#1 Clinical Trials Search in Europe

Study on the Effectiveness and Safety of Camlipixant for Adults with Refractory or Unexplained Chronic Cough

3 1

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. The trial will evaluate a new treatment called BLU-5937, which contains the active substance Camlipixant. Participants in the study will receive either BLU-5937 or a placebo, which is a substance with no active medication, to compare the effects on cough frequency and safety.

The purpose of the study is to assess how effective BLU-5937 is in reducing the frequency of coughing over a 24-hour period in adults with this chronic cough condition. The study will also monitor the safety of BLU-5937 over a period of 24 weeks. Participants will be randomly assigned to receive either the medication or a placebo, and neither the participants nor the researchers will know who is receiving which treatment during the study period. This is known as a double-blind study, which helps ensure unbiased results.

The study will last for 24 weeks, with an additional open-label extension phase where all participants may receive BLU-5937. During the study, participants will have regular check-ups to monitor their health and any changes in their cough frequency. The study aims to provide valuable information on the potential benefits and safety of BLU-5937 for people suffering from refractory or unexplained chronic cough.

1 joining the study

Upon joining the study, participants are required to provide informed consent, confirming their understanding of the study’s purpose and procedures.

Eligibility is confirmed based on criteria such as age (18-80 years), diagnosis of refractory chronic cough for at least one year, and specific cough frequency requirements.

2 randomization and initial assessment

Participants are randomly assigned to receive either the study medication, BLU-5937, or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the medication or placebo.

Initial assessments include baseline measurements of cough frequency and other health indicators.

3 medication administration

Participants take the assigned tablets orally. The tablets are oval, biconvex, and white to off-white in color.

The study medication, BLU-5937, is administered over a 24-week period. The exact dosage and frequency are determined by the study protocol.

4 monitoring and assessments

Throughout the 24-week period, participants undergo regular monitoring to assess cough frequency and any changes in health status.

Assessments include measuring 24-hour cough frequency, vital signs, and laboratory values. Participants may also complete questionnaires about their symptoms and quality of life.

5 completion of the double-blind phase

At the end of the 24-week period, participants complete the double-blind phase of the study.

Final assessments are conducted to evaluate the primary and secondary endpoints, such as changes in cough frequency and any adverse effects experienced.

6 open-label extension

Participants may have the option to continue in an open-label extension phase, where all participants receive BLU-5937.

This phase allows for further evaluation of the medication’s long-term safety and effectiveness.

Who Can Join the Study?

  • Must be between 18 and 80 years old.
  • Must be able to understand and agree to the written informed consent, which is a document explaining the study and what participation involves.
  • Must have been diagnosed with Refractory Chronic Cough (a persistent cough that doesn’t respond to treatment) or Unexplained Chronic Cough (a persistent cough with no known cause) for at least 1 year before the screening.
  • Must meet the specific criteria for how often they cough.
  • If female, must not be pregnant or breastfeeding. She must either not be able to become pregnant or agree to use birth control as advised.

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. This means if your cough is due to another illness, you cannot participate.
  • Patients who are currently taking medications that might affect the study results. This means if you are on certain drugs that could change how the study works, you cannot join.
  • Patients with a history of significant lung diseases, such as asthma or chronic obstructive pulmonary disease (COPD). These are conditions that affect your breathing and lungs.
  • Patients who have had recent surgery or are planning to have surgery during the study period. Surgery can affect your health and the study results.
  • Patients who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
  • Patients who have participated in another clinical trial within the last 30 days. This is to avoid any interference with the current study.
  • Patients with a history of drug or alcohol abuse. This is to ensure that participants are in a stable condition to take part in the study.
  • Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate. This means if there is any other health issue that could be risky, you cannot join.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Alergo Med Osrodek Badan Klinicznych Sp. z o.o. Tarnow Poland
Pneumologisches Forschungsinstitut Hohegeest GbR Geesthacht Germany
Klinische Forschung Karlsruhe GmbH Karlsruhe Germany
Pneumologisches Studienzentrum München-West Munich Germany

