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Chronic CoughPROCOUGHNCT04758351

Prospective Study on the Evaluation, Patient Reported Outcomes and Effectiveness of Treatment for Chronic Cough

An observational study of Chronic Cough, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Chronic cough is a common troublesome symptom which has a global prevalence of approximately 10%, but with wide variations across continents. The aim of this study is to evaluate the effectiveness of treatment, patient-reported outcomes and burden of disease in patients with chronic cough referred to a specialist… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Cough
What is being tested?
Usual clinical practice
How many people
100 participants
Where
1 siteCanada
Study dates
14 Dec 2021to 30 Apr 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients referred to secondary care for investigation and treatment of explained chronic cough, refractory chronic cough, and unexplained chronic cough.

Who may be able to join

  • Aged ≥18-75
  • Patients referred to a specialist primarily with a history of chronic cough (cough lasting >8 weeks)
  • Normal Chest X-ray
  • No Evidence of Airflow Obstruction

Who cannot join

  • Subjects who are currently established on treatment and their chronic cough is well controlled.
  • Unable to perform acceptable and reproducible spirometry.
  • Current smoker or ex-smoker with ≥20 pack-year smoking history and abstinence of ≤6 months
  • Symptoms of upper respiratory tract infection in the last 1 month which have not resolved
  • Lower respiratory tract infection or pneumonia in the last 1 month
  • Asthma exacerbation in the previous month requiring an increase or start of an inhaled corticosteroid or oral corticosteroid
Show all 10Show fewer
  • Significant other primary pulmonary disorders in particular; pulmonary embolism, pulmonary hypertension, lung cancer, cystic fibrosis, significant radiologically proven emphysema, interstitial lung disease or bronchiectasis.
  • Any centrally acting medication within the last 2 weeks which in the view of the investigator could influence the coughing. Any participant who is taking amitriptyline, dextromethorphan, pregabalin, gabapentin or opioids will not be eligible to take part in this study unless they are willing and medically able to withdraw from such medication before the start of visit 1. The reason for this is that centrally-acting medications may influence coughing rates at baseline.
  • History of psychiatric illness, drug or alcohol abuse which may interfere in the participation of the trial.
  • Positive Covid-19 test within 2 weeks of screening visit.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Imran Satia

    Hamilton, Ontario, L8S 4L8

Other trials in Canada

About this study

Official title: Prospective Study on the Evaluation, Patient Reported Outcomes and Effectiveness of Treatment for Chronic Cough in Secondary Care

Chronic cough is a common troublesome symptom which has a global prevalence of approximately 10%, but with wide variations across continents. The aim of this study is to evaluate the effectiveness of treatment, patient-reported outcomes and burden of disease in patients with chronic cough referred to a specialist clinic. The proposed study will use pre-defined diagnostic criteria, investigations and treatment algorithms such that all recruited patients will undergo the same investigations and follow a set management algorithm. This study will objectively and subjectively assess coughing at baseline and after treatment in a real-world clinical setting. This will allow us to understand the relationship between any objective reduction in cough after treatment, and whether this translates to any significant improvement in subjective questionnaire scores. We will assess the impact of health conditions on lost productivity in monetary units and assess the amount of absenteeism, presenteeism and daily activity impairment attributable to unexplained chronic cough/refractory chronic cough. Finally, a patient survey at the end of the study will evaluate the patients' satisfaction and experience of investigation, management trials and use of questionnaires.

Read the detailed description

This is a prospective observational single-center study of patients referred to secondary care for investigation and management of explained chronic cough, refractory chronic cough, and unexplained chronic cough. The study will have 4 research visits integrated between standard clinical visits. Patients will be recruited from secondary care clinics. Patient eligibility will be assessed against the study inclusion/exclusion criteria and patients will undergo informed consent in the research centre. Subjects who provide informed consent and are enrolled in the study will undergo screening procedures.

At Visit 1 (screening) data on demographics and medical history will be collected and a complete physical examination will be conducted. Subjects will undergo skin prick testing and spirometry and complete self-reported questionnaires (Leicester Cough Questionnaire, Valuation of Lost Productivity, Work Productivity, Activity, and Impairment, Healthcare Resource Utilization, Reflux Disease Questionnaire, Sino-Nasal Outcome Test, and Global Rating of Change Scale). Subjects will be fitted with a 24-hour cough monitor.

At Visit 2, the 24-hour cough monitor will be removed. Subjects will undergo blood sampling, methacholine challenge, sputum induction, and provide a urine sample.

Between Visits 2 and 3, physicians will provide a single clinical treatment pathway to address the most likely cause of chronic cough. Treatment for chronic cough will be in line with current clinical practice guidelines published by the European Respiratory Society Taskforce on Chronic Cough. Treatment plans will range from 2 weeks to 3 months.

