Buloxibutid for Pulmonary Fibrosis
(ASPIRE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called buloxibutid for individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring and breathing problems. The trial aims to evaluate the effectiveness and safety of the medicine, either alone or with other IPF treatments. Participants will receive either buloxibutid or a placebo (a non-active substance) for 52 weeks. Those who have had IPF for less than 7 years and are either on a stable IPF treatment or not on any treatment might be suitable candidates. For more details, visit www.aspire-ipf.com. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
If you are on a stable dose of licensed IPF therapy, you can continue taking it during the trial, except for pirfenidone, which is not allowed. If you are not currently on IPF treatment, any previous IPF therapy must have been stopped more than 8 weeks before joining the trial.
Is there any evidence suggesting that buloxibutid is likely to be safe for humans?
Research has shown that buloxibutid is safe and well-tolerated in previous studies. In a 36-week trial, mild-to-moderate hair loss was the main side effect, which resolved after discontinuing the treatment. No other major side effects were reported. These findings suggest that buloxibutid could be a promising option for people with idiopathic pulmonary fibrosis (IPF).12345
Why do researchers think this study treatment might be promising?
Most treatments for pulmonary fibrosis, like pirfenidone and nintedanib, work by slowing disease progression. But Buloxibutid is unique because it targets a different pathway that may directly impact lung tissue repair. Researchers are excited about Buloxibutid because it offers a new mechanism of action that could potentially improve lung function more effectively. With its novel approach and the possibility of better outcomes for patients, Buloxibutid stands out as a promising new option in the fight against this challenging condition.
What evidence suggests that buloxibutid might be an effective treatment for pulmonary fibrosis?
Studies have shown that buloxibutid, an oral medication, can help people with idiopathic pulmonary fibrosis (IPF) breathe better. This medication activates a specific mechanism in the body that protects the lungs from damage. In a previous study, patients who took buloxibutid showed noticeable improvements in lung health over 36 weeks. These findings suggest that buloxibutid might slow lung damage in people with IPF. The trial will evaluate different dosages of buloxibutid, specifically 100 mg and 50 mg taken twice daily, compared to a placebo, over a 52-week period. This offers hope for those facing this challenging condition.16789
Who Is on the Research Team?
Cecilia Ganslandt, MD
Principal Investigator
Vicore Pharma AB
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either buloxibutid 100 mg BID, buloxibutid 50 mg BID, or placebo BID for 52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Buloxibutid
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vicore Pharma AB
Lead Sponsor
Population Services International
Collaborator