Cough – Trials in Disease

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Ongoing Clinical Trials for Chronic Cough

There are currently 5 ongoing clinical trials investigating new treatments for chronic cough. These studies are testing medications to reduce cough frequency in adults and children with persistent coughing that doesn’t respond to standard treatments or has no clear cause.

Clinical trial locations

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

This study is testing a new medication called BLU-5937, which contains camlipixant, for adults who have a persistent cough that hasn’t responded to standard treatments or has no clear cause. The study focuses on refractory chronic cough, a condition where the cough lasts for a long time and doesn’t get better with usual treatments.

Who can participate: Adults between 18 and 80 years old who have had refractory or unexplained chronic cough for at least one year are eligible. Participants must meet specific requirements for how often they cough. Women who are pregnant or breastfeeding cannot join, and those who can become pregnant must use proper birth control methods.

Who cannot participate: People whose cough is caused by a known medical condition other than refractory or unexplained chronic cough are excluded. Those currently taking certain medications that might affect study results, people with significant lung diseases like asthma or chronic obstructive pulmonary disease, and those who have recently had surgery or are planning surgery are also excluded. People with a history of drug or alcohol abuse and those who participated in another clinical trial within the last 30 days cannot join.

What the study involves: The trial will run for 24 weeks and compare BLU-5937 to a placebo. Participants will be randomly assigned to receive either the medication or placebo as an oral tablet. Neither participants nor researchers will know who receives which treatment during the study. The main goal is to measure how much the medication reduces cough frequency over a 24-hour period. There is also an optional open-label extension phase where all participants may receive BLU-5937.

The investigational drug: BLU-5937 works by blocking specific receptors in the body involved in the cough reflex. It is classified as a selective P2X3 receptor antagonist and is currently in Phase 3 clinical trials.

Study on the Effectiveness and Safety of Taplucainium Inhalation Powder (NOC-110) for Adults with Refractory or Unexplained Chronic Cough

This trial is evaluating taplucainium inhalation powder for adults with persistent cough that doesn’t respond to usual treatments or has no identifiable cause. The medication is taken by breathing in a powder through a special inhaler device called a Monodose Dry Powder Inhaler.

Who can participate: Adults who have had refractory or unexplained chronic cough for at least 12 months can participate. Women who can have children must agree to use specific birth control methods during the study, and men who have not had a vasectomy must also use birth control. All participants must be able to provide informed consent.

Who cannot participate: People whose chronic cough is not refractory or unexplained are excluded, as well as those outside the specified age range. People who belong to vulnerable populations, such as children or pregnant women, cannot participate.

What the study involves: The study lasts 28 days, during which participants take the medication once daily. Participants will be randomly assigned to receive either taplucainium at one of three dose levels (1 mg, 3 mg, or 6 mg) or a placebo. The trial is double-blind, so neither participants nor researchers know who receives which treatment. Researchers will monitor how often participants cough over 24 hours using a device called VitaloJAK and will assess changes in cough severity and urge to cough using questionnaires.

The investigational drug: Taplucainium inhalation powder works directly in the lungs by targeting specific pathways involved in the cough reflex. It is classified as a respiratory medication and is being studied to see if it can help calm the urge to cough.

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

This study focuses on young children who have a persistent cough that produces mucus. The trial is testing whether Augmentin, a combination of amoxicillin and clavulanic acid, can effectively treat chronic wet cough in children.

Who can participate: Children between 9 and 36 months old who were born at full term and weigh between 7 kg and 24 kg can join. The child must have a chronic wet cough lasting more than 4 weeks, with an average cough score of 4 or more over the last 7 days. Both parents must provide written consent for their child to participate.

Who cannot participate: Children without a chronic wet cough, those outside the specified age range, children with other medical conditions that might interfere with the study, and those currently taking medications that could affect results are excluded. Children with allergies to amoxicillin-clavulanate, those who recently participated in another clinical trial, and those with a history of severe reactions to antibiotics cannot join. Children unable to follow study procedures are also excluded.

What the study involves: Participants will receive either Augmentin or a placebo as an oral suspension with a mixed fruit flavor for either 14 or 28 days. The study aims to see if children taking the antibiotic show greater improvement compared to those taking placebo. Parents will report their child’s cough score daily. The study also explores whether bacteria in the airways and gut, inflammation markers, and genetics might influence the cough and its treatment.

The investigational drug: Amoxicillin-clavulanate is a combination antibiotic where amoxicillin fights bacteria by interfering with their cell wall formation, while clavulanate prevents certain bacteria from becoming resistant to amoxicillin. It is classified as a penicillin-type antibiotic combined with a beta-lactamase inhibitor.

