Pulmonary Disease, Chronic ObstructivePhase 2NCT04027439

Study Evaluating 5 Doses of RPL554 and Placebo in COPD Patients Via a Dry Powder Inhaler

A Phase 2 study testing Part A: RPL554 and Part B: RPL554 in people with Pulmonary Disease, Chronic Obstructive, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to investigate 5 doses of RPL554 and placebo, administered by dry powder inhaler (DPI), 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: Pulmonary Disease, Chronic Obstructive
What is being tested?: Part A: RPL554 and Part B: RPL554
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 37 participants
Where: 1 siteUnited States
Study dates: 10 Dec 2018to 23 May 2019
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

Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
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
Capable of complying with all study restrictions and procedures including ability to use the DPI correctly.
Body mass index (BMI) between 18 and 35 kg/m2 (inclusive) with a minimum weight of 45 kg.
COPD diagnosis for 1 year [prior to screening

Show all 15Show fewer

Ability to perform acceptable and reproducible spirometry.
Post-bronchodilator (four puffs of albuterol) spirometry at Screening demonstrating the following:
FEV1/Forced Vital Capacity (FVC) ratio of ≤0.70
FEV1 ≥40 % and ≤80% of predicted normal
≥150 mL increase from pre-bronchodilator FEV1
Clinically stable COPD in the 4 weeks prior to Screening and during the period between Screening and Part A.
A chest X-ray showing no abnormalities, which are both clinically significant and unrelated to COPD.
Meet the concomitant medication restrictions and be expected to do so for the rest of the study.
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, within 3 months of Screening or prior to Part A.
A history of one or more hospitalizations for COPD or pneumonia within 6 months of Screening or prior to Part A.
Intolerance or hypersensitivity to tiotropium, olodaterol, atropine, ipratropium, or RPL554.
Evidence of cor pulmonale or clinically significant pulmonary hypertension.
Other respiratory disorders

Show all 20Show fewer

Previous lung resection or lung reduction surgery.
Use of immunosuppressive therapy, including oral corticosteroids
Pulmonary rehabilitation, unless such treatment has been stable from 4 weeks prior to Screening and remains stable during the study.
History of, or reason to believe a patient has, drug or alcohol abuse within the past 5 years.
Received an experimental drug within 30 days or five half lives, whichever is longer.
Patients with uncontrolled disease including, but not limited to, endocrine, active hyperthyroidism, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, psychiatric, or ophthalmic diseases that the Investigator believes are clinically significant.
Documented cardiovascular disease, including any history of arrhythmias, angina, recent (<1 year) or suspected myocardial infarction, congestive heart failure, unstable or uncontrolled hypertension, or diagnosis of hypertension within 3 months prior to Screening
Use of non-selective oral β-blockers.
Major surgery (requiring general anesthesia) within 6 weeks prior to Screening, lack of full recovery from surgery at Screening, 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.
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, viral serology or urinalysis) at Screening, as determined by the Investigator. In particular, alanine aminotransferase or aspartate aminotransferase cannot be more than twice the upper limit of normal.
Any other reason that the Investigator considers makes the patient unsuitable to participate.

Trial locations and contacts

1 site in 1 country.

United States1 site

VitaLink Research -- Union
Union, South Carolina, 29379

Other trials in United States

About this study

Official title: A Phase II, Randomized Study to Assess the Pharmacokinetics, Safety and Pharmacodynamics of Single and Repeat Doses of RPL554 Administered by Dry Powdered Inhaler in Patients With COPD

The purpose of this study is to investigate 5 doses of RPL554 and placebo, administered by dry powder inhaler (DPI), in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Read the detailed description

The study will consist of two parts. Part A is a parallel group, placebo-controlled single dose study to ascertain the Pharmacokinetics (PK) profile, safety and bronchodilator effect of RPL554 administered via dry powder inhaler (DPI). Five of the 6 treatment arms will be double-blind and one will be single-blind (due to the different number of capsules administered). Part B is a placebo-controlled, complete block cross-over, repeat dose study to assess the bronchodilator effect of repeat doses of RPL554 delivered via a DPI.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Part A: RPL554, Part B: RPL554, Placebos
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.

