Pulmonary Disease, Chronic Obstructive, COPDPhase 2NCT05270525
Effect of Ensifentrine (MK-5884/RPL554) on Sputum Markers of Inflammation in Chronic Obstructive Pulmonary Disease (COPD) (MK-5884-023/RPL554-CO-207)
A Phase 2 study testing Ensifentrine and LABA/LAMA in people with Pulmonary Disease, Chronic Obstructive, COPD, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 3 sites in United States.
Trial summary
Researchers are looking for new ways to treat chronic obstructive pulmonary disease (COPD). COPD is a long-lasting swelling of the airways that makes it hard to breathe. Researchers want to learn if a trial medicine called ensifentrine can help treat sputum caused by COPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, COPD
- What is being tested?
- Ensifentrine and LABA/LAMA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 May 2022to 1 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Participants with a history of cigarette smoking ≥10 pack years and an established clinical history of chronic obstructive pulmonary disease (COPD) as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD. Number of pack-years = [number of cigarettes per day/20] × number of years smoked [e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]
- COPD Severity: Pre- and Post-albuterol/salbutamol Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio of <0.70; Post-albuterol/salbutamol FEV1 ≥30 % and ≤80% of predicted normal calculated using the National Health and Nutrition Examination Survey III
- Regular use of bronchodilator COPD therapy, in any form (e.g., [Long-acting muscarinic antagonist] LAMA, [Long-acting β2-agonist] LABA, LAMA+LABA, LAMA+LABA+ [Inhaled corticosteroid(s)] ICS), for at least 4 weeks prior to Screening and agrees to use study supplied COPD Maintenance Therapy once daily through the final study visit
- Capable of using the jet nebulizer correctly and complying with all study restrictions and procedures
- Ability to perform acceptable spirometry in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
- Ability to produce sputum samples during the induced sputum procedure
Who cannot join
- Any clinically diagnosed lung disease other than COPD such as current asthma, diffuse interstitial lung diseases, cystic fibrosis, or clinically significant bronchiectasis as determined by the Investigator
- Hospitalizations for COPD exacerbation, pneumonia, or other respiratory infection in the 12 weeks prior to Screening.
- Alanine aminotransferase (ALT) ≥ 2 x upper limit of normal (ULN), alkaline phosphatase and/or bilirubin > 1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- Human immunodeficiency virus (HIV) infection or other immunodeficiency
- History of cancer within the last 5 years, except for well-treated basal cell carcinoma and squamous cell carcinoma of the skin
- Any clinically significant 12-lead electrocardiogram abnormalities at screening or baseline, including corrected QT interval by Fridericia's correction method >450 ms for males or >480 ms for females or history of significant cardiac dysrhythmia, including long QT syndrome
Show all 14Show fewer
- Known history of poor outcomes with sputum induction
- Known hypersensitivity to ensifentrine or other medications used in the study (e.g., albuterol or salmeterol)
- Not suitable for study supplied once daily COPD Maintenance Therapy per label warnings and contraindications
- Taking prohibited medication
- Prior receipt of Ohtuvayre or blinded nebulized study medication in an ensifentrine (RPL554) study. Note: Other ensifentrine formats (e.g., DPI, MPI) are not exclusionary
- Use of an experimental drug within 30 days or 5 half-lives of Screening, whichever is longer, and/or participation in a study treatment-free follow-up phase of a clinical trial within 30 days prior to Screening
- Use of an experimental medical device or participation in a follow-up phase of an experimental medical device clinical trial within 30 days prior to Screening
- Any other medical history, chronic uncontrolled diseases that the investigator considers clinically significant, examination or laboratory findings or reason that the Investigator considers makes the patient unsuitable to participate at Screening
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Alabama at Birmingham
Birmingham, Alabama, 35205
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Two-period Cross-over Study of the Effect of Ensifentrine on Sputum Markers of Inflammation in Subjects With COPD
Researchers are looking for new ways to treat chronic obstructive pulmonary disease (COPD). COPD is a long-lasting swelling of the airways that makes it hard to breathe. Researchers want to learn if a trial medicine called ensifentrine can help treat sputum caused by COPD. In this trial, researchers will compare a trial medicine called ensifentrine to a placebo. A placebo looks like the trial medicine but has no medicine in it. Using a placebo helps researchers better understand the effects of a trial medicine.
