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

NCT04758351 | Completed

• 1 other identifier: 59689
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Cough

Keywords

Evaluation; Patient reported; Effectiveness; Treatment; Secondary Care

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (11)

• Correlation in change of objective cough frequency and healthcare utilization

  3 months

• Correlation in change of objective cough frequency and lost productivity

  3 months

• Correlation in change of objective cough frequency and work productivity and activity

  3 months

• Correlation in change of quality of life and healthcare utilization

  3 months

• Correlation in change of quality of life and lost productivity

  3 months

Other Outcomes (4)

• Correlation in exhaled nitric oxide, blood eosinophils, and sputum eosinophils and objective cough frequency and subjective patient reported outcomes

  3 months

• Changes in the quality of life

  3 months

• Changes in the perceived disease

  3 months

Study Arms (1)

Cases - Patients with chronic cough

Patients referred to secondary care clinic for investigation and treatment for explained chronic cough, refractory chronic cough, and unexplained chronic.

Other: Usual clinical practice

Interventions

Usual clinical practice OTHER

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

Cases - Patients with chronic cough

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• McMaster University: lead
• Merck Canada Inc.: collaborator
• University of Manchester: collaborator
• University of British Columbia: collaborator

Study Sites (1)

Imran Satia

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (6)

• 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.

  PMID: 25657027 BACKGROUND

• 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.

  PMID: 16428686 BACKGROUND

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

  PMID: 14514949 BACKGROUND

• 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.

  PMID: 16428693 BACKGROUND

• 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.

  PMID: 24337140 BACKGROUND

• 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.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Remaining cells and supernatant from sputum processing will be stored and used to analyze neuro-inflammatory cytokines and protein biomarkers.

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

• Imran Satia, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 17, 2021
• Study Start: December 14, 2021
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 6, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)