Acute Exacerbation of Chronic Obstructive Pulmonary DiseasePhase 2NCT06175065
Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
A Phase 2 study testing RLS-0071 in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by ReAlta Life Sciences, Inc. at 4 sites in United States.
Trial summary
AECOPD is a major cause of hospital admission and mortality. They contribute to long-term decline in lung function, physical capacity, and quality of life (QoL). RLS-0071 is a novel peptide being developed for the treatment of AECOPD. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- What is being tested?
- RLS-0071
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Jan 2024to Jun 2025
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized participants with a prior diagnosis of COPD including spirometry within the prior year documenting a postbronchodilator FEV1/FVC ≤ 0.7 and an FEV1
- ≤ 80%, and a clinician identified admitting diagnosis of AECOPD: acute increase in dyspnea, sputum volume or purulence - without other attributable cause.
- Participants must have a moderate exacerbation of COPD according to the Rome guidelines
- ≥ 10 pack-years smoking history.
Who cannot join
- Endotracheal intubation or mechanical ventilation.
- Participants with severe exacerbation of COPD according to the Rome guidelines
- Participants with signs and symptoms consistent with an alternative diagnosis for worsening of pulmonary status
- Interstitial lung disease.
- Current or prior history of asthma.
- Known hypersensitivity, allergy, or reaction to polyethylene glycol (PEG)
Show all 18Show fewer
- Preexisting autoimmune disease: History of autoimmune disease and/or use of chronic steroids of >10mg/d (prednisone or equivalent) for more than 14 days prior to enrollment
- Current renal dialysis or renal dialysis planned or anticipated in the next 7 days.
- Has confounding medical conditions, including:
- diabetic coma,
- uncontrolled New York Heart Association Class IV congestive heart failure,
- uncontrolled angina,
- stroke or transient ischemic attack (TIA) within 4 weeks before study entry,
- clinically significant arrhythmias not controlled by medication, or
- idiopathic pulmonary fibrosis,
- Has a weight >120 kg at Screening.
- Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP.
- Has systemic immunosuppression/immune deficiency
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Site 03
Glen Burnie, Maryland, 21061
Site 04
Omaha, Nebraska, 68198
Site 01
Philadelphia, Pennsylvania, 19122
Site 02
St. Petersburg, Florida, 33701
About this study
Official title: A Phase 2a Randomized, Doubled-Blind, Placebo-Controlled Trial to Evaluate Safety, Pharmacokinetics and Pharmacokinetic-Pharmacodynamic Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
AECOPD is a major cause of hospital admission and mortality. They contribute to long-term decline in lung function, physical capacity, and quality of life (QoL). RLS-0071 is a novel peptide being developed for the treatment of AECOPD. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of adults with moderate exacerbations of COPD.
Read the detailed description
This is a randomized, double-blind, placebo controlled trial in hospitalized participants with Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) to evaluate the safety, tolerability, preliminary efficacy, PK, and PD of RLS-0071 compared to Placebo in the treatment of AECOPD. The dosing regimen will be 3 times a day for at least 3 days and up to 5 days total if still hospitalized. Participants will be followed for efficacy and safety for 30 and 60 days after the final dose. RLS-0071 or Placebo will be given as add-on therapy to SOC management for acute exacerbations of COPD.
- Being tested
- RLS-0071, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLS-0071Drug
RLS-0071, will be administered as an IV infusion 10 mg/kg. Planned infusion duration is 8 minutes.
PlaceboDrug
Placebo control (commercial sterile saline), will be administered as an IV infusion. Planned infusion duration is 8 minutes.
| Study group | Role | What they receive |
|---|---|---|
| RLS-0071 | Experimental | Doses of RLS-0071, will be administered Q8H, three times a day, for at least 3 days and up to 5 days Receives: Drug: RLS-0071 |
| Placebo | Placebo comparator | Doses of Placebo for RLS-0071, will be administered Q8H, three times a day, for at least 3 days and up to 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Measured: Day 1 to Day 60
Secondary outcomes (15)
Time to reach maximum observed serum concentration (Tmax) for RLS-0071
Measured: Day 1 and Day 3
Maximum Observed Serum Concentration (Cmax) for RLS-0071
Measured: Day 1 and Day 3
Area Under the Curve From Time 0 to Infinity (AUC [0 - infinity]) for RLS-0071
Measured: Day 1 and Day 3
Terminal Phase Elimination Half-Life (t1/2) for RLS-0071
Measured: Day 1 and Day 3
Evaluate the change in plasma neutrophil counts from Day 0 up to Day 5.
Measured: Day 0 up to Day 5.
Evaluate the change from baseline in eosinophil counts from Day 0 up to Day 5.
Measured: Day 0 up to Day 5.
Evaluate the change from baseline in erythrocyte sedimentation rate from Day 0 up to Day 5.
Measured: Day 0 up to Day 5.
Evaluate the change in baseline in c-reactive protein in blood from Day 0 up to Day 5.
Measured: Day 0 up to Day 5.
Number of days participant was hospitalized (length of stay).
