition to once daily tiotropium/olodaterol (Respimat) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- RPL554 Suspension and Tiotropium/olodaterol (Respimat)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 16 Jul 2018to 13 Nov 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Male or female aged 40 and 80 years
- For males, not to donate sperm and either be sexually abstinent or use contraception as specified by the protocol. For females, be of non-childbearing potential or use a highly effective form of contraception
- 12-lead ECG with heart rate between 45 and 90 beats per minute, QTcF ≤450 msec for males, and ≤ 470 msec for females, QRS interval ≤120 msec and no clinically significant abnormality including morphology
- Screening Holter report with a minimum of 18 hours recording that is able to be evaluated for rhythm analysis showing no abnormality which indicates a significant impairment of patient safety or which may significantly impair interpretation
- Capable of complying with all study restrictions and procedures including ability to use the study nebulizer and Respimat® correctly.
Show all 15Show fewer
- Body mass index (BMI) between 18 and 36 kg/m2 and minimum weight of 45 kg.
- COPD diagnosis for at least 1 year and clinically stable COPD for 4 week
- Post-bronchodilator (two puffs of salbutamol/albuterol followed by two puffs of ipratropium) spirometry at Screening:
- Post-bronchodilator FEV1/forced vital capacity (FVC) ratio of ≤0.70
- Post-bronchodilator FEV1 ≥30 % and ≤70% of predicted normal
- Demonstrates ≥150 mL increase from pre-bronchodilator FEV1
- A chest X-ray showing no abnormalities, which are both clinically significant and unrelated to COPD.
- 12. Meet the concomitant medication restrictions and be expected to do so for the rest of the study.
- 13. Current and former smokers with smoking history of ≥10 pack years. 14. Capable of withdrawing from long acting bronchodilators for the duration of the study, and short acting bronchodilators for 8 hours prior to dosing.
Who cannot join
- A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation.
- COPD exacerbation requiring oral or parenteral steroids, or lower respiratory tract infection requiring antibiotics, in the last 3 months
- A history of one or more hospitalizations for COPD in the last 12 months
- Intolerance or hypersensitivity to tiotropium, olodaterol, atropine, ipratropium, or RPL554.
- Evidence of cor pulmonale or clinically significant pulmonary hypertension.
- Other respiratory disorders
Show all 22Show fewer
- Previous lung resection or lung reduction surgery.
- Use of oral COPD medications, except mucolytics, in the last 3 months
- Pulmonary rehabilitation, unless such treatment has been stable in the last 4 weeks
- History of, or reason to believe a patient has, drug or alcohol abuse within the past 5 years.
- Inability to perform acceptable spirometry or whole body plethysmography
- Received an experimental drug within 30 days or five half lives, whichever is longer.
- Patients with uncontrolled disease that the Investigator believes are clinically significant. This includes any hepatic disease, or an alanine aminotransferase or aspartate aminotransferase>2 x upper limit of normal (ULN).
- Documented cardiovascular disease: arrhythmias, angina, recent (<1 year) or suspected myocardial infarction, congestive heart failure, unstable or uncontrolled hypertension, or diagnosis of hypertension in the last 3 months
- Use of non-selective oral β-blockers.
- Major surgery (requiring general anesthesia) in the last 6 weeks or will not have fully recovered from surgery, or planned surgery through the end of the study.
- A disclosed history or one known to the Investigator, of significant non compliance in previous investigational studies or with prescribed medications.
- Required use of oxygen therapy, even on an occasional basis.
- Symptomatic prostatic hyperplasia or bladder-neck obstruction or with narrow-angle glaucoma.
- History of malignancy of any organ system within 5 years, with the exception of localized skin cancers (basal or squamous cell).
- Clinically significant abnormal values for safety laboratory tests (hematology, biochemistry, virology or urinalysis) as determined by the Investigator
- Any other reason that the Investigator considers makes the patient unsuitable to participate.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Allied Biomedical Research Holdings, d/b/a Vitalink Research
Greenville, South Carolina, 29615
Clinical Site Partners, LLC
Winter Park, Florida, 32789
United Kingdom2 sites
Respiratory Clinical Trials LTD,
London, W1G8HU
Medicines Evaluation Unit
Manchester, M23 9QZ
About this study
Official title: A Phase II, Randomized, Double Blind, Placebo Controlled, Three-way Crossover Study to Assess the Bronchodilator Effect of RPL554 Administered in Addition to Open Label Tiotropium/Olodaterol in Patients With COPD
The study investigates the effect of 3 days of twice daily treatment of two different doses of RPL554 (a phosphodiesterase [PDE]3/4 inhibitor) or placebo, each administered in addition to once daily tiotropium/olodaterol (Respimat) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Patients will receive each of the three treatment combinations in a randomized sequence using a crossover design
Read the detailed description
RPL554 is a dual inhibitor of phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) which are known to have a role in modulating the inflammatory airway response in respiratory diseases, including COPD. PDE3 inhibitors act as bronchodilators whilst PDE4 inhibitors have anti-inflammatory properties and there is also evidence to suggest that combined inhibition of PDE3 and PDE4 can have additive or synergistic anti-inflammatory and bronchodilator. The two doses of RPL554 (1.5 mg and 6 mg)have been selected based on the results from prior studies investigating single and multiple ascending doses in healthy subjects, single doses in asthmatics, single/multiple ascending doses in COPD patients, and 3 days of dosing in COPD patients. These doses were demonstrated to be both effective as a bronchodilator and well tolerated.
