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Buloxibutid

The ASPIRE trial is a groundbreaking study exploring the potential of Buloxibutid, a new oral medication, in treating Idiopathic Pulmonary Fibrosis (IPF). This 52-week clinical trial aims to assess the efficacy, safety, and pharmacokinetics of Buloxibutid in patients with IPF. The study involves 270 participants and compares two different doses of Buloxibutid against a placebo, offering hope for those affected by this challenging lung condition.

Table of Contents

What is Buloxibutid?

Buloxibutid, also known as C21, is a new medication being studied for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is a serious lung disease that causes scarring (fibrosis) of the lungs, making it difficult to breathe.[1]

How Does Buloxibutid Work?

Buloxibutid is an oral medication that works by activating a specific receptor in the lungs called the angiotensin II type 2 (AT2) receptor. This receptor is found on important lung cells called alveolar epithelial type 2 cells (AEC2s), which play a crucial role in maintaining healthy lungs.[1]

Research has shown that Buloxibutid may help in several ways:

  • Improving the survival of AEC2 cells
  • Enhancing the integrity of air sacs in the lungs by promoting surfactant secretion (a substance that helps keep the lungs open)
  • Supporting the repair of lung tissue
  • Reducing the formation of scar tissue
  • Helping to break down existing scar tissue
  • Addressing blood vessel problems associated with IPF

The ASPIRE Trial: Testing Buloxibutid’s Effectiveness

To determine if Buloxibutid is safe and effective for treating IPF, researchers are conducting a clinical trial called ASPIRE. This trial is designed to evaluate how well the medication works and if it’s safe for patients to use.[1]

Key features of the ASPIRE trial include:

  • Duration: 52 weeks (1 year)
  • Type: Randomized, double-blind, placebo-controlled study
  • Participants: 270 people with IPF
  • Treatment groups:
    1. 90 participants receiving 100 mg of Buloxibutid twice daily
    2. 90 participants receiving 50 mg of Buloxibutid twice daily
    3. 90 participants receiving a placebo (a pill with no active medication) twice daily

Who Can Participate in the Trial?

The ASPIRE trial is open to people with IPF who are:[1]

  • Currently on stable, approved IPF therapy
  • Not currently receiving any approved IPF therapy, including those who:
    • Cannot tolerate or do not respond to approved therapies
    • Are not eligible for approved therapies
    • Have chosen not to receive approved therapies after being informed of the potential benefits and risks

It’s important to note that participants cannot take pirfenidone (another IPF medication) during the trial due to potential drug interactions. However, those not on anti-fibrotic therapy at the start of the study may begin such treatment during the trial if needed.[1]

Trial Structure and Measurements

The ASPIRE trial is divided into three main parts:[1]

  1. Screening period: Up to 6 weeks
  2. Treatment period: 52 weeks
  3. Follow-up period: 2-4 weeks after the 52-week visit

The primary measurement used to assess the effectiveness of Buloxibutid is spirometry, which measures lung function. Specifically, researchers will look at the forced vital capacity (FVC), which is the amount of air a person can forcefully exhale after taking a deep breath.[1]

Potential Benefits of Buloxibutid

While the full results of the ASPIRE trial are not yet known, earlier studies have shown promising results. Buloxibutid has been found to improve lung function in people with IPF over a 36-week period.[1]

Researchers hope that Buloxibutid will provide several benefits for people with IPF, including:

  • Slowing the progression of the disease
  • Improving lung function
  • Reducing the risk of respiratory-related hospitalizations
  • Potentially improving survival rates

It’s important to remember that Buloxibutid is still being studied, and more research is needed to fully understand its effectiveness and safety. The ASPIRE trial will provide valuable information about this potential new treatment for IPF.[1]

Aspect Details
Trial Name ASPIRE
Drug Tested Buloxibutid
Condition Idiopathic Pulmonary Fibrosis (IPF)
Trial Duration 52 weeks
Number of Participants 270
Treatment Groups 100 mg Buloxibutid BID, 50 mg Buloxibutid BID, Placebo BID
Primary Outcome Measure Change in Forced Vital Capacity (FVC)
Secondary Outcome Measures Disease progression, respiratory-related hospitalization, death
Mechanism of Action AT2 receptor agonist, improving AEC2 cell function

FAQ

  • What is Buloxibutid and how does it work? Buloxibutid is an oral medication that acts as an angiotensin II type 2 (AT2) receptor agonist. It works by improving the health of important lung cells called alveolar epithelial type 2 cells (AEC2s), which play a crucial role in maintaining lung function in IPF patients.
  • Who can participate in the ASPIRE trial? The trial includes participants who are on stable licensed IPF therapy and those who are not currently treated with licensed IPF therapy. This includes people who can't tolerate or don't respond to existing treatments, those not eligible for current therapies, and those who have chosen not to receive licensed IPF therapy after being informed of the risks and benefits.
  • How long does the ASPIRE trial last? The ASPIRE trial lasts for 52 weeks (about one year) of treatment, followed by a 2-4 week follow-up period. There is also a screening period of up to 6 weeks before the treatment begins.
  • What are the different treatment groups in the trial? There are three treatment groups in the trial: one group receives 100 mg of Buloxibutid twice daily, another group receives 50 mg of Buloxibutid twice daily, and the third group receives a placebo twice daily. Each group has 90 participants.
  • How is the effectiveness of Buloxibutid measured in this trial? The primary measure of effectiveness is the change in forced vital capacity (FVC), which is a measure of lung function. The trial will look at the absolute change in FVC from the start of the trial to week 52. Additionally, the study will assess disease progression, respiratory-related hospitalizations, and survival rates.

Ongoing Clinical Trials on Buloxibutid

  • Study on the Effects and Safety of Buloxibutid for Patients with Idiopathic Pulmonary Fibrosis

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Germany Greece Italy Poland

Glossary

  • Idiopathic Pulmonary Fibrosis (IPF): A chronic lung disease characterized by the formation of scar tissue in the lungs, making it difficult to breathe. The cause is unknown, hence 'idiopathic'.
  • Buloxibutid: An oral medication being tested for the treatment of IPF. It works by activating certain receptors in lung cells to potentially improve lung function.
  • Forced Vital Capacity (FVC): A measure of lung function that represents the total amount of air a person can forcefully exhale after taking a deep breath.
  • Angiotensin II type 2 (AT2) receptor agonist: A type of drug that activates AT2 receptors, which in this case may help improve the function of certain lung cells.
  • Alveolar epithelial type 2 cells (AEC2s): Important cells in the lungs that produce surfactant, a substance that helps keep air sacs open, and can develop into other types of lung cells.
  • Randomized, double-blind, placebo-controlled trial: A type of clinical study where participants are randomly assigned to different treatment groups, neither the participants nor the researchers know who is receiving which treatment, and one group receives an inactive substance (placebo) for comparison.
  • Pharmacokinetics: The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.
  • Spirometry: A common lung function test that measures how much air a person can breathe out and how quickly.

References

  1. https://clinicaltrials.gov/study/NCT06588686