Measured: Day 1 - Day 60
Number of participants rehospitalized for COPD up to Day 60
Measured: Day 1 to Day 60
Number of participants that progressed to mechanical ventilation
Measured: Day 1 - Day 5
Mortality rate of participants at 60 days after discharge
Measured: Day 1 to Day 60
Measure heart rate via beats per minute daily
Measured: Day 1 - Up to Day 5
Measure respiratory rate by measuring breaths per minute daily
Measured: Day 1 - Up to Day 5
Measure the % O2 saturation via pulse oximetry daily
Measured: Day 1 - Up to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start25 Jan 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReAlta Life Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175065
- Sponsor's protocol ID
- RLS-0071-204
- Status last verified
- May 2025
- First submitted
- 29 Nov 2023
- Last updated
- 8 May 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Randomized, Doubled-Blind, Placebo-Controlled Trial to Evaluate Safety, Pharmacokinetics and Pharmacokinetic-Pharmacodynamic Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06175065
- Acronym / sponsor ID
- RLS-0071-204
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- ReAlta Life Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 18 Dec 2023 (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.
AECOPD is a major cause of hospital admission and mortality. They contribute to long-term decline in lung function, physical capacity, and quality of life (QoL). RLS-0071 is a novel peptide being developed for the treatment of AECOPD. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of adults with moderate exacerbations of COPD.
Detailed description
This is a randomized, double-blind, placebo controlled trial in hospitalized participants with Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) to evaluate the safety, tolerability, preliminary efficacy, PK, and PD of RLS-0071 compared to Placebo in the treatment of AECOPD. The dosing regimen will be 3 times a day for at least 3 days and up to 5 days total if still hospitalized. Participants will be followed for efficacy and safety for 30 and 60 days after the final dose. RLS-0071 or Placebo will be given as add-on therapy to SOC management for acute exacerbations of COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RLS-0071 | Experimental | Drug: RLS-0071Doses of RLS-0071, will be administered Q8H, three times a day, for at least 3 days and up to 5 days |
| Placebo | Placebo comparator | Drug: PlaceboDoses of Placebo for RLS-0071, will be administered Q8H, three times a day, for at least 3 days and up to 5 days |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized participants with a prior diagnosis of COPD including spirometry within the prior year documenting a postbronchodilator FEV1/FVC ≤ 0.7 and an FEV1
- ≤ 80%, and a clinician identified admitting diagnosis of AECOPD: acute increase in dyspnea, sputum volume or purulence - without other attributable cause.
- Participants must have a moderate exacerbation of COPD according to the Rome guidelines
- ≥ 10 pack-years smoking history.
Key exclusion criteria (18 listed)
- Endotracheal intubation or mechanical ventilation.
- Participants with severe exacerbation of COPD according to the Rome guidelines
- Participants with signs and symptoms consistent with an alternative diagnosis for worsening of pulmonary status
- Interstitial lung disease.
- Current or prior history of asthma.
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 |
|---|---|---|
| RLS-0071RLS-0071, will be administered as an IV infusion 10 mg/kg. Planned infusion duration is 8 minutes. | Drug | RLS-0071 |
| PlaceboPlacebo control (commercial sterile saline), will be administered as an IV infusion. Planned infusion duration is 8 minutes. | Drug | Placebo |
Primary outcome
Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 to Day 60
15 secondary outcomes
Time to reach maximum observed serum concentration (Tmax) for RLS-0071
Time frame: Day 1 and Day 3
Maximum Observed Serum Concentration (Cmax) for RLS-0071
Time frame: Day 1 and Day 3
Area Under the Curve From Time 0 to Infinity (AUC [0 - infinity]) for RLS-0071
Time frame: Day 1 and Day 3
Terminal Phase Elimination Half-Life (t1/2) for RLS-0071
Time frame: Day 1 and Day 3
Evaluate the change in plasma neutrophil counts from Day 0 up to Day 5.
Time frame: Day 0 up to Day 5.
Evaluate the change from baseline in eosinophil counts from Day 0 up to Day 5.
Time frame: Day 0 up to Day 5.
Evaluate the change from baseline in erythrocyte sedimentation rate from Day 0 up to Day 5.
Time frame: Day 0 up to Day 5.
Evaluate the change in baseline in c-reactive protein in blood from Day 0 up to Day 5.
Time frame: Day 0 up to Day 5.
Number of days participant was hospitalized (length of stay).
Time frame: Day 1 - Day 60
Number of participants rehospitalized for COPD up to Day 60
Time frame: Day 1 to Day 60
Number of participants that progressed to mechanical ventilation
Time frame: Day 1 - Day 5
Mortality rate of participants at 60 days after discharge
Time frame: Day 1 to Day 60
Measure heart rate via beats per minute daily
Time frame: Day 1 - Up to Day 5
Measure respiratory rate by measuring breaths per minute daily
Time frame: Day 1 - Up to Day 5
Measure the % O2 saturation via pulse oximetry daily
Time frame: Day 1 - Up to Day 5
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 8 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 RLS-0071 in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by ReAlta Life Sciences, Inc. at 4 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 4 inclusion and 18 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 8 May 2025. 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. 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. Some participants in this study may receive a placebo. 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?
Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) (time frame: Day 1 to Day 60). 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 8 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.