The purpose of the study is to investigate if RPL554 has an additive bronchodilator effect when administered in combination with a commonly used anticholinergic/β-agonist combination medication, tiotropium/olodaterol (Respimat), in this patient population measured by the peak forced expiratory volume in one second (FEV1), and forced vital capacity (FVC).
- Conditions
- COPD
- Being tested
- RPL554 Suspension, Placebo, Tiotropium/olodaterol (Respimat)
- Keywords
- COPD, Bronchodilation, FEV1
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPL554 SuspensionDrug
A PDE3/4 inhibitor
PlaceboDrug
A placebo solution
Tiotropium/olodaterol (Respimat)Drug
An anticholinergic/β-agonist combination medication
| Study group | Role | What they receive |
|---|---|---|
| 1.5 mg RPL554 and tiotropium/olodaterol | Experimental | 1.5 mg RPL554 suspension administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily Receives: Drug: RPL554 Suspension; Drug: Tiotropium/olodaterol (Respimat) |
| 6 mg RPL554 and tiotropium/olodaterol | Experimental | 6 mg RPL554 suspension administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily Receives: Drug: RPL554 Suspension; Drug: Tiotropium/olodaterol (Respimat) |
| Placebo and tiotropium/olodaterol | Experimental | Placebo administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily Receives: Drug: Placebo; Drug: Tiotropium/olodaterol (Respimat) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Peak FEV1 on Day 3
Change from baseline FEV1 to peak FEV1 (measured as the greatest value in the 4 hours post-dose after the morning dose) on Day 3
Measured: Change from pre-dose at 5, 15 and 30 minutes and 1, 1.5, 2 & 4 hours on Day 3
Secondary outcomes (13)
Change From Baseline to Trough FEV1 on Day 4
Change from baseline to morning trough FEV1 on Day 4
Measured: Change from pre-dose on Day 1 to pre-dose on Day 4
Change From Baseline in AUC0-4h FEV1 on Day 3
Change from baseline FEV1 to AUC FEV1 over 4 hours post-dose after the morning dose on Day 3. The endpoint is measured as AUC/interval length (average) and measured in liters. (Note: Endpoint is AUC/interval length (average) so the units are in liters.)
Measured: Change from pre-dose to each of the following timepoints: 5, 15 and 30 minutes and 1, 1.5, 2, 4 hours on Day 3 (after the morning dose)
Change From Baseline in AUC0-12h FEV1 on Day 3
Change from baseline in AUC over 12 hours post-dose after the morning dose on Day 3. The endpoint is measured as AUC/interval length (average) and measured in liters (Note: Endpoint is AUC/interval length (average) so the units are in liters.)
Measured: Change from pre-dose to each of the following timepoints: 5, 15 and 30 minutes and 1, 1.5, 2, 4, 6, 8, 12 hours on Day 3 (after the morning dose)
Change From Baseline in Peak FEV1 on Day 1
Change from baseline FEV1 to peak FEV1 in the 4 hours post-dose after the morning dose on Day 1
Measured: Change from pre-dose to each of the following timepoints: 5, 15 and 30 minutes and 1, 1.5, 2, 4 hours on Day 1 (after the morning dose), with the maximum change reported
Change From Baseline in Peak FEV1 After Evening Dose on Day 3
Change from baseline FEV1 to peak FEV1 in the 4 hours post-dose after the evening dose on Day 3
Measured: Change from pre-dose to each of the ollowing timepoints: 5, 15 and 30 minutes and 1, 1.5, 2, 4 hours on Day 3 (after the evening dose), with the maximum change reported
Change From Baseline in AUC0-12h FEV1 on Day 1
Change from baseline FEV1 to AUC FEV1 over 12 hours post-dose after the morning dose on Day 1. The endpoint is measured as AUC/interval length (average) and measured in liters (Note: Endpoint is AUC/interval length (average) so the units are in liters.)