The goal of this trial is to learn about the effect of ensifentrine on a substance found in mucus (sputum) from the lungs that may be a sign of inflammation in participants with COPD.
- Being tested
- Ensifentrine, Placebo, LABA/LAMA
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnsifentrineDrug
Ensifentrine administered twice daily by oral inhalation via a standard jet nebulizer.
PlaceboDrug
Placebo matching ensifentrine administered twice daily by oral inhalation via a standard jet nebulizer.
LABA/LAMADrug
Also called Anoro®
Background treatment of LAMA/LABA administered per product approved label delivered by oral inhalation.
| Study group | Role | What they receive |
|---|---|---|
| Ensifentrine Sequence 1 | Experimental | In treatment period 1 participants will receive 3 mg ensifentrine twice daily administered via a standard jet nebulizer for 8 weeks followed by treatment period 2 during which participants will receive placebo matching ensifentrine twice daily administered via a standard jet nebulizer for 8 weeks. Throughout treatment sequence 1 participants will receive LABA/LAMA background therapy. Receives: Drug: Ensifentrine; Drug: Placebo; Drug: LABA/LAMA |
| Ensifentrine Sequence 2 | Experimental | In treatment period 1 participants will receive placebo matching ensifentrine twice daily administered via a standard jet nebulizer for 8 weeks followed by treatment period 2 during which participants will receive 3 mg ensifentrine twice daily administered via a standard jet nebulizer for 8 weeks. Throughout treatment sequence 2 participants will receive LABA/LAMA background therapy. Receives: Drug: Ensifentrine; Drug: Placebo; Drug: LABA/LAMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Absolute Change From Baseline in Sputum Neutrophil Cell Numbers
The Absolute change from baseline in sputum neutrophil cell numbers will be reported.
Measured: Baseline and 8 Weeks
Secondary outcomes (22)
Absolute Change in Cell Numbers From Baseline in Sputum Cell Counts
Absolute change in cell numbers from baseline in sputum cell counts (eosinophils, basophils, macrophages, lymphocytes, total cells) will be reported.
Measured: Baseline and 8 Weeks
Percent Change From Baseline in Sputum Cell Counts
Percent change from baseline in sputum cell counts (neutrophils, eosinophils, basophils, macrophages, lymphocytes, and total cells) will be reported.
Measured: Baseline and 8 Weeks
Percent Change From Baseline in Cytokines
Percent Change From Baseline in Cytokines will be reported.
Measured: Baseline and 8 Weeks
Percent Change From Baseline in Proteases
Percent Change From Baseline in Proteases will be reported.
Measured: Baseline and 8 Weeks
Percent Change From Baseline in Markers of Inflammation
Percent Change From Baseline in Markers of Inflammation will be reported.
Measured: Baseline and 8 Weeks
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 4 Weeks
Change from baseline in FEV1 at 4 weeks during the treatment period (predose and 2 hours postdose) will be reported.
Measured: Baseline and 4 Weeks
Change From Baseline in FEV1 at 8 Weeks
Change from baseline in FEV1 at 8 weeks during the treatment period (postdose) will be reported.
Measured: Baseline and 8 Weeks
Change From Baseline in Forced Vital Capacity (FVC) at 4 Weeks
Change from baseline in FVC at 4 weeks during the treatment period (predose and 2 hours postdose) will be reported.
Measured: Baseline and 4 Weeks
Change From Baseline in FVC at 8 Weeks
Change from baseline in FVC at 8 weeks during the treatment period (postdose) will be reported.
Measured: Baseline and 8 Weeks
Change From Baseline in Residual Volume (RV) at 4 Weeks
Change from baseline in RV at 4 weeks during the treatment period (predose and 2 hours postdose) will be reported.
Measured: Baseline and 4 Weeks
Change From Baseline in RV at 8 Weeks
Change from baseline in RV at 8 weeks (postdose) during the treatment period will be reported.
Measured: Baseline and 8 Weeks
Change From Baseline in Functional Residual Capacity (FRC) at 4 Weeks
Change from baseline in FRC at 4 weeks during the treatment period (predose and 2 hours postdose) will be reported.
Measured: Baseline and 4 Weeks
Change From Baseline in FRC at 8 Weeks
Change from baseline in FRC at 8 weeks (postdose) during the treatment period will be reported.