Part A: RPL554Drug
1 dose of either 50mcg/100mcg/1500mcg/3000mcg/6000mcg or placebo via dry powder inhaler
Part B: RPL554Drug
Patients will receive 4 or 5 repeat dose treatments in crossover fashion - doses will be confirmed after Part A
PlacebosDrug
Part A: 1 dose of either 50ncg/100ncg/1500ncg/3000ncg/6000ncg or placebo via dry powder inhaler.
Part B: Patients will receive 4 or 5 repeat dose treatments in crossover fashion - doses will be confirmed after Part A.

Study groups in NCT04027439
Study group	Role	What they receive
Part A: RPL554	Active comparator	Placebo controlled, parallel group single dose. Five of the 6 treatment arms will be double-blind and one will be single-blind Receives: Drug: Part A: RPL554; Drug: Placebos
Part B: RPL554	Active comparator	Double-blind, placebo-controlled, complete block cross-over Receives: Drug: Part B: RPL554; Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

Part A: RPL554 Plasma Pharmacokinetic Parameter (AUC0-12)
RPL554 Plasma pharmacokinetics AUC0-12 (Area under the Curve) after single dose
Measured: Day 1
Part A: RPL554 Plasma Pharmacokinetic Parameter (AUC 0-t)
RPL554 Area under the curve at maximum concentration after a single dose
Measured: Day 1
Part A: RPL554 Plasma Pharmacokinetic Parameter (Half-life)
RPL554 Plasma pharmacokinetics Half-life concentration after a single dose
Measured: Day 1
Part B: Change From Baseline in Peak FEV1 (Over 4 Hours)
Change from Baseline FEV1 to Peak FEV1 (over 4 hours) on Day 7
Measured: Day 7

Secondary outcomes (29)

Part A: Change From Baseline in Average FEV1 (Over 4 Hours)
Change from Baseline FEV1 to Average FEV1 (over 4 hours) After Single Dose
Measured: Day 1
Part A: Change From Baseline in Average FEV1 (Over 12 Hours)
Change from Baseline FEV1 to Average FEV1 (over 12 hours) After Single Dose
Measured: Day 1
Part A: Change From Baseline in Peak FEV1 (Over 4 Hours)
Change from Baseline FEV1 to Peak FEV1 (over 4 hours) After Single Dose
Measured: Day 1
Part A: Safety and Tolerability / Hematology Safety Assessments
number of patients with treatment-emergent hematology abnormal laboratory assessments
Measured: Day 1
Part A: Safety and Tolerability / Blood Chemistry Safety Assessments
number of patients with treatment-emergent blood chemistry abnormal laboratory assessments
Measured: Day 1
Part A: Safety and Tolerability / Urinalysis Safety Assessments
number of patients with treatment-emergent urinalysis abnormal laboratory assessments
Measured: Day 1
Part A: Safety and Tolerability / Supine Vital Signs - Pulse Rate
Change from Baseline Pulse Rate to Peak Pulse Rate (over 4 hours) After Single Dose
Measured: Day 1
Part A: Safety and Tolerability / Supine Vital Signs - Blood Pressure
number of patients with treatment-emergent abnormal vital signs (blood pressure in mm Hg) (An increase from baseline of >=20 in systolic bp)
Measured: Day 1
Part A: Safety and Tolerability / ECG - QTcF
number of patients with treatment-emergent abnormal ECG parameters, QTcF in msec
Measured: Day 1
Part A: Safety and Tolerability / ECG - Heart Rate
number of patients with treatment-emergent clinically significant abnormal ECG parameters, heart rate in bpm
Measured: Day 1
Part B: Change From Baseline in Average FEV1 (Over 4 Hrs)
Change from baseline in average FEV1 (over 4 hours) on Day 7
Measured: Day 7
Part B: Change From Baseline in Average FEV1 (Over 12 Hours)
Change from baseline FEV1 in average FEV1 (over 12 hours) on Day 7
Measured: Day 7
Part B: Change From Baseline in Trough FEV1
Change from Baseline FEV1 to Morning Trough FEV1 on Day 7
Measured: Day 7
Part B: Change From Baseline in Peak FEV1 (Over 4 Hours)
Change from baseline FEV1 in peak FEV1 (over 4 hours) after first dose
Measured: Day 1
Part B: Change From Baseline in Average FEV1 (Over 4 Hours)
Change from baseline FEV1 in average FEV1 (over 4 hours) on Day 1
Measured: Day 1
Part B: Change From Baseline in Average FEV1 (Over 12 Hours)
Change from baseline FEV1 in average FEV1 (over 12 hours) on Day 1
Measured: Day 1
Part B: RPL554 Plasma Pharmacokinetic Parameter (Onset of Action)
Determination of onset of action (>10% increase in FEV1 from pre- to post-first dose, censored at 120 minutes) on Day 1
Measured: Day 1
Part B: Safety and Tolerability / Hematology Safety Assessments
number of patients with treatment-emergent hematology abnormal laboratory assessments (changes from normal at baseline to low or high on Day 7 or at the end of study in >3 patients in each treatment group).
Measured: Day 7
Part B: Safety and Tolerability / Blood Chemistry Safety Assessments
number of patients with treatment-emergent blood chemistry abnormal laboratory assessments (changes from normal at baseline to low or high on Day 7 in each treatment group).
Measured: Day 7
Part B: Safety and Tolerability / Urinalysis Safety Assessments
number of patients with treatment-emergent urinalysis abnormal laboratory assessments
Measured: Day 7
Part B: Safety and Tolerability / ECG - QTcF
number of patients with treatment-emergent clinically significant abnormal ECG parameters, QTcF in msec
Measured: Day 7
Part B: Safety and Tolerability / ECG - Heart Rate
number of patients with treatment-emergent abnormal ECG parameters, heart rate in bpm
Measured: Day 7
Part B: Safety and Tolerability / Supine Vital Signs - Pulse Rate
number of patients with treatment-emergent abnormal vital signs (pulse rate in bpm) An increase from baseline of >=20
Measured: Day 7
Part B: Safety and Tolerability / Supine Vital Signs - Blood Pressure
number of patients with treatment-emergent abnormal vital signs (systolic blood pressure in mm Hg) (An increase from baseline of >=20)
Measured: Day 7
Part B: Change From Baseline in Peak Pulse Rate (Day 1)
Change from baseline in peak pulse after first dose on Day 1
Measured: Day 1
Part B: Change From Baseline in Peak Pulse Rate (Day 7)
Change from baseline in peak pulse after morning dosing on Day 7
Measured: Day 7
Part B: RPL554 Plasma Pharmacokinetic Parameter (Tmax)
RPL554 steady-state PK (tmax) after morning dose on Day 7
Measured: Day 7
Part B: RPL554 Plasma Pharmacokinetic Parameter (Cmax)
RPL554 steady-state PK (Cmax and accumulation ratio) after morning dose on Day 7
Measured: Day 7
Part B: RPL554 Plasma Pharmacokinetic Parameter (AUC0-12h)
RPL554 steady-state PK (AUC0-12h and accumulation ratio) after morning dose on Day 7
Measured: Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Dec 201823 May 2019

