ClinicalTrials.gg
CompletedNCT03457610Updated Apr 15, 2020

Speech Therapy in the Management of Chronic Cough

An interventional study of Speech and language intervention in Cough and Speech Therapy, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-04-15.

Primary conditionChronic CoughRegistry: CoughReclassifiedWhy we changed it
Registry
Cough — the first condition term the registry derived for this study.
ClinicalTrials.gg
Chronic Cough
Why
  1. The study's title name Chronic Cough, a narrower term within Cough.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Jan 2016, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Cough
  • Speech Therapy

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Keywords

  • chronic cough
  • speech and language intervention
  • difficult-to-treat cough
03

In context

Chronic Cough Reclassified

142 studies on the registry are indexed under Chronic Cough; 39 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 104 interventional studies indexed under Chronic Cough.

Browse Chronic Cough studies →

Lead sponsor

Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.

Compared within Chronic Cough, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cough. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Speech and language intervention

    Behavioral: Speech and language intervention

Interventions

  • BehavioralSpeech 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.

    Also known as: Speech therapy, Voice therapy

06

What researchers measure

Primary outcomes

  1. Cough severity

    measured by Visual Analogue Scale (VAS), range 0-100 mm, the more severe cough , the higher value in VAS score

    Time frame: 3 months

Secondary outcomes

  1. 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

    Time frame: 3 months

  2. Sensitivity of cough reflex

    measured by cough challenge test with capsaicin

    Time frame: 3 months

07

Study locations

1 site
  • Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
    Warsaw, 02-097, Poland
08

References and documents

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. PubMed 17540788 ↗
  • 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. PubMed 16844725 ↗
  • 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. PubMed 26426314 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2016 to primary completion in Dec 2019, 47 months.

Of 20 interventional studies with no phase under Chronic Cough, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 48. This study's 47 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2018
First posted
Mar 7, 2018
StartActual
Jan 1, 2016
Primary completionActual
Dec 30, 2019
CompletionActual
Jan 30, 2020
Last update
Apr 15, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03457610
Responsible party
Marta Dąbrowska (Principal Investigator, Medical University of Warsaw) — Principal investigator
First posted
Mar 7, 2018
Start date
Jan 1, 2016
Primary completion
Dec 30, 2019
Completion
Jan 30, 2020
Last update
Apr 15, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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