Measured: Baseline and 8 Weeks
Change From Baseline in Total Lung Capacity (TLC) at 4 Weeks
Change from baseline in TLC at 4 weeks during the treatment period (predose and 2 hours postdose) will be reported.
Measured: Baseline and 4 Weeks
Change From Baseline in TLC at 8 Weeks
Change from baseline in TLC at 8 weeks (postdose) during the treatment period will be reported.
Measured: Baseline and 8 Weeks
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Number of participants who experience one or more adverse events will be reported.
Measured: Up to approximately 8 Weeks
Change From Baseline in Systolic Blood Pressure
Change from baseline in systolic blood pressure will be reported.
Measured: Baseline and 8 Weeks
Change From Baseline in Diastolic Blood Pressure
Change from baseline in diastolic blood pressure will be reported.
Measured: Baseline and 8 Weeks
Change From Baseline in Heart Rate
Change from baseline in heart rate will be reported.
Measured: Baseline and 8 Weeks
Change From Baseline in QRS Duration
Change from baseline in QRS duration will be reported.
Measured: Baseline and 8 Weeks
Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Change from baseline in QTcF will be reported.
Measured: Baseline and 8 Weeks
Change From Baseline in QT Interval
Change from baseline for in QT interval will be reported.
Measured: Baseline and 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start27 May 2022
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic Obstructive, 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
- 70 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)
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270525
- Sponsor's protocol ID
- RPL554-CO-207
- Other IDs
- MK-5884-023, RPL554-CO-207
- Status last verified
- Oct 2026
- First submitted
- 8 Feb 2022
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Two-period Cross-over Study of the Effect of Ensifentrine on Sputum Markers of Inflammation in Subjects With COPD
- ClinicalTrials.gov ID
- NCT05270525
- Acronym / sponsor ID
- RPL554-CO-207
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USAIndustry (pharma, biotech, devices)
- Collaborators
- University of Alabama at Birmingham
- Study start
- 27 May 2022 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are looking for new ways to treat chronic obstructive pulmonary disease (COPD). COPD is a long-lasting swelling of the airways that makes it hard to breathe. Researchers want to learn if a trial medicine called ensifentrine can help treat sputum caused by COPD. In this trial, researchers will compare a trial medicine called ensifentrine to a placebo. A placebo looks like the trial medicine but has no medicine in it. Using a placebo helps researchers better understand the effects of a trial medicine.
The goal of this trial is to learn about the effect of ensifentrine on a substance found in mucus (sputum) from the lungs that may be a sign of inflammation in participants with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ensifentrine Sequence 1 | Experimental | Drug: Ensifentrine, Drug: Placebo, Drug: LABA/LAMAIn treatment period 1 participants will receive 3 mg ensifentrine twice daily administered via a standard jet nebulizer for 8 weeks followed by treatment period 2 during which participants will receive placebo matching ensifentrine twice daily administered via a standard jet nebulizer for 8 weeks. Throughout treatment sequence 1 participants will receive LABA/LAMA background therapy. |
| Ensifentrine Sequence 2 | Experimental | Drug: Ensifentrine, Drug: Placebo, Drug: LABA/LAMAIn treatment period 1 participants will receive placebo matching ensifentrine twice daily administered via a standard jet nebulizer for 8 weeks followed by treatment period 2 during which participants will receive 3 mg ensifentrine twice daily administered via a standard jet nebulizer for 8 weeks. Throughout treatment sequence 2 participants will receive LABA/LAMA background therapy. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants with a history of cigarette smoking ≥10 pack years and an established clinical history of chronic obstructive pulmonary disease (COPD) as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD. Number of pack-years = [number of cigarettes per day/20] × number of years smoked [e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]
- COPD Severity: Pre- and Post-albuterol/salbutamol Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio of <0.70; Post-albuterol/salbutamol FEV1 ≥30 % and ≤80% of predicted normal calculated using the National Health and Nutrition Examination Survey III
- Regular use of bronchodilator COPD therapy, in any form (e.g., [Long-acting muscarinic antagonist] LAMA, [Long-acting β2-agonist] LABA, LAMA+LABA, LAMA+LABA+ [Inhaled corticosteroid(s)] ICS), for at least 4 weeks prior to Screening and agrees to use study supplied COPD Maintenance Therapy once daily through the final study visit
- Capable of using the jet nebulizer correctly and complying with all study restrictions and procedures
- Ability to perform acceptable spirometry in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
Key exclusion criteria (14 listed)
- Any clinically diagnosed lung disease other than COPD such as current asthma, diffuse interstitial lung diseases, cystic fibrosis, or clinically significant bronchiectasis as determined by the Investigator
- Hospitalizations for COPD exacerbation, pneumonia, or other respiratory infection in the 12 weeks prior to Screening.
