Cough Suppressive Therapy in Patients With Chronic Cough

NCT05522699 | Unknown

• 1 other identifier: 974599
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Cough

Outcome Measures

Primary Outcomes (1)

• Change in Leicester Cough Questionnaire (LCQ)

  Leicester Cough Questionnaire (LCQ) is an English-born self-reporting quality of life measure of chronic cough,

  Change from baseline LCQ at one week and 6 months after completed intervention

Secondary Outcomes (6)

• Change in The Work Ability Index (WAI)

  Change from baseline WAI at one week and 6 months after completed intervention

• Change in Cough frequency

  Change from baseline cough frequency at one week and 6 months after completed intervention

• Change in the hypersensitivity of the cough reflex

  Change from baseline hypersensitivity of the cough reflex at one week after completed intervention

• Change in inflammation biomarkers in blood; eosinophil count

  Change from baseline inflammation biomarkers (eosinophil count) in blood at one week after completed intervention

• Change in inflammation biomarker fractional exhaled nitric oxide (FeNO)

  Change from baseline FeNo at one week after completed intervention

Study Arms (2)

Cough suppressive therapy

EXPERIMENTAL

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.

Behavioral: Cough suppressive therapy

Healthy lifestyle instructions

ACTIVE COMPARATOR

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.

Behavioral: General healthy lifestyle instructions

Interventions

Cough suppressive therapy BEHAVIORAL

The cough suppressive therapy based on the treatment regime "Physiotherapy, and speech and language therapy intervention for patients with refractory chronic cough (PSALTI) developed by S. Chamberlain et al (Thorax. 2017 Feb;72(2):129-136).

Cough suppressive therapy

General healthy lifestyle instructions BEHAVIORAL

The general healthy lifestyle instructions are based on the recommendations from the The Public Health Agency of Sweden.

Healthy lifestyle instructions

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala Academical Hopsital

Uppsala, 75185, Sweden

RECRUITING

MeSH Terms

Conditions

Chronic Cough

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Helen Wallstedt

  Uppsala Academical Hospital, Uppsala, Sweden

  STUDY DIRECTOR

Central Study Contacts

Principal investigator, Phd

CONTACT

+46186110000; lungforskning@akademiska.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 31, 2022
• Study Start: November 3, 2022
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)