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Buloxibutid for Pulmonary Fibrosis (ASPIRE Trial)

Phase 2

Recruiting

Research Sponsored by Vicore Pharma AB

Eligibility Criteria Checklist

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

Must have

Diagnosed with IPF within 5 years prior to visit 1, as per ATS/ERS/JRS/ALAT 2022 guidelines

Age ≥ 40 years at the time of signing the informed consent

Must not have

Lower respiratory tract infection requiring antibiotics within 4 weeks prior to visit 2

Known impaired hepatic function or clinically significant liver disease at visit 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Summary

This trial is testing a new drug called buloxibutid for the treatment of Idiopathic Pulmonary Fibrosis (IPF). It will last for 52 weeks and involve participants taking the

Who is the study for?

This trial is for people with Idiopathic Pulmonary Fibrosis (IPF), a type of lung scarring. Participants can be on stable IPF therapy or not, but must meet certain health standards to join. Specific inclusion and exclusion criteria details are missing here, so check www.aspire-ipf.com for more info.

What is being tested?

The ASPIRE trial tests the effectiveness and safety of Buloxibutid taken orally, compared to a placebo. It's designed as a double-blind study where neither participants nor researchers know who gets the real drug versus placebo over 52 weeks.

What are the potential side effects?

While specific side effects aren't listed here, typical ones may include digestive issues, skin reactions, or liver problems due to medication intake. Check the trial website or contact organizers at www.aspire-ipf.com for detailed side effect information.

Eligibility Criteria

Inclusion Criteria

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

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I was diagnosed with IPF within the last 5 years.

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I am 40 years old or older.

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I expect to live more than a year and don't need a lung transplant soon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a lung infection needing antibiotics in the last 4 weeks.

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I have liver problems or a significant liver disease.

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I haven't had severe heart issues or uncontrolled high blood pressure in the last 6 months.

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I have severe kidney problems.

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My heart's electrical activity is normal.

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I am currently pregnant or breastfeeding.

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I have had a sudden worsening of my lung condition in the last 3 months.

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I have not taken pirfenidone in the last 8 weeks and do not plan to during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate the efficacy of buloxibutid compared to placebo in participants with IPF as assessed by FVC

Secondary study objectives

To further evaluate the effects of buloxibutid on disease progression, respiratory-related hospitalization or death compared to placebo in participants with IPF