- Alanine aminotransferase (ALT) ≥ 2 x upper limit of normal (ULN), alkaline phosphatase and/or bilirubin > 1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- Human immunodeficiency virus (HIV) infection or other immunodeficiency
- History of cancer within the last 5 years, except for well-treated basal cell carcinoma and squamous cell carcinoma of the skin
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 |
|---|---|---|
| EnsifentrineEnsifentrine administered twice daily by oral inhalation via a standard jet nebulizer. | Drug | Ensifentrine Sequence 1, Ensifentrine Sequence 2 |
| PlaceboPlacebo matching ensifentrine administered twice daily by oral inhalation via a standard jet nebulizer. | Drug | Ensifentrine Sequence 1, Ensifentrine Sequence 2 |
| LABA/LAMAAlso: Anoro®Background treatment of LAMA/LABA administered per product approved label delivered by oral inhalation. | Drug | Ensifentrine Sequence 1, Ensifentrine Sequence 2 |
Primary outcome
The Absolute Change From Baseline in Sputum Neutrophil Cell Numbers
Time frame: Baseline and 8 Weeks
The Absolute change from baseline in sputum neutrophil cell numbers will be reported.
22 secondary outcomes
Absolute Change in Cell Numbers From Baseline in Sputum Cell Counts
Time frame: Baseline and 8 Weeks
Percent Change From Baseline in Sputum Cell Counts
Time frame: Baseline and 8 Weeks
Percent Change From Baseline in Cytokines
Time frame: Baseline and 8 Weeks
Percent Change From Baseline in Proteases
Time frame: Baseline and 8 Weeks
Percent Change From Baseline in Markers of Inflammation
Time frame: Baseline and 8 Weeks
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 4 Weeks
Time frame: Baseline and 4 Weeks
Change From Baseline in FEV1 at 8 Weeks
Time frame: Baseline and 8 Weeks
Change From Baseline in Forced Vital Capacity (FVC) at 4 Weeks
Time frame: Baseline and 4 Weeks
Change From Baseline in FVC at 8 Weeks
Time frame: Baseline and 8 Weeks
Change From Baseline in Residual Volume (RV) at 4 Weeks
Time frame: Baseline and 4 Weeks
Change From Baseline in RV at 8 Weeks
Time frame: Baseline and 8 Weeks
Change From Baseline in Functional Residual Capacity (FRC) at 4 Weeks
Time frame: Baseline and 4 Weeks
Change From Baseline in FRC at 8 Weeks
Time frame: Baseline and 8 Weeks
Change From Baseline in Total Lung Capacity (TLC) at 4 Weeks
Time frame: Baseline and 4 Weeks
Change From Baseline in TLC at 8 Weeks
Time frame: Baseline and 8 Weeks
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to approximately 8 Weeks
Change From Baseline in Systolic Blood Pressure
Time frame: Baseline and 8 Weeks
Change From Baseline in Diastolic Blood Pressure
Time frame: Baseline and 8 Weeks
Change From Baseline in Heart Rate
Time frame: Baseline and 8 Weeks
Change From Baseline in QRS Duration
Time frame: Baseline and 8 Weeks
Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Time frame: Baseline and 8 Weeks
Change From Baseline in QT Interval
Time frame: Baseline and 8 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Related trials for Pulmonary Disease, Chronic Obstructive, 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.
Medical Director study director
Merck Sharp & Dohme LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ensifentrine and LABA/LAMA in people with Pulmonary Disease, Chronic Obstructive, COPD, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 3 sites in United States.
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 6 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
The Absolute Change From Baseline in Sputum Neutrophil Cell Numbers (time frame: Baseline and 8 Weeks). 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 3 Nov 2026.