Other Sites

Site Name City Country Status
Klinische Forschung Hannover-Mitte GmbH Hanover Germany
Klinische Forschung Berlin-Mitte GmbH Berlin Germany
Klinische Forschung Hamburg GmbH Hamburg Germany
Alian s.r.o. Bardejov Slovakia
Medizentrum Essen Borbeck Essen Germany
Zentrum Fuer Ambulante Pneumologische Forschung Marburg GbR Marburg Germany
Pneumo Studien Darmstadt GmbH Darmstadt Germany
IKF Pneumologie GmbH & Co. KG Frankfurt Germany
MUDr. Ilona Pavlisova s.r.o. Miroslav Czechia
Siteworks GmbH Hanover Germany
Velocity Clinical Research Luebeck GmbH Luebeck Germany
Medaimun GmbH Frankfurt Germany
Fakultni Nemocnice Brno Brno Czechia
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
University Hospital Olomouc Olomouc Czechia
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Lungenzentrum Maingau Frankfurt Germany
MUDr. I. Cierna Peterova s.r.o. Brandys Nad Labem Czechia
Pneumologicum im Suedstadtforum Dr. Alexander Schulz Dr. Martin Hoffmann Dr. Henning Geldmacher PD Dr. Hendrik Suhling Fachaerzte fuer Innere Medizin Pneumologie Partnerschaftsgesellschaft Hanover Germany
D A W O N spol. s r.o. Prague Czechia
MUDr. Jaroslav Mareš – TBC a respir. nemoci Strakonice Czechia
Centrum Zdrowia MDM Warsaw Poland
Ihvsbvt sqwgcd Humenne Slovakia
Kwejiukup Fwmxwctmy Dcalffb Ggbt Dresden Germany
Zaezvwkioc zcslfjojzgskc Khikvh seqzoj Kosice Slovakia
Assjzjjkfch cwgolzl smewyf Kezmarok Slovakia
Pfsocsozbs soeery Prievidza Slovakia
Pmwqfozuqlyvguq Sxxklshfoksfwv Mvj dkzawzmqqnhraor Berlin Germany
Btmevqorseidx Fxywjldm Wrhjhnh Neu-Isenburg Germany
Cmioytd Ihxwrwyngcljg Tblrziv Sdm z ojws Piaseczno Poland
Pkpfuxks agxaebfehq Hhganexn scugqo Spisska Nova Ves Slovakia
Niz Sru Jpjhlr Bwyzwulh nkht Bardejov Slovakia
Pznhsuwcxyae Mdjqllupkf Pktlfmtj Ggpjepi Lgblhfqr Rzeszow Poland
Plutnpgggtrjc Hbkvo Halle (Saale) Germany
Sleyyyallhtxzq Dth mtwy Sjdefzvht Peine Germany
Gqmbty Ufecterfhv Fxvgdqjzn Frankfurt Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
12.04.2023
Germany Germany
Not recruiting
12.04.2023
Poland Poland
Not yet recruiting
12.04.2023
Slovakia Slovakia
Not recruiting
12.04.2023

Trial locations

Investigated drugs:

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. This trial aims to see how effective and safe BLU-5937 is over a period of 24 weeks. Participants in the study will receive this medication to determine if it can help manage their chronic cough symptoms.

Refractory Chronic Cough – This condition is characterized by a persistent cough that does not respond to standard treatments. It often lasts for more than eight weeks and can significantly impact a person’s quality of life. The cough may be dry or produce mucus and can occur at any time of the day or night. The exact cause of refractory chronic cough is often unknown, making it challenging to manage. It may be associated with other conditions such as asthma, gastroesophageal reflux disease, or postnasal drip. The cough can be triggered by irritants like smoke, dust, or strong odors.

Trial ID:
2024-513462-19-00
Protocol code:
BUS-P3-02
NCT ID:
NCT05600777
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on the Effectiveness of Fluticasone Propionate and Amoxicillin-Clavulanic Acid for Children with Long-Lasting Cough

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Finland

  • Study on the Effectiveness of Amoxicillin and Clavulanic Acid in Treating Chronic Wet Cough in Young Children

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Norway