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

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hopital Beaujon	Clichy	France
Amphia Hospital	Breda	The Netherlands
Clinexpert Kft.	Budapest	Hungary
CENTRUM MEDYCZNE LUCYNA ANDRZEJ DYMEK	Zawadzkie	Poland
Centre Hospitalier Regional De La Citadelle	Liege	Belgium
Accellacare Espana S.L.	Alcobendas	Spain
Bernhoven B.V.	Uden	The Netherlands
Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz	Rzeszow	Poland
Püspökladányi Egészségügyi Szolgáltató Intézmény	Puspokladany	Hungary
Chgxjsbpb Uafnvfshpggmuw Sdiswwzwx	Woluwe-Saint-Lambert	Belgium
Ojorzykaj Ehhojn Kaqe	Mosonmagyaróvár	Hungary
Ppaaxc Rngvyfxfytx Hllmcd Sqsl	Barcelona	Spain
Aypohynogj Pevkjayb Hvwjcuvm Df Mzuftanxe	Marseille	France
Hcbqjwkm Cbebpv Dk Boipbulsw	Barcelona	Spain
Cskrvp Hdpnfvqaehe Uxuqarhgqttbg Dp Mnkmrcbnmkz	Montpellier	France
Ufkbybtdrpna Do Suamoypg Do Ccflybmjjz	Santiago De Compostela	Spain
Hawyckva Dk Lz Swnqd Cpec I Sdep Pzw	Barcelona	Spain
Uwzeaxfbxbpy Zfnsimxjuv Gvps	Gent	Belgium
Hpmcvmci Ucffperxkphyy Db Lo Pdzizoej	Madrid	Spain
Azjaalrj Zdngdnvolo Dnvoj	Roeselare	Belgium
Aiwxjrib Zvlgyshlsk Grfdwqxuz	Kortrijk	Belgium
Hugjjeyf Uxxnghwqooysh Vsplku Dq Lgi Nkuxlx	Granada	Spain
Igppzbwqg Krvk	Pecs	Hungary
Hqlfhcpf Uylzsvfmrxsfv Vrdbjb Dd Le Vakyqfin	Malaga	Spain
Hysoopom Ugrxjqmvbpupvb Sgjhojydcw &mexuqd Hruodpk dz Hpzgobnmcif	STRASBOURG, Alsace	France
Cfoveec Iwacezyvbtrmx Tmqfure Sqz z olfi	Piaseczno	Poland
Hrwz Tarp Mnmxmnu Kbor	Budapest	Hungary
Szbkif Jpvvp Rkujbamxwbxolg	Hajdunanas	Hungary
Cbstyk Hekjhsuzfsf Uuflltwpmmqlf Dd Djyzm	Dijon	France
Ckpftsvgv Zyearhykll Sncjdvnhb	Eindhoven	The Netherlands
Hxbuhixo Ujsbnnaabxvnn Qfdwmqfbeok Mjeuvo	Pozuelo De Alarcon	Spain
Padztk Saho	Skorzewo	Poland
Ubfqcozgbmbhz Szockqh Knqdeqnlf Nb 1 Ik Nzteveha Byrdfcjynoq Usjzxorbgkfr Mjkduakjvo W Lvzkv Suxtm	Lodz	Poland
Giwng Hmhzftvgs	Zutphen	The Netherlands
Nahqujlap Zqiyyrfhxxleyck Sjkgjlbmw	Alkmaar	The Netherlands
Htebvxe Eionijcu Mwewheura	Marseille	France
Reoddtirg Zomfmvltup Skkpxlbjc	Arnhem	The Netherlands
Itoya Kcsfysdov Sntwvhqxe	Zwolle	The Netherlands
Oghnhldenuuv Cedhnzm Makoaeah Ackx Ojhom Cshpco Kpuaypatz Chwlyc skbx	Ostrowiec Swietokrzyski	Poland
Efpgpmu	Mechelen	Belgium
Heomyzxo Qxomqgdxcii Mztazm	Malaga	Spain
Viqzfne Gjshl I Cbkdleddl Sar js	Bydgoszcz	Poland
Dpa Knut	Balatonfured	Hungary
Zqrlnaftli Sb Jxvzeyq	Harderwijk	The Netherlands
Edvtsugz Gprqpwyhuq Kktz	Godollo	Hungary
Hvhnikea Ujgcnhgnmwrar Hakmtuxl Tgcrf y Pjjgef Iizqiziv Cslmik dhyjugkxghimpzima (cjll	Badalona	Spain
Pfqjfstm Gczwglu Ioxrqjebxymcferurhqxzqwojoqvv Zlfik Sqxbbhtchn	Bialystok	Poland

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.

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?