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

This trial evaluates two different treatments for children with protracted cough, which is a cough that lasts for an extended period without any underlying health issues. The study compares an inhaled corticosteroid called fluticasone propionate and an oral antibiotic called amoxicillin-clavulanic acid against a placebo.

Who can participate: Children with a protracted cough lasting more than 4 weeks every day can join. The child must not have a previous doctor’s diagnosis that could explain the long-lasting cough and must not show symptoms suggesting another underlying condition. Children must not have had allergic reactions or serious side effects to the study medications. Parents must be able to speak and write in Finnish and provide written consent.

Who cannot participate: Children who are not in the age range specified for the study and those who belong to vulnerable populations are excluded. Children currently participating in another medical study cannot join.

What the study involves: Participants are randomly assigned to receive either the inhaled corticosteroid, the oral antibiotic, or a placebo. The study is double-blinded, meaning neither participants nor researchers know who receives which treatment. Children with a prolonged dry cough receive fluticasone propionate through an inhaler at 125 micrograms per dose for up to eight weeks. Those with a prolonged wet cough receive amoxicillin-clavulanic acid by mouth for up to two weeks. The goal is to observe a significant reduction in cough, defined as complete cessation or at least 75% reduction in symptom scores over three consecutive days.

The investigational drugs: Fluticasone propionate is an inhaled corticosteroid that reduces inflammation in the airways by binding to glucocorticoid receptors. Amoxicillin-clavulanic acid is a penicillin-type antibiotic that kills bacteria by disrupting their cell wall formation, while clavulanic acid prevents bacterial resistance.

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

This study investigates BLU-5937, containing camlipixant, for adults with refractory or unexplained chronic cough. The trial is designed to assess both the effectiveness and safety of this medication over a longer period compared to the previous camlipixant study.

Who can participate: Adults between 18 and 80 years old who have been diagnosed with refractory chronic cough for at least one year before the study starts are eligible. Participants must meet specific criteria for cough frequency. Women must not be pregnant or breastfeeding, and those who can have children must agree to use birth control.

Who cannot participate: People whose cough is caused by a known medical condition other than refractory or unexplained chronic cough are excluded. Those currently participating in another clinical trial, people with a history of drug or alcohol abuse, and those with certain medical conditions that could interfere with the study cannot join. Pregnant or breastfeeding women, people who recently had a respiratory infection, and those unable to comply with study procedures are also excluded.

What the study involves: This trial lasts 52 weeks, with participants randomly assigned to receive either BLU-5937 or placebo as an oral tablet. The study is double-blind. Cough frequency is measured over 24 hours using a cough monitor at baseline and at regular intervals, including Week 12. After the initial period, participants may enter an optional open-label extension where everyone receives BLU-5937, allowing for continued monitoring of long-term effects and safety.

The investigational drug: BLU-5937 is a P2X3 receptor antagonist that selectively blocks receptors involved in the cough reflex pathway. It is currently in Phase 3 clinical trials evaluating its efficacy and safety over an extended period.

Summary

The five ongoing clinical trials for chronic cough reflect diverse approaches to treating this condition across different age groups. Three of the trials focus on adults with refractory or unexplained chronic cough, with two testing camlipixant (BLU-5937) and one testing taplucainium inhalation powder. The remaining two studies focus on children, evaluating antibiotics and corticosteroids for various types of persistent cough.

Geographically, most trials are concentrated in European countries. Germany and Belgium appear in multiple studies, while Poland, France, Spain, Hungary, Netherlands, Slovakia, and Czechia also host adult trials. Studies in children are located in Norway and Finland. This distribution suggests strong European involvement in chronic cough research.

A notable pattern is the focus on P2X3 receptor antagonists for adult refractory cough, with two separate trials testing camlipixant at different durations. For children, the approach differs, with studies testing traditional medications like antibiotics and corticosteroids rather than newer targeted therapies. The trials vary in length from 28 days to 52 weeks, reflecting different research objectives and treatment approaches.

Ongoing Clinical Trials on Cough

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

    Recruiting

    3 1 1
    Investigated diseases:
    Finland
  • Study on the Effectiveness of Amoxicillin and Clavulanic Acid in Treating Chronic Wet Cough in Young Children

    Recruiting

    3 1 1
    Investigated diseases:
    Norway
  • Study on the Effects of Camlipixant in Adults with Refractory or Unexplained Chronic Cough

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Hungary The Netherlands Poland Spain