Cough Suppressive Therapy in Patients With Chronic Cough

Uppsala University

Status: Enrolling

Conditions: Chronic Cough

Treatments: Behavioral: General healthy lifestyle instructions; Behavioral: Cough suppressive therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05522699

974599

Details and patient eligibility

About

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).

Full 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)

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic cough (duration >2 months) without a structural lung disease and a normal chest X-ray, which have failed pharmacological treatment.
• Being able to understand the swedish language.

Exclusion criteria

• Pulmonary abnormalities on a chest X-ray, structural lung disease, or chronic obstructive pulmonary disease (COPD) of spirometry stage Global Initiative for Obstructive Lung Disease (GOLD) 2 or higher.
• Smoking under the last three months.
• Ongoing or recent treatment with angiotensin-converting enzyme (ACE) inhibitor
• Active aspiration, vocal cord nodules or upper respiratory tract infection in the previous 4 weeks.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Cough suppressive therapy

Experimental group

Description:

The cough suppressive therapy consists of four one-to-one treatment sessions, 45 minutes per session, over a 2 months period. The sessions include patient education about chronic cough; negative effects of repeated cough as well as patient education of voluntary control of cough; identification of cough triggers and learning cough suppression techniques, and psychoeducational counselling including patient self-motivation, repetition of aims and techniques, behavior modification regarding over-awareness of the need to cough. The sessions will be conducted by a specially trained physiotherapist or speech and language therapist. All components of the cough suppressive therapy will be delivered to each participant but the focus and emphasis on individual techniques will be individually tailored for each participant, determined by the physio- or speech and language therapist together with the participant.

Treatment:

Behavioral: Cough suppressive therapy

Healthy lifestyle instructions

Active Comparator group

Description:

The Healthy lifestyle instructions consists of four one-to-one treatment sessions, 30 minutes per session, over a 2 months period. The sessions will be conducted by a specially trained physiotherapist or speech and language therapist. The sessions include patient education and motivational conversation about healthy eating habits, physical activity, stress and relaxation.

Treatment:

Behavioral: General healthy lifestyle instructions