Measured: Change from pre-dose to each of the following timepoints: 5, 15 and 30 minutes and 1, 1.5, 2, 4, 6, 8, 12 hours on Day 1 (after the morning dose)
Determination of Onset of Action on Day 1
Time to >10% increase in FEV1 from pre-first dose, censored at 2 hours
Measured: Change from pre-dose to the following timepoints: 5, 15 and 30 minutes and 1, 1.5, 2 hours on Day 1 (after the morning dose)
Residual Volume on Day 1
Change in residual volume during treatment
Measured: Change from pre-dose to 1.25 hours on Day 1 (after the morning dose)
Residual Volume on Day 3
Change in residual volume during treatment
Measured: Change from pre-dose on Day 1 to the following timepoints: pre-dose, 1.25, 8.25 and 12.25 hours on Day 3 (after the morning dose)
Functional Residual Capacity on Day 1
Change in functional residual capacity during treatment
Measured: Change from pre-dose to 1.25 hours on Day 1 (after the morning dose)
Functional Residual Capacity on Day 3
Change in functional residual capacity during treatment
Measured: Change from pre-dose on Day 1 to the following timepoints: pre-dose, 1.25, 8.25 and 12.25 hours on Day 3 (after the morning dose)
Specific Airway Conductance on Day 1
Change in specific airway conductance during treatment
Measured: Change from pre-dose to 1.25 hours on Day 1 (after the morning dose)
Specific Airway Conductance on Day 3
Change in specific airway conductance during treatment
Measured: Change from pre-dose on Day 1 to the following timepoints: pre-dose, 1.25, 8.25 and 12.25 hours on Day 3 (after the morning dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start16 Jul 2018
- Primary completion13 Nov 2018
- Study completion13 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Singh, Principal investigator, Medicines Evaluation Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673670
- Sponsor's protocol ID
- RPL554-CO-204
- Status last verified
- Sep 2019
- First submitted
- 7 Sep 2018
- Last updated
- 10 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double Blind, Placebo Controlled, Three-way Crossover Study to Assess the Bronchodilator Effect of RPL554 Administered in Addition to Open Label Tiotropium/Olodaterol in Patients With COPD
- ClinicalTrials.gov ID
- NCT03673670
- Acronym / sponsor ID
- RPL554-CO-204
- Conditions
- COPD
- Keywords
- COPD, Bronchodilation, FEV1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USAIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 13 Nov 2018 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Posted 10 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates the effect of 3 days of twice daily treatment of two different doses of RPL554 (a phosphodiesterase [PDE]3/4 inhibitor) or placebo, each administered in addition to once daily tiotropium/olodaterol (Respimat) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Patients will receive each of the three treatment combinations in a randomized sequence using a crossover design
Detailed description
RPL554 is a dual inhibitor of phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) which are known to have a role in modulating the inflammatory airway response in respiratory diseases, including COPD. PDE3 inhibitors act as bronchodilators whilst PDE4 inhibitors have anti-inflammatory properties and there is also evidence to suggest that combined inhibition of PDE3 and PDE4 can have additive or synergistic anti-inflammatory and bronchodilator. The two doses of RPL554 (1.5 mg and 6 mg)have been selected based on the results from prior studies investigating single and multiple ascending doses in healthy subjects, single doses in asthmatics, single/multiple ascending doses in COPD patients, and 3 days of dosing in COPD patients. These doses were demonstrated to be both effective as a bronchodilator and well tolerated.
The purpose of the study is to investigate if RPL554 has an additive bronchodilator effect when administered in combination with a commonly used anticholinergic/β-agonist combination medication, tiotropium/olodaterol (Respimat), in this patient population measured by the peak forced expiratory volume in one second (FEV1), and forced vital capacity (FVC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1.5 mg RPL554 and tiotropium/olodaterol | Experimental | Drug: RPL554 Suspension, Drug: Tiotropium/olodaterol (Respimat)1.5 mg RPL554 suspension administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily |
| 6 mg RPL554 and tiotropium/olodaterol | Experimental | Drug: RPL554 Suspension, Drug: Tiotropium/olodaterol (Respimat)6 mg RPL554 suspension administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily |
| Placebo and tiotropium/olodaterol | Experimental | Drug: Placebo, Drug: Tiotropium/olodaterol (Respimat)Placebo administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent
- Male or female aged 40 and 80 years
- For males, not to donate sperm and either be sexually abstinent or use contraception as specified by the protocol. For females, be of non-childbearing potential or use a highly effective form of contraception
- 12-lead ECG with heart rate between 45 and 90 beats per minute, QTcF ≤450 msec for males, and ≤ 470 msec for females, QRS interval ≤120 msec and no clinically significant abnormality including morphology
- Screening Holter report with a minimum of 18 hours recording that is able to be evaluated for rhythm analysis showing no abnormality which indicates a significant impairment of patient safety or which may significantly impair interpretation
Key exclusion criteria (22 listed)
- A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation.
