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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03457610
Other study ID # Pulm2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date January 30, 2020

Study information

Verified date April 2020
Source Medical University of Warsaw
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 30, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. age between 18 and 80 years,

2. chronic cough lasting more than six months

3. earlier thorough diagnosing of cough reason

4. unsuccessful cough management despite at least 3 months of earlier treatment

5. no symptoms of any airway infection during last 4 weeks.

Exclusion Criteria:

1. lack of opportunity to participate in speech therapy sessions

2. cough lasting less than 6 months

3. active cigarette smoking

4. taking ACE inhibitors

5. symptoms of airway infection (other than cough).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Poland Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw Warsaw

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. Epub 2006 Jul 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cough severity measured by Visual Analogue Scale (VAS), range 0-100 mm, the more severe cough , the higher value in VAS score 3 months
Secondary Cough related quality of life 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
Secondary Sensitivity of cough reflex measured by cough challenge test with capsaicin 3 months
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