Cough Suppressive Therapy in Patients With Chronic Cough

Status Recruiting

Clinical Trial Summary

In this randomized, placebo-controlled, interventional study on chronic cough a non-pharmacological cough suppressive therapy is the intervention to be studied, with a control group receiving treatment consisting of general healthy lifestyle advice. The following data will be collected before, after and up to six months after treatment: Standardized questionnaires for diagnosis of background factors, Leicester Cough Questionnaire (LCQ), Work Ability Index (WAI), and cough frequency as well as lung function and biomarkers. The primary treatment effect measurement will be changes in chronic cough-related quality of life, measured by the Leicester Cough Questionnaire (LCQ).

Clinical Trial Description

The study will be carried out in collaboration between respiratory physicians, clinical physiologists, physiotherapists, speech- and language therapists and gastroenterologists. The primary hypothesis of the planned study is: The cough suppressive therapy improves chronic cough-related quality of life and work ability, and is sustained over six months after treatment. The secondary hypotheses of the planned study are: Treatment of chronic cough by the cough suppressive therapy can reduce cough frequency (measured by an automated cough detector), airway inflammation and airway resistance. Baseline differences in clinical findings, biomarkers and physiologic measurements predict different treatment effects. The following data will be collected before and after treatment: - Standardized questionnaires for diagnosis of background factors and cough duration, LCQ, WAI, questions on sick leave days, voice disturbance questionnaire. - Physiological measurements: Spirometry with reversibility test, impulse oscillometry before and after provocation with hypertonic saline inhalation. 24 hours cough frequency analysis, voice analysis. - Biomarkers: Fractional exhaled nitric oxide (FeNO), blood-eosinophils and eosinophil cationic protein in serum, proteomics in particles in exhaled air (PExA) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05522699
Study type	Interventional
Source	Uppsala University
Contact	Principal investigator, Phd
Phone	+46186110000
Email	lungforskning@akademiska.se
Status	Recruiting
Phase	N/A
Start date	November 3, 2022
Completion date	December 31, 2024

View Details

See also
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Terminated	`NCT03864328` - A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF	Phase 2
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.