- COPD exacerbation requiring oral or parenteral steroids, or lower respiratory tract infection requiring antibiotics, in the last 3 months
- A history of one or more hospitalizations for COPD in the last 12 months
- Intolerance or hypersensitivity to tiotropium, olodaterol, atropine, ipratropium, or RPL554.
- Evidence of cor pulmonale or clinically significant pulmonary hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPL554 SuspensionA PDE3/4 inhibitor | Drug | 1.5 mg RPL554 and tiotropium/olodaterol, 6 mg RPL554 and tiotropium/olodaterol |
| PlaceboA placebo solution | Drug | Placebo and tiotropium/olodaterol |
| Tiotropium/olodaterol (Respimat)An anticholinergic/β-agonist combination medication | Drug | 1.5 mg RPL554 and tiotropium/olodaterol, 6 mg RPL554 and tiotropium/olodaterol, Placebo and tiotropium/olodaterol |
Primary outcome
Change From Baseline in Peak FEV1 on Day 3
Time frame: Change from pre-dose at 5, 15 and 30 minutes and 1, 1.5, 2 & 4 hours on Day 3
Change from baseline FEV1 to peak FEV1 (measured as the greatest value in the 4 hours post-dose after the morning dose) on Day 3
13 secondary outcomes
Change From Baseline to Trough FEV1 on Day 4
Time frame: Change from pre-dose on Day 1 to pre-dose on Day 4
Change From Baseline in AUC0-4h FEV1 on Day 3
Time frame: Change from pre-dose to each of the following timepoints: 5, 15 and 30 minutes and 1, 1.5, 2, 4 hours on Day 3 (after the morning dose)
Change From Baseline in AUC0-12h FEV1 on Day 3
Time frame: Change from pre-dose to each of the following timepoints: 5, 15 and 30 minutes and 1, 1.5, 2, 4, 6, 8, 12 hours on Day 3 (after the morning dose)
Change From Baseline in Peak FEV1 on Day 1
Time frame: Change from pre-dose to each of the following timepoints: 5, 15 and 30 minutes and 1, 1.5, 2, 4 hours on Day 1 (after the morning dose), with the maximum change reported
Change From Baseline in Peak FEV1 After Evening Dose on Day 3
Time frame: Change from pre-dose to each of the ollowing timepoints: 5, 15 and 30 minutes and 1, 1.5, 2, 4 hours on Day 3 (after the evening dose), with the maximum change reported
Change From Baseline in AUC0-12h FEV1 on Day 1
Time frame: Change from pre-dose to each of the following timepoints: 5, 15 and 30 minutes and 1, 1.5, 2, 4, 6, 8, 12 hours on Day 1 (after the morning dose)
Determination of Onset of Action on Day 1
Time frame: Change from pre-dose to the following timepoints: 5, 15 and 30 minutes and 1, 1.5, 2 hours on Day 1 (after the morning dose)
Residual Volume on Day 1
Time frame: Change from pre-dose to 1.25 hours on Day 1 (after the morning dose)
Residual Volume on Day 3
Time frame: Change from pre-dose on Day 1 to the following timepoints: pre-dose, 1.25, 8.25 and 12.25 hours on Day 3 (after the morning dose)
Functional Residual Capacity on Day 1
Time frame: Change from pre-dose to 1.25 hours on Day 1 (after the morning dose)
Functional Residual Capacity on Day 3
Time frame: Change from pre-dose on Day 1 to the following timepoints: pre-dose, 1.25, 8.25 and 12.25 hours on Day 3 (after the morning dose)
Specific Airway Conductance on Day 1
Time frame: Change from pre-dose to 1.25 hours on Day 1 (after the morning dose)
Specific Airway Conductance on Day 3
Time frame: Change from pre-dose on Day 1 to the following timepoints: pre-dose, 1.25, 8.25 and 12.25 hours on Day 3 (after the morning dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dave Singh principal investigator
Medicines Evaluation Unit
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RPL554 Suspension and Tiotropium/olodaterol (Respimat) in people with COPD, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Peak FEV1 on Day 3 (time frame: Change from pre-dose at 5, 15 and 30 minutes and 1, 1.5, 2 & 4 hours on Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.