Visit 3 will occur 2 weeks to 3 months following subjects' second clinical visit. Subjects will complete self-reported questionnaires (Leicester Cough Questionnaire, Valuation of Lost Productivity, Work Productivity, Activity, and Impairment, Reflux Disease Questionnaire, Sino-Nasal Outcome Test, and Global Rating of Change Scale) and be fitted with a 24-hour cough monitor.

At Visit 4 the 24-hour cough monitor will be removed. Subjects will undergo blood sampling, sputum induction, and provide a urine sample. Subjects will complete a patient satisfaction survey.

All study procedures will be performed according to local standard operating procedures and be conducted by trained and experienced staff with supervision by medical doctors. Safety will be assessed throughout the study by monitoring for adverse events and serious adverse events.

Conditions
Chronic Cough
Being tested
Usual clinical practice
Keywords
Evaluation, Patient reported, Effectiveness, Treatment, Secondary Care
Medical subject headings
Chronic Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual clinical practiceOther

    Based on European Respiratory Society guidelines on management for chronic cough.

Study groups in NCT04758351
Study groupRoleWhat they receive
Cases - Patients with chronic coughPatients referred to secondary care clinic for investigation and treatment for explained chronic cough, refractory chronic cough, and unexplained chronic.
Receives: Other: Usual clinical practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in objective cough frequency

    Change in objective cough frequency pre- and post-treatment among patients referred to secondary care for treatment of explained chronic cough, refractory chronic cough, and unexplained chronic cough.

    Measured: 3 months

Secondary outcomes (11)
  1. Correlation in change of objective cough frequency and healthcare utilization

    Correlation between pre- and post-treatment change in objective cough frequency and Healthcare Related Utilization among patients referred to secondary care for treatment of explained chronic cough, refractory chronic cough, and unexplained chronic cough. Healthcare utilization is measured by recording the number of visits to family physician, outpatient specialist, number of tests, and medication use.

    Measured: 3 months

  2. Correlation in change of objective cough frequency and lost productivity

    Correlation between pre- and post-treatment change in objective cough frequency and lost productivity among patients referred to secondary care for treatment of explained chronic cough, refractory chronic cough, and unexplained chronic cough. Lost productivity is measured using the Valuation of Lost Productivity questionnaire which contains a series of questions that evaluate the impact of functional impairment on productivity loss, not just for the individual but also on the work environment.

    Measured: 3 months

  3. Correlation in change of objective cough frequency and work productivity and activity

    Correlation between pre- and post-treatment change in objective cough frequency and work productivity and activity among patients referred to secondary care for treatment of explained chronic cough, refractory chronic cough, and unexplained chronic cough. Work productivity and activity is measured using the Work Productivity and Activity Impairment Questionnaire which is a 6-item self-administered questionnaire used to assess productivity and impairment because of a specific health problem such as chronic cough.

    Measured: 3 months

  4. Correlation in change of quality of life and healthcare utilization

    Correlation between pre- and post-treatment change in quality of life and Healthcare Related Utilization among patients referred to secondary care for treatment of explained chronic cough, refractory chronic cough, and unexplained chronic cough. Quality of life is measured using the Leicester Cough Questionnaire. The Leicester Cough Questionnaire is a 7 point Likert scale with a minimum value of 1 indicating chronic cough impacts participant life all of the time and a maximum value of 7 indicating chronic cough impacts participant life none of the time. Healthcare utilization is measured by recording the number of visits to family physician, outpatient specialist, number of tests, and medication use.

    Measured: 3 months

  5. Correlation in change of quality of life and lost productivity

    Correlation between pre- and post-treatment change in quality of life and lost productivity among patients referred to secondary care for treatment of explained chronic cough, refractory chronic cough, and unexplained chronic cough. Quality of life is measured using the Leicester Cough Questionnaire. The Leicester Cough Questionnaire is a 7 point Likert scale with a minimum value of 1 indicating chronic cough impacts participant life all of the time and a maximum value of 7 indicating chronic cough impacts participant life none of the time. Lost productivity is measured using the Valuation of Lost Productivity questionnaire which contains a series of questions that evaluate the impact of functional impairment on productivity loss, not just for the individual but also on the work environment.

    Measured: 3 months

  6. Correlation in change of quality of life and work productivity and activity

    Correlation between pre- and post-treatment change in quality of life and work productivity and activity among patients referred to secondary care for treatment of explained chronic cough, refractory chronic cough, and unexplained chronic cough. Quality of life is measured using the Leicester Cough Questionnaire. The Leicester Cough Questionnaire is a 7 point Likert scale with a minimum value of 1 indicating chronic cough impacts participant life all of the time and a maximum value of 7 indicating chronic cough impacts participant life none of the time. Work productivity and activity is measured using the Work Productivity and Activity Impairment Questionnaire which is a 6-item self-administered questionnaire used to assess productivity and impairment because of a specific health problem such as chronic cough.

    Measured: 3 months

  7. Patient satisfaction

    Patient satisfaction measurements of clinical investigations, treatment, and use of questionnaires among patients referred to secondary care for treatment of explained chronic cough, refractory chronic cough, and unexplained chronic cough. Patient satisfaction will be measured using a 5 point Likert scale where the minimum value is 1 indicating participants were very unsatisfied and the maximum value is 5 indicating participants were very satisfied.

