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ASPIRE
A late-stage clinical trial to evaluate the safety and efficacy of the investigational drug buloxibutid (also known as C21) in patients with idiopathic pulmonary fibrosis (IPF).
The ASPIRE trial will examine whether the trial drug can slow down or halt the progression of lung fibrosis by measuring the breathing capacity through lung function tests. The trial will also look at other efficacy and safety measures, including quality of life. Two different doses of the investigational drug will be compared to placebo over a period of approximately one year. In the ASPIRE trial, two of every three participants will take buloxibutid daily.
Information about ASPIRE
The ASPIRE trial is a phase 2b trial which expands the research to a larger group of patients to further evaluate the treatment’s effectiveness, side effects, and best dosages. This trial is following earlier clinical trials in healthy volunteers as well as patients with IPF, including the phase 2a AIR trial where buloxibutid was given for a 36-week period. Your doctor may inform you about the reported results from these trials.
What is buloxibutid?
Buloxibutid is an investigational drug and is not approved by any health authority. It is an oral medicine, designed to activate a natural repair system in the lungs to address the scarring seen in lung fibrosis.
What does participation involve?
Eligibility
People who are 40 years or older, diagnosed with IPF and either on a stable dose of nintedanib or not currently receiving licensed IPF treatment for any reason, can participate in this trial. Further eligibility criteria apply and will be evaluated during the screening period.
Structure
The trial involves three stages: a screening period (up to 6 weeks) where your eligibility criteria will be assessed, a 52-week treatment period, and a 2–4-week follow-up after the last dose.
Visits
There will be 8 site visits and 8 phone or video calls for safety assessments and to monitor medication use.
Treatment groups
Participants will be randomly assigned to one of three groups; buloxibutid 50 mg, buloxibutid 100 mg, or a placebo (which looks identical to buloxibutid but contains no active medication), taken twice daily.
Potential benefits of participation
People participate in clinical trials for various reasons. Some see the regular medical evaluations and close monitoring by healthcare professionals during a trial as the main benefit of participation. Others participate for the possibility to receive a new, potentially beneficial, treatment in a clinical trial before it is widely available. Many are encouraged by friends or relatives or simply want to have a more active role, learn more about their disease and help advance scientific knowledge in diseases such as IPF, where treatment options are limited.
Important considerations
Buloxibutid may affect blood levels of other drugs and therefore patients treated with certain medications (for example pirfenidone) cannot participate in this trial. Your doctor can review your current medicine list for further guidance.
Potential risks of participation
Regardless of treatment group, your IPF symptoms or condition may not improve or get worse during the trial period. Buloxibutid is an investigational drug and as with any trial drug, side effects, including those not yet known, may occur. Previously observed side effects include reversible hair loss, headache, nausea, dizziness and feelings of being tired. You may experience some, all, or none of the listed side effects.
How is patient safety monitored?
Clinical trials follow strict scientific standards to protect you as a participant and help produce reliable trial results. ASPIRE is approved by national health authorities and ethics committees or institutional review boards. Side effects will be continuously monitored to ensure your safety throughout the trial.
Trial visit schedule
As a participant in the ASPIRE trial, your involvement will include a series of scheduled visits to the clinic complemented with regular phone or video calls. This approach ensures close monitoring of your health and wellbeing as well as the efficacy and safety of the investigational drug throughout the trial period. The phone or video calls offer some flexibility and will be scheduled to complement the in-person clinic visits.
Clinic visit
In-person visit to the clinic
Blood sampling
To monitor efficacy and safety of treatment.
Lung & heart function test
To assess impact of treatment on lung capacity and heart function.
Physical examination
Includes different examinations done during clinic visits.
Questionnaires
Self-reported assessments to capture symptoms and impact on your daily life and overall wellbeing.
Phone/video call
To maintain regular contact, ensure your wellbeing and adherence to treatment.
Locations
Click the interactive map to find locations where the ASPIRE trial is actively recruiting participants.
Frequently Asked Questions
How will I know if the treatment is working for me?
The effectiveness and safety of the trial drug will be assessed through regular health evaluations, including lung function tests and quality of life assessments.
Will I receive compensation for participating?
You will not be paid for your participation in this trial, but you will receive the trial drug (or placebo) and related procedures at no cost. You will be reimbursed for reasonable travel and meal expenses related to attending the trial site visits.
What happens if I no longer want to participate?
You are free to withdraw from the trial at any time without any impact on your future medical care. If you choose to withdraw, your trial doctor will ask you to attend all the remaining trial visits. However, it is not mandatory that you participate in these visits.
How will my privacy be protected during the trial?
Your personal and health information will be kept confidential and secure, in accordance with privacy laws. Data collected will be used for research purposes only, and identifying details will be removed in any shared or published results.