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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Ayxvxyx Ugpee Sssfpuidl Loyskf Dd Bmstxpm	Bologna	Italy
Funcacpov Plbp Lz Iflzommfxlofi Bduthqflo Dra Hpflpyna Umwxppozonwwu Lb Pkd	Madrid	Spain
Hhwnlejz Vonn dekrexca	Barcelona	Spain
Hwfroxxd Uqjbnhlsgxcjt dt A Cdqrmb	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	30.01.2025
Spain	Recruiting	30.01.2025

Trial locations

Investigated drugs:

ENSIFENTRINE

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.

Investigated diseases:

Bronchiectasis

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 ID:

2024-514845-12-00

Protocol code:

RPL554-NCFB-220

NCT ID:

NCT06559150

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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