Now enrolling:
The ASPIRE IPF trial

Idiopathic pulmonary fibrosis (IPF) is a rare lung disease characterized by the scarring of lung tissue. The scarring happens around the tiny air sacs in the lungs called alveoli, where oxygen and carbon dioxide are exchanged, often making it difficult for patients to breathe. When the cause of disease is unknown, fibrosis may be termed ‘idiopathic’.

Buloxibutid is a new oral investigational medicine, designed to activate a natural repair system to reduce scar formation (fibrosis) in the lungs of people with IPF. As an investigational drug it is not approved by any health authority.

You will undergo regular health evaluations, including lung function tests and quality of life assessments among other examinations and tests to assess the effectiveness and safety of the trial drug.

Once the trial is completed and analyses of assessments, examinations and tests have been done for all patients in the trial, the results will be made available to you as a participant.

Patients treated with a stable dose of nintedanib (Ofev) are able to join this trial and continue on treatment. Buloxibutid may affect blood levels of other drugs and therefore patients treated with certain medications (for example pirfenidone, also known as Esbriet) cannot participate in this trial. Your doctor will review your current medication list for further guidance.

You will receive the trial drug (or placebo) as well as trial related examinations and tests at no cost. You will be reimbursed for reasonable travel and meal expenses related to attending the trial site clinic visits.

The purpose of the informed consent process is to give you the opportunity to be an informed participant in your healthcare decisions during a clinical trial. You should be aware of all details prior to participating, including what to expect at trial visits, how to take the trial drug, the potential risks and benefits of participation, among other things. Written information will be provided for your review, and you will be able to share this with your family and friends. You will also meet with your trial doctor and the study team to review all details and ask any questions you might have.

Once you agree to join the trial, you will be asked to sign an informed consent form to confirm that you freely agree to taking part in the trial. Even after signing the informed consent form, you are free to leave the trial at any time and for any reason.

Regardless of treatment group, your IPF symptoms or condition may not improve or get worse during the trial period. As with any investigational drug, side effects, including those not yet known, may occur. Your safety will be continuously monitored throughout the trial.

You are free to withdraw from the trial at any time without any impact on your future medical care. Your doctor will continue to provide care and can advise you about alternative options. 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.

The optimal dose of the trial drug cannot be determined until the final analysis of the trial results. Therefore, there are currently no plans on providing access to buloxibutid after the trial. Expanded access may be considered at a later stage of development.

Clinical trials follow strict scientific standards to protect you as a participant and help produce reliable trial results. The ASPIRE IPF trial 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.

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.

One third of trial participants will be randomly selected to take a placebo (which looks identical to the study drug but contains no active medication). Trial participants and staff will not know who is taking the placebo. This is done to prevent bias and to understand if the investigational drug is working.

To prevent bias and unfairness, neither you as a participant, nor trial doctors or nurses will know if you are taking one of the doses of the investigational drug or placebo until after the trial is finished.