Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1/2a Study Evaluating the Effects of ARO-MUC5AC Inhalation Solution in Healthy Subjects and Patients with Muco-Obstructive Lung Disease

Researchers are conducting a study to test a new inhaled medicine called ARO-MUC5AC. This medicine is designed for people who have lung conditions where too much mucus can be a problem, such as asthma and chronic obstructive pulmonary disease (COPD). The main goal is to find out if ARO-MUC5AC is safe for people to use and to keep track of any side effects that might happen. They will compare it to a salt water (saline) solution, which acts as a dummy treatment. The study will also look at how the medicine moves through the body and if it has any effects on lung function, like how much air you can breathe out. This helps doctors understand more about this new potential treatment.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Arrowhead Pharmaceuticals Inc.

Enrolment target

Start

24 Jul 2024

Asthma and Chronic obstructive pulmonary disease

What is this study about?

This research study is looking at a new inhaled medicine, called ARO-MUC5AC, for lung conditions like asthma and chronic obstructive pulmonary disease (COPD). Many people with these conditions produce a lot of thick mucus, which can make breathing difficult. The scientists want to see if this new medicine can help.

The main aim of the study is to check if ARO-MUC5AC is safe to use. This means they will carefully watch for any unwanted or unexpected effects that people experience while taking the medicine. They will compare it to a simple salt water solution to see if any effects are truly due to the new medicine.

Beyond safety, the researchers will also be looking at how the new medicine behaves in the body and if it has any impact on how well your lungs are working. This research is a crucial step to understand if ARO-MUC5AC could be a helpful treatment option for people struggling with mucus-related breathing problems in the future.

Key takeaways

This study is testing a new inhaled medicine (ARO-MUC5AC) for lung conditions.
The main goals are to check if the medicine is safe and identify any side effects.
The study includes adults with asthma and COPD.
You will inhale either the new medicine or a salt water solution.
Participation involves clinic visits, breathing tests, and blood samples.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study welcomes both men and women.

Apart from your age and sex, there will be other important health checks to make sure the study is right for you. For example, if you have asthma or COPD, the study will need to confirm your diagnosis and how well your condition is currently managed.

The research team will carry out a full health review to make sure you meet all the necessary requirements for safety and to ensure the study results are clear. This is important to protect your health and get accurate answers from the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am 18 years old or older.
I am male or female.
I have been diagnosed with asthma or COPD.
I am willing and able to attend clinic visits regularly.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the new medicine, ARO-MUC5AC, or a simple salt solution (which looks exactly the same). You will inhale this medicine as directed.

The study will involve several visits to the clinic over a period of time. During these visits, the research team will perform various health checks, such as measuring your breathing (lung function tests) and taking blood samples. They will also ask you how you are feeling and keep a close eye on any side effects you might experience.

The total duration of your involvement in the study will be explained in detail by the research team if you are interested. There will also be follow-up appointments after you stop taking the study medicine to ensure your continued well-being.

Potential risks and benefits

Taking part in a study like this could potentially help advance our understanding of new treatments for lung conditions. While there's no guarantee of direct personal benefit, your participation helps future patients. As with any new medicine, there's always a possibility of side effects, which the research team will monitor very carefully. You will be fully informed of all known and potential risks before you decide to join. Remember, you can always choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland
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Unverified
Spain

Common questions

What is ARO-MUC5AC?

ARO-MUC5AC is a new medicine being tested as an inhalation solution for lung conditions where thick mucus is a problem.

What are 'side effects'?

Side effects are any unwanted or unexpected reactions to a medicine. The study will carefully record these.

Will I know if I'm getting the real medicine or the salt water?

No, this type of study is 'blinded', meaning neither you nor the study team will know until after the study is complete, to ensure fair results.

Why are they checking my lung function?

Measuring your lung function, like how much air you can breathe out, helps the researchers understand the safety of the medicine and if it has any impact on your breathing.

How long will I be in the study?

The full duration of your participation will be explained by the study team if you are interested in joining.