Not recruiting

Study on the Effects of ARO-MUC5AC Inhalation Solution for Patients with Asthma and COPD

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment called ARO-MUC5AC Inhalation Solution in individuals with Asthma and Chronic Obstructive Pulmonary Disease (COPD), as well as in healthy volunteers. The treatment involves an inhalation solution that contains a special substance known as ADS-013, which is designed to help manage lung conditions by targeting specific proteins in the body. The study also uses a device called the Pari eFlow nebulizer to deliver the inhalation solution.

The purpose of the study is to assess the safety and tolerability of the ARO-MUC5AC treatment. Participants will receive either the ARO-MUC5AC Inhalation Solution or a placebo. The study will be conducted over a period of time, during which participants will be monitored for any side effects and changes in their lung function. This will involve regular check-ups and assessments to ensure the treatment is safe and well-tolerated.

Throughout the study, researchers will collect information on how the treatment affects lung function, specifically looking at measures like forced expiratory volume (FEV1) and forced vital capacity (FVC). These are common tests used to assess how well the lungs are working. The study aims to provide valuable insights into the potential benefits and safety of the ARO-MUC5AC Inhalation Solution for people with muco-obstructive lung diseases like asthma and COPD.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.
A chest x-ray and a 12-lead ECG are performed to ensure there are no significant respiratory diseases or heart abnormalities.
Step 2
Baseline measurements
Baseline measurements are taken, including lung function tests such as forced expiratory volume (FEV1) and forced vital capacity (FVC).
These measurements help establish a starting point for evaluating the effects of the treatment.
Step 3
Treatment administration
The treatment involves the use of ARO-MUC5AC Inhalation Solution, administered via inhalation.
The dosage and frequency of administration are determined by the study protocol and are monitored closely throughout the trial.
Step 4
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor health and any potential side effects.
Lung function tests are repeated to assess changes from baseline measurements.
Step 5
End of study evaluation
At the end of the study, a final evaluation is conducted to assess the overall effects of the treatment.
This includes a review of any adverse events and changes in lung function.

Who can join the trial?

27 criteria

Asthma Cohorts: Must be a male or a nonpregnant, nonlactating female volunteer.
Asthma Cohorts: Age between 18 to 65 years at the time of screening.
Asthma Cohorts: Must have a confirmed diagnosis of asthma for at least 12 months before screening.
Asthma Cohorts: Must be on a daily dose of inhaled corticosteroids of at least 500 mcg for at least 3 months before screening.
Asthma Cohorts: Must be using at least one additional asthma controller medication for at least 3 months before screening.
Asthma Cohorts: Lung function test (ppFEV1) should be between 40% and 80% before taking a bronchodilator at screening.
Asthma Cohorts: Must have a stable dose of asthma medications for at least 28 days before screening.
Asthma Cohorts: If receiving allergen-specific immunotherapy, must be on a stable dose for at least 90 days before the first dose.
Asthma Cohorts: If on biologic therapy for asthma, must be on a stable dose for at least 16 weeks before the first dose.
Asthma Cohorts: Must have a chest x-ray at screening that shows no significant other lung diseases.
Asthma Cohorts: Must be able and willing to provide written consent before any study procedures.
Asthma Cohorts: Body Mass Index (BMI) should be between 18.0 and 35.0 at screening.
Asthma Cohorts: Must have a normal heart test (ECG) at screening that does not show any safety concerns.
Asthma Cohorts: Must be a nonsmoker for at least 6 months, with a smoking history of less than 10 pack-years.
COPD Cohorts: Must be a male or a nonpregnant, nonlactating female volunteer.
COPD Cohorts: Age between 40 to 70 years at the time of screening.
COPD Cohorts: Must have a confirmed diagnosis of COPD for at least 12 months before screening.
COPD Cohorts: Must have a history of chronic bronchitis, which means having a cough and phlegm most days or several days a week.
COPD Cohorts: Must be a current smoker or an ex-smoker with a smoking history of at least 10 pack-years.
COPD Cohorts: Lung function test (ppFEV1) should be between 40% and 80% after taking a bronchodilator at screening.
COPD Cohorts: Must be on stable COPD treatment for at least 1 month before screening.
COPD Cohorts: Must be able and willing to provide written consent before any study procedures.
COPD Cohorts: Body Mass Index (BMI) should be between 18.0 and 35.0 at screening.
COPD Cohorts: Must have a normal heart test (ECG) at screening that does not show any safety concerns.
COPD Cohorts: Participants who can have children must agree to use effective birth control during the study and for 90 days after.
COPD Cohorts: Must be able and willing to follow all study procedures and schedules.
COPD Cohorts: Must be able to provide a good quality sputum sample at screening.

Who cannot join the trial?

3 criteria

People with **asthma** or **chronic obstructive pulmonary disease (COPD)** cannot participate. **Asthma** is a condition where the airways in the lungs become narrow and swollen, making it hard to breathe. **COPD** is a long-term lung disease that makes it difficult to breathe.
Individuals who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Participants who are considered part of a **vulnerable population** cannot join. A **vulnerable population** includes people who might need special protection or care, such as children, pregnant women, or those with certain health conditions.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Medicome Sp. z o.o.
Oświęcim, Poland
Verified
Prywatny Gabinet Internistyczno-Alergologiczny Zenon Siergiejko
Bialystok, Poland

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Investigated drugs

ARO-MUC5AC is an inhalation solution being studied for its effects on people with muco-obstructive lung disease. This medication is designed to help manage symptoms by targeting and reducing mucus production in the lungs, which can improve breathing and overall lung function. The trial aims to evaluate how safe and tolerable this treatment is for both healthy individuals and patients with lung conditions.

Ads-013

What is already known about the treatment

ARO-MUC5AC – This medication is administered as an inhalation solution, designed for use in individuals with muco-obstructive lung diseases such as asthma and chronic obstructive pulmonary disease (COPD). Currently, it is being evaluated in clinical trials to determine its safety and tolerability. The main therapeutic indication is to help manage symptoms associated with these lung conditions. At the molecular level, ARO-MUC5AC works by targeting and reducing the production of a specific mucus protein, which can help clear mucus from the lungs. It is classified pharmacologically as a respiratory agent.

Investigated diseases

Asthma
Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. It often presents with symptoms such as wheezing, coughing, shortness of breath, and chest tightness. These symptoms can vary in intensity and may be triggered by allergens, exercise, cold air, or stress. Asthma can progress with episodes known as asthma attacks, where symptoms become more severe. The condition can fluctuate over time, with periods of exacerbation and remission. Management typically involves avoiding triggers and monitoring symptoms to prevent attacks.
Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease is a progressive lung disease that causes obstructed airflow from the lungs. It is primarily caused by long-term exposure to irritating gases or particulate matter, most often from cigarette smoke. Symptoms include breathing difficulty, cough, mucus production, and wheezing. COPD develops slowly over years and can lead to increasing breathlessness. The disease is characterized by episodes of exacerbation, where symptoms worsen and may require additional care. It is important to manage environmental factors and monitor lung function to slow progression.