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Peptide

RLS-0071 for COPD

Phase 2

Recruiting

Research Sponsored by ReAlta Life Sciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 - day 60

Awards & highlights

Study Summary

This trial is studying a new treatment called RLS-0071 for adults with moderate exacerbations of COPD, which is a serious lung condition that can cause hospitalization and even death. Exacerb

Who is the study for?

This trial is for adults with moderate COPD flare-ups, who've smoked at least the equivalent of a pack a day for 10 years. They must have been diagnosed with COPD previously, shown by specific lung function tests within the last year and be hospitalized due to their current flare-up.Check my eligibility

What is being tested?

The study is testing RLS-0071, a new peptide treatment for COPD exacerbations. Participants will either receive RLS-0071 or a placebo to assess the safety and how well it works in improving symptoms compared to not receiving the active drug.See study design

What are the potential side effects?

Possible side effects are not detailed but typically include reactions where the drug is administered, potential allergic responses, general discomforts like headaches or nausea, and any other unexpected changes in health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have COPD, confirmed by a lung function test in the last year.

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I have been diagnosed with a severe COPD flare-up without any other known cause.

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I have had a moderate worsening of my COPD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 - day 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 - day 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 - day 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

Secondary outcome measures

Area Under the Curve From Time 0 to Infinity (AUC [0 - infinity]) for RLS-0071

Evaluate the change from baseline in eosinophil counts from Day 0 up to Day 5.

Evaluate the change from baseline in erythrocyte sedimentation rate from Day 0 up to Day 5.

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RLS-0071Experimental Treatment1 Intervention

Doses of RLS-0071, will be administered Q8H, three times a day, for at least 3 days and up to 5 days

Group II: PlaceboPlacebo Group1 Intervention

Doses of Placebo for RLS-0071, will be administered Q8H, three times a day, for at least 3 days and up to 5 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RLS-0071

2021

Completed Phase 1

~60

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

ReAlta Life Sciences, Inc.Lead Sponsor

5 Previous Clinical Trials

194 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has RLS-0071 received the official endorsement of the FDA?

"Our team at Power rates the safety of RLS-0071 as a 2 on a scale from 1 to 3, given that this trial is in Phase 2. This means that there is some available data supporting its safety but no evidence yet regarding efficacy."

Answered by AI

What is the current number of participants being recruited for this research endeavor?

"Indeed, the data provided on clinicaltrials.gov confirms that this trial is actively seeking suitable candidates. The initial posting of the study was made on January 1st, 2024, and it has been updated most recently on January 9th, 2024. This clinical trial aims to enroll a total of 24 patients at a single location."

Answered by AI

Are patients currently eligible to participate in this ongoing medical study?

"Indeed, as stated on clinicaltrials.gov, this study is currently seeking eligible participants. The trial was initially posted on January 1st, 2024 and underwent its most recent update on January 9th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

2024. "Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06175065.

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