All studies
RecruitingPHASE2INTERVENTIONAL

Study to Assess the Efficacy, Safety, and Tolerability of NOC-110 in Adults With Refractory or Unexplained Chronic Cough

This study is testing a new inhaled medicine called NOC-110 for adults who have a long-lasting cough that hasn't gone away despite treatment, or for which doctors can't find a clear cause. It's a 'Phase 2' study, which means it's one of the earlier stages of testing new drugs. Researchers want to find out if NOC-110 helps reduce coughing, how safe it is, and if people can tolerate it well. Some participants will receive the active medicine, while others will receive a dummy medicine (placebo) to fairly compare the results. The study will last about 13 weeks in total.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Nocion Therapeutics
Enrolment target
455
Start
24 Sep 2024
Estimated completion
10 Apr 2026

What is this study about?

If you've been living with a persistent cough that just won't clear up, even after trying different treatments, you might have what doctors call a 'refractory' or 'unexplained chronic cough'. This type of cough can be really disruptive to daily life, affecting sleep, work, and social activities. Doctors are always looking for better ways to help people in this situation.

This particular study is focusing on a new medicine called NOC-110, which is given as an inhalation powder. The main goal is to see if this new medicine can safely and effectively reduce this kind of long-lasting cough. Because it's a 'Phase 2' study, it means it's still relatively early in the testing process, but it's an important step toward potentially making a new treatment available.

The study is designed to be very careful and fair. Some people will receive the new medicine, NOC-110, while others will receive a 'placebo' – which looks and feels like the real medicine but contains no active drug. This helps the researchers understand if any improvements are truly due to NOC-110 or if they might happen anyway. Neither you nor your study doctor will know whether you're getting the medicine or the placebo, to ensure the results are as unbiased as possible. Over about 13 weeks, researchers will keep a close eye on your cough and overall health.

Key takeaways

  • This study is for adults with a stubborn, long-lasting cough.
  • It's testing a new inhaled medicine called NOC-110.
  • You might get the active medicine or a dummy one (placebo).
  • The study lasts about 13 weeks, with regular clinic visits.
  • Participation is voluntary, and you can leave at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old who has had a chronic cough for at least 12 months that hasn't responded to treatment or has no clear cause. If you are a woman who could become pregnant, or a man whose partner could become pregnant, you would need to agree to use specific birth control methods throughout the study.

There are several reasons why you might not be able to join. For example, if you've ever taken the study medicine before, or if you're allergic to it, you wouldn't be eligible. You also can't be in another drug study at the same time, or have been in another cough study recently. If you have certain other health conditions like severe lung diseases (such as COPD or asthma), unexplained lung scarring, or a recent chest infection, you wouldn't qualify. Those who currently smoke or vape, or have stopped very recently, also cannot take part. Additionally, if you're pregnant, breastfeeding, or planning to become pregnant, you cannot join.

Other reasons that might prevent you from joining include a history of certain serious illnesses like cancer in the last two years, poorly controlled heart, kidney, or other major health conditions, a high BMI (over 40), or if you're unable to avoid certain cough medicines during the study. The study also cannot accept individuals with HIV, Hepatitis B or C, or those with certain drug or alcohol issues in the last two years.

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.

  1. Are you an adult aged 18 to 80 years old?
  2. Have you had a cough for at least 12 months that hasn't cleared up or has no known cause?
  3. Are you able to use birth control if needed during the study?
  4. Do you currently smoke or vape, or have you stopped within the last 6 months?
  5. Do you have other serious uncontrolled health conditions, like severe asthma or heart disease?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure you meet all the requirements. This could involve medical checks and answering questions about your health history. The study itself would last for about 13 weeks. During this time, you would attend several appointments at the study clinic. These visits would involve taking the study medicine (either NOC-110 or a dummy medicine), having medical assessments, and discussing how you are feeling and if your cough has changed. You'd be monitored closely to check for any side effects and to see how the medicine is affecting your cough. The full details of the schedule and different assessments would be explained to you before you agree to participate.

Potential risks and benefits

Taking part in a clinical study means you might receive a new treatment that could potentially help your chronic cough, but it's important to remember that it's not guaranteed to work, and the medicine is still being investigated. You might also receive a placebo, which means you wouldn't get the active treatment. There's a chance you could experience side effects from the study medicine, even though medical teams will monitor you very carefully. Before you agree to participate, you will be given a detailed explanation of all known potential risks and benefits. Please remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (107)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • G & L Research, LLC
    Verified postcode
    Foley, United States· Recruiting
  • Medical Research of Arizona
    Verified postcode
    Scottsdale, United States· Recruiting
  • AMR Phoenix
    Verified postcode
    Tempe, United States· Recruiting
  • Little Rock Allergy & Asthma, P.A. Clinical Research Center
    Verified postcode
    Little Rock, United States· Recruiting
  • So Cal Clinical Research
    Verified postcode
    Huntington Beach, United States· Recruiting
  • Allergy and Asthma Associates of Southern California dba Southern California Research
    Verified postcode
    Laguna Niguel, United States· Recruiting
  • Paradigm Clinical Research Centers, LLC - Modesto
    Verified postcode
    Modesto, United States· Recruiting
  • NewportNativeMD,Inc
    Verified postcode
    Newport Beach, United States· Recruiting
  • Center for Clinical Trials, LLC
    Verified postcode
    Paramount, United States· Recruiting
  • Paradigm Clinical Research Centers, LLC
    Verified postcode
    Redding, United States· Recruiting
  • DaVinci Research LLC.
    Verified postcode
    Roseville, United States· Recruiting
  • Allergy & Asthma Associates of Santa Clara Valley
    Verified postcode
    San Jose, United States· Recruiting

Common questions

What is 'refractory' or 'unexplained chronic cough'?

It's a long-lasting cough that hasn't improved with usual treatments, or when doctors can't find a clear reason for it.

What is NOC-110?

It's a new medicine, given as an inhaled powder, that researchers are testing for chronic cough.

What does 'Phase 2' study mean?

It's an early stage of testing a new medicine in a larger group of people to see if it's safe and effective, after initial safety tests.

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

No, during the study, neither you nor your study doctor will know whether you're receiving the active medicine or a dummy one.

How long will I be in the study?

The study participation for each person will last for about 13 weeks.

How to find out more

Nocion Clinical Trials

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study to Assess the Efficacy, Safety, and Tolerability of NO…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.