RLS-0071 for COPD

Recruiting at 4 trial locations

Overseen By Claire Whitaker

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ReAlta Life Sciences, Inc.

Must not be taking: Chronic steroids

Disqualifiers: Asthma, Autoimmune disease, Heart failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

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.

Inclusion Criteria

You have smoked the equivalent of 10 packs of cigarettes per year for at least one year.

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive RLS-0071 or placebo three times a day for at least 3 days and up to 5 days

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 days

Treatment Details

Interventions

• RLS-0071

Trial Overview 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.

Participant Groups

Group I: RLS-0071 Experimental Treatment 1 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: Placebo Placebo Group 1 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

RLS-0071 is already approved in United States for the following indications:

Approved in United States as RLS-0071 for:

• Hypoxic-ischemic encephalopathy (HIE) in neonates - Fast Track designation, not yet approved

Who Is Running the Clinical Trial?

ReAlta Life Sciences, Inc.

Lead Sponsor

Trials

6

Recruited

220+