First posted22 Jul 2019
Study start10 Dec 2018
Primary completion23 May 2019
Study completion23 May 2019

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 Pulmonary Disease, Chronic ObstructiveStudies 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: Factorial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04027439
Sponsor's protocol ID: RPL554-DP-201
Status last verified: Aug 2022
First submitted: 9 Mar 2019
Last updated: 26 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized Study to Assess the Pharmacokinetics, Safety and Pharmacodynamics of Single and Repeat Doses of RPL554 Administered by Dry Powdered Inhaler in Patients With COPD
ClinicalTrials.gov ID: NCT04027439
Acronym / sponsor ID: RPL554-DP-201
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USAIndustry (pharma, biotech, devices)
Collaborators: IQVIA Pty Ltd
Study start: 10 Dec 2018 (actual)
Primary completion: 23 May 2019 (actual)
Study completion: 23 May 2019 (actual)
First posted: 22 Jul 2019 (actual)
Results: Posted 7 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to investigate 5 doses of RPL554 and placebo, administered by dry powder inhaler (DPI), in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Part A: RPL554	Active comparator	Drug: Part A: RPL554, Drug: PlacebosPlacebo controlled, parallel group single dose. Five of the 6 treatment arms will be double-blind and one will be single-blind
Part B: RPL554	Active comparator	Drug: Part B: RPL554, Drug: PlacebosDouble-blind, placebo-controlled, complete block cross-over

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
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
Capable of complying with all study restrictions and procedures including ability to use the DPI correctly.
Body mass index (BMI) between 18 and 35 kg/m2 (inclusive) with a minimum weight of 45 kg.

