Study on the Effects of Camlipixant in Adults with Refractory or Unexplained Chronic Cough

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What is this study about?

This clinical trial is focused on studying a condition known as Refractory Chronic Cough, which includes cases of Unexplained Chronic Cough. This condition is characterized by a persistent cough that does not respond to standard treatments and has no identifiable cause. The trial will evaluate a new treatment called BLU-5937, which contains the active substance Camlipixant. This medication is taken in the form of a tablet.

The purpose of the study is to assess the effectiveness and safety of BLU-5937 compared to a placebo in reducing the frequency of coughing over a 24-hour period. Participants in the study will be randomly assigned to receive either the medication or a placebo. The study will last for 52 weeks, with an option for participants to continue in an open-label extension, where all participants can receive BLU-5937 if they choose.

Throughout the study, participants will be monitored to ensure their safety and to track any changes in their cough frequency. The study aims to provide valuable information on how well BLU-5937 works in managing chronic cough and its safety profile over the course of the treatment period.

1 randomization and initial assessment

Upon joining the study, participants are randomly assigned to receive either the study medication, BLU-5937, or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

An initial assessment is conducted to establish baseline cough frequency over a 24-hour period using a cough monitor.

2 medication administration

Participants take the assigned medication orally in the form of a tablet. The tablets are round, biconvex, and white to off-white in color.

The medication is taken as prescribed by the study protocol, with specific dosage and frequency determined by the study design.

3 monitoring and follow-up

Participants are monitored regularly to assess the effect of the medication on cough frequency. This includes periodic evaluations at specified intervals, such as at Week 12.

Safety assessments are conducted throughout the study to monitor for any adverse effects or serious adverse events.

4 open-label extension

After the initial 52-week period, participants may enter an open-label extension phase where all participants receive BLU-5937.

This phase allows for continued monitoring of the medication’s long-term effects and safety.

5 completion and final assessment

At the end of the study, a final assessment is conducted to evaluate the overall impact of the medication on cough frequency and participant safety.

Participants are provided with information regarding the study’s findings and any relevant follow-up care.

Who Can Join the Study?

Must be between 18 and 80 years old.
Must be able to understand and agree to the written consent form.
Must have been diagnosed with Refractory Chronic Cough (a cough that doesn’t go away) for at least 1 year before the study starts.
Must meet the specific criteria for how often they cough.
If female, must not be pregnant or breastfeeding. Must either not be able to have children or agree to use birth control if they can have children.

Who Cannot Join the Study?

Patients who have a cough caused by a known medical condition other than Refractory Chronic Cough or Unexplained Chronic Cough cannot participate. Refractory Chronic Cough means a cough that does not get better with treatment.
Patients who are currently participating in another clinical trial are not eligible.
Patients who have a history of drug or alcohol abuse may be excluded.
Patients with certain medical conditions that could interfere with the study may not be allowed to join.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have had a recent respiratory infection may be excluded.
Patients who are unable to comply with the study procedures or follow-up visits may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Navarra	Pamplona	Spain
Alergo Med Osrodek Badan Klinicznych Sp. z o.o.	Tarnow	Poland
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Universitair Ziekenhuis Gent	Gent	Belgium
Isala Klinieken Stichting	Zwolle	The Netherlands
Centre Hospitalier Regional De La Citadelle	Liege	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Amphia Hospital	Breda	The Netherlands
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Vitamed Galaj I Cichomski Sp. j.	Bydgoszcz	Poland
DRC Kft.	Balatonfured	Hungary
Ziekenhuis St Jansdal	Harderwijk	The Netherlands
Hopital Europeen Marseille	Marseille	France
Bernhoven B.V.	Uden	The Netherlands
Erzsebet Gondozohaz Kft.	Godollo	Hungary
Hospital Quironsalud Malaga	Malaga	Spain
Accellacare Espana S.L.	Alcobendas	Spain
Clinexpert Kft.	Budapest	Hungary
Hospital Clinic De Barcelona	Barcelona	Spain
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Pratia S.A.	Skorzewo	Poland
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Gelre Hospitals	Zutphen	The Netherlands
Hopital Beaujon	Clichy	France
Infer-Med Kft.	Pecs	Hungary
High Tech Medical Kft.	Budapest	Hungary
Hospital Universitario Virgen De La Victoria	Malaga	Spain
CENTRUM MEDYCZNE LUCYNA ANDRZEJ DYMEK	Zawadzkie	Poland
Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz	Rzeszow	Poland
Prywatny Gabinet Internistyczno-Alergologiczny Zenon Siergiejko	Bialystok	Poland
Püspökladányi Egészségügyi Szolgáltató Intézmény	Puspokladany	Hungary
Cxtyrdout Udbgochabddhue Swgyfuesh	Woluwe-Saint-Lambert	Belgium
Rmmuqalxx Zsoczkkevc Sdigigduv	Arnhem	The Netherlands
Hmxqiwtd Ucredrusbwxwz Dq Lx Pzvonozu	Madrid	Spain
Odlvdkvkdgxn Cfepulh Memcqgek Auei Ofcph Ckouli Kcfycfyse Cifyyw sntz	Ostrowiec Swietokrzyski	Poland
Esoajhb	Mechelen	Belgium
Pologe Rsyrsqhmcob Hormxu Syet	Barcelona	Spain
Ozxaexyhm Evpnrr Kjhy	Mosonmagyaróvár	Hungary
Cjfsiir Isjmvtqtlijsg Txeltib Sja z oguj	Piaseczno	Poland
Swfviy Jxcdo Rluzoqrjwibeti	Hajdunanas	Hungary
Chsjuv Hwxsejofwsk Ugoouqaojepsl Du Dnlql	Dijon	France
Aovqtqajqy Pbxufviz Hcmkbgtp Dt Myajtmfnr	Marseille	France
Hyqpsujf Df Lu Skjht Ctth I Saxo Pyw	Barcelona	Spain
Hwkvjimk Uadcdaqarsugo Hvwmassi Tsval y Pqpmaa Icphhwag Cbxeqe dhslodqibmyanavnd (ugmd	Badalona	Spain
Hxkemycc Urqymejpqxepif Sepnzhyuos &pphpqx Hndoees dh Hjmiaqbzmeo	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	19.04.2023
France	Not recruiting	19.04.2023
Hungary	Not recruiting	19.04.2023
Poland	Not recruiting	19.04.2023
Spain	Not recruiting	19.04.2023
The Netherlands	Not recruiting	19.04.2023

Trial locations

Investigated drugs:

Camlipixant

BLU-5937 is a medication being studied for its potential to reduce the frequency of coughing in adults who have a persistent cough that does not have a clear cause or does not respond to usual treatments. The trial aims to see how well this medication works over a 24-hour period and to ensure it is safe for use over a longer term, up to 52 weeks.

Investigated diseases:

Cough

Refractory Chronic Cough – This condition is characterized by a persistent cough that lasts for more than eight weeks and does not respond to standard treatments. It can be caused by various underlying issues, but in some cases, the exact cause remains unknown, leading to a diagnosis of unexplained chronic cough. The cough can be disruptive to daily life, affecting sleep and social interactions. It often requires a comprehensive evaluation to rule out other potential causes. The condition can be frustrating for patients due to its persistent nature and the difficulty in finding effective relief.

Trial ID:

2024-513460-26-00

Protocol code:

BUS-P3-01

NCT ID:

NCT05599191

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Camlipixant in Adults with Refractory or Unexplained Chronic Cough

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?