    Measured: 3 months

  8. Comparison of change in objective cough frequency and quality of life

    Comparison of pre- and post treatment change in objective cough frequency and quality of life among patients referred to secondary care for treatment of explained chronic cough, refractory chronic cough, and unexplained chronic cough. Quality of life is measured using the Leicester Cough Questionnaire. The Leicester Cough Questionnaire is a 7 point Likert scale with a minimum value of 1 indicating chronic cough impacts participant life all of the time and a maximum value of 7 indicating chronic cough impacts participant life none of the time.

    Measured: 3 months

  9. Comparison of change in objective cough frequency and participant perceived change in condition

    Comparison of pre- and post-treatment change in objective cough frequency and perceived change in condition among patients referred to secondary care for treatment of explained chronic cough, refractory chronic cough, and unexplained chronic cough. Perceived change in condition is measured using the Global Rating of Change Scale which is a 15 value scale. The Global Rating of Change Scale is a 15 point scale with a minimum value of -7 indicating a worse outcome and a maximum value of +7 indicating a better outcome.

    Measured: 3 months

  10. Measure the relationship between objective cough frequency and lost productivity

    Measure the post treatment relationship between objective cough frequency and lost productivity among patients referred to secondary care for treatment of explained chronic cough, refractory chronic cough, and unexplained chronic cough. Lost productivity is measured using the Valuation of Lost Productivity questionnaire which contains a series of questions that evaluate the impact of functional impairment on productivity loss, not just for the individual but also on the work environment.

    Measured: 3 months

  11. Measure the relationship between objective cough frequency and work productivity and activity

    Measure the post treatment relationship between objective cough frequency and work productivity and activity among patients referred to secondary care for treatment of explained chronic cough, refractory chronic cough, and unexplained chronic cough. Work productivity and activity is measured using the Work Productivity and Activity Impairment Questionnaire which is a 6-item self-administered questionnaire used to assess productivity and impairment because of a specific health problem such as chronic cough.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2021
  2. Study start14 Dec 2021
  3. Primary completion30 Apr 2025
  4. Study completion30 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04758351
Sponsor's protocol ID
59689
Acronym
PROCOUGH
Status last verified
Sep 2024
First submitted
5 Feb 2021
Last updated
6 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Song WJ, Chang YS, Faruqi S, Kim JY, Kang MG, Kim S, Jo EJ, Kim MH, Plevkova J, Park HW, Cho SH, Morice AH. The global epidemiology of chronic cough in adults: a systematic review and meta-analysis. Eur Respir J. 2015 May;45(5):1479-81. doi: 10.1183/09031936.00218714. Epub 2015 Feb 5. No abstract available.

    PubMed 25657027
  • Irwin RS, Baumann MH, Bolser DC, Boulet LP, Braman SS, Brightling CE, Brown KK, Canning BJ, Chang AB, Dicpinigaitis PV, Eccles R, Glomb WB, Goldstein LB, Graham LM, Hargreave FE, Kvale PA, Lewis SZ, McCool FD, McCrory DC, Prakash UBS, Pratter MR, Rosen MJ, Schulman E, Shannon JJ, Hammond CS, Tarlo SM. Diagnosis and management of cough executive summary: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):1S-23S. doi: 10.1378/chest.129.1_suppl.1S. No abstract available.

    PubMed 16428686
  • Morice AH, Kastelik JA. Cough. 1: Chronic cough in adults. Thorax. 2003 Oct;58(10):901-7. doi: 10.1136/thorax.58.10.901.

    PubMed 14514949
  • Pratter MR. Overview of common causes of chronic cough: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):59S-62S. doi: 10.1378/chest.129.1_suppl.59S.

    PubMed 16428693
  • Sadatsafavi M, Rousseau R, Chen W, Zhang W, Lynd L, FitzGerald JM. The preventable burden of productivity loss due to suboptimal asthma control: a population-based study. Chest. 2014 Apr;145(4):787-793. doi: 10.1378/chest.13-1619.

    PubMed 24337140
  • Andreasson E, Svensson K, Berggren F. PRP11 The validity of the work productivity and activity impairment questionnaire for patients with asthma (WPAIASTHMA): Results from a web-based study. Value in Health. 2003;6(6):780.

  • Wahab M, Kum E, Diab N, Brister D, Oliveira A, Hassan W, Beaudin S, Stevens C, Wattie J, Wiltshire L, Howie K, Killian K, Sehmi R, Gauvreau GM, O'Byrne PM, Satia I. Moving Beyond Responders: A Post Hoc Analysis Identifying Criteria for Chronic Cough Control. Chest. 2026 May 14:S0012-3692(26)00636-7. doi: 10.1016/j.chest.2026.05.006. Online ahead of print.

    PubMed 42140485

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Cough, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in objective cough frequency (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04758351, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.

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