Key exclusion criteria (20 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, within 3 months of Screening or prior to Part A.
A history of one or more hospitalizations for COPD or pneumonia within 6 months of Screening or prior to Part A.
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
Part A: RPL5541 dose of either 50mcg/100mcg/1500mcg/3000mcg/6000mcg or placebo via dry powder inhaler	Drug	Part A: RPL554
Part B: RPL554Patients will receive 4 or 5 repeat dose treatments in crossover fashion - doses will be confirmed after Part A	Drug	Part B: RPL554
PlacebosPart A: 1 dose of either 50ncg/100ncg/1500ncg/3000ncg/6000ncg or placebo via dry powder inhaler. Part B: Patients will receive 4 or 5 repeat dose treatments in crossover fashion - doses will be confirmed after Part A.	Drug	Part A: RPL554, Part B: RPL554

Primary outcome

Part A: RPL554 Plasma Pharmacokinetic Parameter (AUC0-12)
Time frame: Day 1
RPL554 Plasma pharmacokinetics AUC0-12 (Area under the Curve) after single dose
Part A: RPL554 Plasma Pharmacokinetic Parameter (AUC 0-t)
Time frame: Day 1
RPL554 Area under the curve at maximum concentration after a single dose
Part A: RPL554 Plasma Pharmacokinetic Parameter (Half-life)
Time frame: Day 1
RPL554 Plasma pharmacokinetics Half-life concentration after a single dose
Part B: Change From Baseline in Peak FEV1 (Over 4 Hours)
Time frame: Day 7
Change from Baseline FEV1 to Peak FEV1 (over 4 hours) on Day 7

29 secondary outcomes

Part A: Change From Baseline in Average FEV1 (Over 4 Hours)
Time frame: Day 1
Part A: Change From Baseline in Average FEV1 (Over 12 Hours)
Time frame: Day 1
Part A: Change From Baseline in Peak FEV1 (Over 4 Hours)
Time frame: Day 1
Part A: Safety and Tolerability / Hematology Safety Assessments
Time frame: Day 1
Part A: Safety and Tolerability / Blood Chemistry Safety Assessments
Time frame: Day 1
Part A: Safety and Tolerability / Urinalysis Safety Assessments
Time frame: Day 1
Part A: Safety and Tolerability / Supine Vital Signs - Pulse Rate
Time frame: Day 1
Part A: Safety and Tolerability / Supine Vital Signs - Blood Pressure
Time frame: Day 1
Part A: Safety and Tolerability / ECG - QTcF
Time frame: Day 1
Part A: Safety and Tolerability / ECG - Heart Rate
Time frame: Day 1
Part B: Change From Baseline in Average FEV1 (Over 4 Hrs)
Time frame: Day 7
Part B: Change From Baseline in Average FEV1 (Over 12 Hours)
Time frame: Day 7
Part B: Change From Baseline in Trough FEV1
Time frame: Day 7
Part B: Change From Baseline in Peak FEV1 (Over 4 Hours)
Time frame: Day 1
Part B: Change From Baseline in Average FEV1 (Over 4 Hours)
Time frame: Day 1
Part B: Change From Baseline in Average FEV1 (Over 12 Hours)
Time frame: Day 1
Part B: RPL554 Plasma Pharmacokinetic Parameter (Onset of Action)
Time frame: Day 1
Part B: Safety and Tolerability / Hematology Safety Assessments
Time frame: Day 7
Part B: Safety and Tolerability / Blood Chemistry Safety Assessments
Time frame: Day 7
Part B: Safety and Tolerability / Urinalysis Safety Assessments
Time frame: Day 7
Part B: Safety and Tolerability / ECG - QTcF
Time frame: Day 7
Part B: Safety and Tolerability / ECG - Heart Rate
Time frame: Day 7
Part B: Safety and Tolerability / Supine Vital Signs - Pulse Rate
Time frame: Day 7
Part B: Safety and Tolerability / Supine Vital Signs - Blood Pressure
Time frame: Day 7
Part B: Change From Baseline in Peak Pulse Rate (Day 1)
Time frame: Day 1
Part B: Change From Baseline in Peak Pulse Rate (Day 7)
Time frame: Day 7
Part B: RPL554 Plasma Pharmacokinetic Parameter (Tmax)
Time frame: Day 7
Part B: RPL554 Plasma Pharmacokinetic Parameter (Cmax)
Time frame: Day 7
Part B: RPL554 Plasma Pharmacokinetic Parameter (AUC0-12h)
Time frame: Day 7

