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Study on the Effects of Ensifentrine for Patients with Non-Cystic Fibrosis Bronchiectasis

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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 a lung condition called Non-Cystic Fibrosis Bronchiectasis. This condition involves damage to the airways, leading to symptoms like a persistent cough and frequent lung infections. The study will test a treatment called Ensifentrine, which is an inhalation suspension. Ensifentrine is designed to help improve breathing and reduce lung flare-ups. The study will compare the effects of Ensifentrine to a placebo, which looks like the treatment but does not contain the active ingredient.

The purpose of the study is to evaluate how well Ensifentrine works in reducing lung flare-ups in people with Non-Cystic Fibrosis Bronchiectasis. Participants will be randomly assigned to receive either Ensifentrine or a placebo. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual treatment or the placebo, ensuring unbiased results. The treatment will be administered twice a day using a nebulizer, a device that turns liquid medicine into a mist for inhalation.

Throughout the study, participants will attend regular visits to monitor their health and the effects of the treatment. The study will last for several months, during which the frequency of lung flare-ups and other health indicators will be closely observed. This research aims to provide valuable information on the potential benefits of Ensifentrine for individuals with Non-Cystic Fibrosis Bronchiectasis.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, the participant will begin by providing informed consent, indicating an understanding of the study's purpose and procedures.

    Eligibility is confirmed based on age, clinical history, and ability to perform necessary procedures such as using a nebulizer and providing sputum samples.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm the participant's medical condition, specifically non-cystic fibrosis bronchiectasis.

    This may involve reviewing past medical records or conducting a chest CT scan if previous records are unavailable.

  3. Step 3

    Medication administration

    Participants will receive either ensifentrine inhalation suspension or a placebo. The placebo is similar to the ensifentrine suspension but does not contain the active ingredient.

    The medication is administered via inhalation using a nebulizer, twice daily (BID), with each dose containing 3 mg of ensifentrine.

  4. Step 4

    Ongoing monitoring

    Participants will be monitored for the occurrence of pulmonary exacerbations, which are episodes of worsening respiratory symptoms.

    Regular assessments will be conducted to evaluate changes in symptoms and lung function over time.

  5. Step 5

    Study duration

    The study is expected to continue until February 2027, with participants attending all scheduled visits and adhering to study procedures throughout this period.

Who can join the trial?

11 criteria

  • Must be able to give informed consent, which means understanding the study's purpose and agreeing to follow the study's rules.
  • Must be willing and able to attend all study visits and follow all study procedures.
  • Must be between 18 and 85 years old.
  • Men must agree to use birth control during the study and for at least 30 days after the last dose of the study medication.
  • Women must not be pregnant or breastfeeding. If they can have children, they must agree to use birth control during the study and for at least 30 days after the last dose of the study medication.
  • Must have a history of **bronchiectasis**, which is a lung condition that causes coughing, long-term mucus production, or repeated lung infections. This must be confirmed by a chest CT scan, which is a special type of X-ray.
  • Must currently produce sputum, which is mucus from the lungs, and be able to provide a sample during the screening.
  • The sputum must be of a certain color, either **mucopurulent** (cloudy) or **purulent** (pus-like), as checked by a color chart.
  • Must have had at least one **pulmonary exacerbation**, which is a worsening of lung symptoms that required antibiotics, in the past year.
  • Must be able to use the study nebulizer, a device that turns liquid medicine into a mist to be inhaled.
  • Must be able to perform **spirometry**, a test that measures lung function, according to specific guidelines.

Who cannot join the trial?

8 criteria

  • Patients with a history of **Non-Cystic Fibrosis Bronchiectasis** cannot participate. This is a lung condition where the airways become widened and scarred, leading to mucus build-up and infections.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to use a **nebulizer** cannot participate. A nebulizer is a device that turns liquid medicine into a mist to be inhaled into the lungs.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a recent lung infection or **pulmonary exacerbation** cannot participate. A pulmonary exacerbation is a worsening of lung symptoms, like increased coughing or difficulty breathing.
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Investigated drugs

Ensifentrine: This medication is being studied for its potential to help people with a lung condition called non-cystic fibrosis bronchiectasis. It is administered through a nebulizer, which turns the medication into a mist that can be inhaled directly into the lungs. The goal of using ensifentrine in this study is to see if it can reduce the number of times patients experience worsening of their lung symptoms, known as pulmonary exacerbations.

What is already known about the treatment

Ensifentrine – Ensifentrine is administered through inhalation using a nebulizer, typically twice a day. It is currently being studied in clinical trials, specifically for its effects on non-cystic fibrosis bronchiectasis. The main therapeutic indication for ensifentrine is to reduce pulmonary exacerbations in patients with this condition. At the molecular level, ensifentrine works by inhibiting enzymes that break down certain signaling molecules, leading to bronchodilation and reduced inflammation in the airways. It is classified pharmacologically as a dual inhibitor of phosphodiesterase 3 and 4.

Investigated diseases

Non-Cystic Fibrosis Bronchiectasis – This is a chronic lung condition where the airways become widened and scarred, leading to a build-up of mucus. This can cause frequent lung infections and persistent coughing. Over time, the airways can become more damaged, making it harder to clear mucus and breathe properly. Symptoms often include a chronic cough, production of sputum, and shortness of breath. The condition can lead to repeated lung infections, which may worsen the symptoms. It is not related to cystic fibrosis, although it shares some similar features.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514845-12-00Protocol codeRPL554-NCFB-220Estimated enrolment203 patients

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