A Comprehensive Evaluation of the Impact of ATP on Laryngeal Symptoms, Hypersensitivity and Function (MISP COUGH)

Bispebjerg Hospital

Status

Enrolling

Conditions

Chronic Refractory Cough

Treatments

Diagnostic Test: Laryngeal sensitivity testing

Study type

Observational

Funder types

Other

Identifiers

NCT05570981

H-21076805

Details and patient eligibility

About

OBJECTIVES

To deliver a comprehensive model of laryngeal assessment, evaluating both the sensory and motor components of upper airway control and to relate this to symptom disturbance.
Determine if laryngeal control is altered by coughing and the impact of repeated coughing on overall laryngeal control and relaxation to its baseline state.
Evaluate if cell damage and tissue inflammation (including exposure to ATP) modulates laryngeal hypersensitivity and function, by using a comprehensive array of test modalities.

AIM To utilise state-of-the-art comprehensive assessment tools to evaluate laryngeal hypersensitivity and function in a cohort of individuals with chronic refractory cough and control subjects. The test modalities utilise direct stimulation of the laryngeal adductor reflex, measurement of laryngeal EMG and assessment of functional laryngeal response to an inhalational challenge with laryngoscopic techniques.

HYPOTHESIS Physiological markers of laryngeal hypersensitivity and dysfunction are highly prevalent in patients with chronic refractory cough and manifestations are driven by ATP stimulation.

OUTCOME MEASURES Measurements of laryngeal symptomatology will be measured over a run-in period and during challenge testing. Laryngeal relaxation will be studied using our novel tracking software capability, combining endoscopic imaging and physiological measurements of diaphragm activation.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria (controls)

Age ≥ 18 years
Healthy - with no history of any medical conditions
No history of asthma / allergies
Normal spirometric indices
Non smoker

Inclusion criteria (patients)

Age ≥ 18 years
Chronic cough as per ATS definition (>8 weeks duration)
High symptom burden (i.e. Cough VAS >= 40 mm at the screening visit)
Chest radiograph or CT within 3 years of the screening visit with no abnormalities considered to contribute to chronic cough
For patients with asthma: a confirmed diagnosis of asthma on the basis of asthma symptoms and reversible airflow obstruction (BDR 200mls + 12% change post bronchodilator and/or positive bronchoprovocation test).

Exclusion criteria

Current smoker or a smoking history of >10 pack years
Asthma that is not well-controlled, as per international asthma guidelines as specified by Global Initiative for Asthma (GINA)
Recent exacerbation of cough or asthma within 4 weeks of inclusion
Pregnancy or childbearing potential and no contraceptive treatment
Respiratory tract infection within 4 weeks of inclusion
Currently taking any of the following medications:
- ACE inhibitors and within 3 months of inclusion
- Antitussives (opioids, pregabalin, gabapentin, amitriptyline, nortriptyline or over-the-counter medications) within 2 weeks of inclusion
- Medical treatments for GORD, eosinophilic bronchitis or other cough related conditions, initiated or changed (i.e. not in a stable regimen) for 4 weeks prior to inclusion.
Medical history of COPD or chronic bronchitis
Medical conditions/history or other circumstances which, in the judgement of the investigator, could increase the risk of adverse events or bias the study results