Results and safety

Results posted to the registry on 7 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.15 mg/Part A	6	6
0.50 mg/Part A	6	6
1.5 mg/Part A	7	7
3 mg/Part A	6	6
6 mg/Part A	6	6
Placebo/Part A	6	6
Seq. 1/Part B	0	0
Seq. 2/Part B	0	0
Seq. 3/Part B	0	0
Seq. 4/Part B	0	0
Seq. 5/Part B	0	0
Seq. 6/Part B	0	0
Seq. 7/Part B	0	0
Seq. 8/Part B	0	0
Seq. 9/Part B	0	0
Seq. 10/Part B	0	0

Primary outcome: Part A: RPL554 Plasma Pharmacokinetic Parameter (AUC0-12)

Time frame: Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: h*pg/mL

Measure	0.15 mg n = 6	0.50 mg n = 6	1.5 mg n = 7	3 mg n = 6	6 mg n = 6
Value	260 (53.5)	472 (106.7)	2210 (62.3)	4160 (47.2)	9730 (62.3)

Population analysed: Pharmacokinetic (PK) Analysis Set in Part A: all randomized patients who had blood sampling performed after the single dose of RPL554 and had evaluable PK parameter data. The PK Analysis Set included the 31 patients who received RPL554 in Part A but not the 6 patients in the placebo group.

Primary outcome: Part A: RPL554 Plasma Pharmacokinetic Parameter (AUC 0-t)

Time frame: Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: h*pg/mL

Measure	0.15 mg n = 6	0.50 mg n = 6	1.5 mg n = 7	3 mg n = 6	6 mg n = 6
Value	222 (55.5)	495 (128.2)	2680 (56.5)	4920 (44.5)	11600 (68.3)

Primary outcome: Part A: RPL554 Plasma Pharmacokinetic Parameter (Half-life)

Time frame: Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: h

Measure	0.15 mg n = 1	0.50 mg n = 5	1.5 mg n = 7	3 mg n = 6	6 mg n = 6
Value	3.59	5.39 (28.7)	7.48 (43.3)	6.65 (33.6)	6.66 (25.4)

Primary outcome: Part B: Change From Baseline in Peak FEV1 (Over 4 Hours)

Time frame: Day 7. Mean (Standard Deviation). Unit: L

Measure	0.15 mg n = 34	0.50 mg n = 32	1.5 mg n = 31	3 mg n = 32	Placebo n = 32
Value	0.220 (0.1593)	0.293 (0.2411)	0.298 (0.2355)	0.378 (0.2182)	0.118 (0.1437)

3 mg vs Placebo: Contrast Ratio: 1.186 (95% CI 1.138 to 1.235), p <0.0001, ANCOVA
1.5 mg vs Placebo: Contrast Ratio: 1.134 (95% CI 1.088 to 1.181), p <0.0001, ANCOVA
0.50 mg vs Placebo: Contrast Ratio: 1.134 (95% CI 1.089 to 1.181), p <0.0001, ANCOVA

Population analysed: All efficacy analyses were carried out using the Full Analysis Set (FAS) in Part B: all randomized patients with sufficient data (pre-dose and at least 1 post-dose assessment of spirometry) collected after intake of study medication to compute the PD parameters (FEV1, FRC measurements) on at least 2 treatment periods in Part B. The FAS comprised: RPL554 0.15 mg (N=34); RPL554 0.5 mg (N=33); RPL554 1.5 mg (N=32); RPL554 3 mg (N=33); Placebo (N=32).

29 secondary outcomes are reported in the full results.

Adverse events

Time frame: Part A: 24 hours. Part B: Approximately 70 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: 0.15 mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part A: 0.50 mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part A: 1.5 mg	0 of 7 (0%)	1 of 7 (14.3%)	0 of 7
Part A: 3 mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part A: 6 mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part A: Placebo	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part B: 0.15 mg	0 of 35 (0%)	3 of 35 (8.6%)	0 of 35
Part B: 0.50 mg	0 of 33 (0%)	9 of 33 (27.3%)	0 of 33
Part B: 1.5 mg	0 of 32 (0%)	4 of 32 (12.5%)	0 of 32
Part B: 3 mg	0 of 33 (0%)	4 of 33 (12.1%)	0 of 33
Part B: Placebo	0 of 32 (0%)	5 of 32 (15.6%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

J Boscia, MD principal investigator

Vitalink Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 20 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 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 7 May 2021). 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?

Part A: RPL554 Plasma Pharmacokinetic Parameter (AUC0-12) (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04027439.

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 26 Sep 2022.