- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03457610
Speech Therapy in the Management of Chronic Cough
Speech Therapy in the Management of Difficult-to-treat Chronic Cough
Speech and language intervention (speech therapy) is one of the few methods which seem to be useful in management of persistent chronic cough. This method has not been available for patients with cough in Poland so far.The aim of the study is to implement speech therapy to the management plan of patients with difficult-to-treat chronic cough and to analyze its efficacy in this particular group.
Patients with difficult-to treat chronic cough will be offered speech and language intervention as an added therapy. The effectiveness of speech therapy will be measured by changes in cough severity, its influence on quality of life and cough challenge test before and after speech therapy measured in every patient.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The efficacy of management of chronic cough in adults is limited. Speech and language intervention (speech therapy) is one of the few methods which seem to be useful in management of persistent chronic cough. This method has not been available for patients with cough in Poland so far.
The aim of the study is to implement speech therapy to the management plan of patients with difficult-to-treat chronic cough and to analyze its efficacy in this particular group.
Patients, who are diagnosed and unsuccessfully managed because of difficult-to treat chronic cough, will be offered speech and language intervention as an added therapy. It is based on the technique described by Vertigan et al.The entire therapy will consist of eight sessions once a week.
Cough severity, its influence on quality of life and cough challenge test with capsaicin will be assessed by Visual Analogue Scale, Leicester Cough Questionnaire and cough challenge test with capsaicin will be performed before and after speech therapy in every patient to analyze its effectiveness
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Warsaw, Poland, 02-097
- Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age between 18 and 80 years,
- chronic cough lasting more than six months
- earlier thorough diagnosing of cough reason
- unsuccessful cough management despite at least 3 months of earlier treatment
- no symptoms of any airway infection during last 4 weeks.
Exclusion Criteria:
- lack of opportunity to participate in speech therapy sessions
- cough lasting less than 6 months
- active cigarette smoking
- taking ACE inhibitors
- symptoms of airway infection (other than cough).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Speech and language intervention
|
Speech therapy includes education about cough and vocal hygiene, teaching strategies to reduce cough, breathing and vocal exercises.
The whole therapy consists of eight sessions once a week.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cough severity
Time Frame: 3 months
|
measured by Visual Analogue Scale (VAS), range 0-100 mm, the more severe cough , the higher value in VAS score
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cough related quality of life
Time Frame: 3 months
|
measured by Leicester Cough Questionnaire (LCQ)- health related Quality of Life Questionnaire dedicaated for patients, who cough; rangeof total LCQ is 3 to 21 points; higher values represent less intense cough
|
3 months
|
Sensitivity of cough reflex
Time Frame: 3 months
|
measured by cough challenge test with capsaicin
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3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Morice AH, Fontana GA, Belvisi MG, Birring SS, Chung KF, Dicpinigaitis PV, Kastelik JA, McGarvey LP, Smith JA, Tatar M, Widdicombe J; European Respiratory Society (ERS). ERS guidelines on the assessment of cough. Eur Respir J. 2007 Jun;29(6):1256-76. doi: 10.1183/09031936.00101006. No abstract available.
- Vertigan AE, Theodoros DG, Gibson PG, Winkworth AL. Efficacy of speech pathology management for chronic cough: a randomised placebo controlled trial of treatment efficacy. Thorax. 2006 Dec;61(12):1065-9. doi: 10.1136/thx.2006.064337. Epub 2006 Jul 14.
- Gibson P, Wang G, McGarvey L, Vertigan AE, Altman KW, Birring SS; CHEST Expert Cough Panel. Treatment of Unexplained Chronic Cough: CHEST Guideline and Expert Panel Report. Chest. 2016 Jan;149(1):27-44. doi: 10.1378/chest.15-1496. Epub 2016 Jan 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pulm2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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