An observational study in Chronic Refractory Cough, sponsored by Bispebjerg Hospital. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-01.
Sponsored by Bispebjerg Hospital · Observational
OBJECTIVES
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's planned enrollment of 30 is below the median of 115 across 479 observational studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Bispebjerg Hospital is the lead sponsor of 281 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients (≥ 18 years) with chronic refractory cough and age-/gender matched healthy controls.
Inclusion criteria (controls)
Inclusion criteria (patients)
Exclusion criteria
Currently taking any of the following medications:
Individuals with a diagnosis of chronic refractory cough
Diagnostic Test: Laryngeal sensitivity testing
Healthy control subjects matched to the CRC group by age and gender
Diagnostic Test: Laryngeal sensitivity testing
Direct stimulation of the laryngeal adductor reflex, measurement of laryngeal EMG and our capability to assess functional laryngeal response to an inhalational challenge with laryngoscopic techniques.
Maximal decrease in glottic anterior angle (degrees) during challenge testing
The maximal decrease in glottic anterior angle during challenge testing
Time frame: Baseline measurement is taken immediately before beginning the challenge test. Minimal value is taken from continuously measured glottic anterior angle, from immediately after baseline measurement and until immediately after challenge testing
Maximal increase in glottic anterior angle (degrees) after challenge testing
The difference between the minimal glottic anterior angle observed during challenge testing and the maximal glottic anterior angle observed from immediately after challenge testing and until 5 minutes after challenge testing
Time frame: During challenge testing and from immediately after challenge testing until 5 minutes after challenge testing
Maximal laryngeal relaxation time (seconds)
Maximum time for glottic angle to normalise (i.e. achieve a value equal to or above the value prior to sensory stimulus)
Time frame: At baseline, during challenge testing and from immediately after challenge testing until 5 minutes after challenge testing
Change in laryngeal relaxation time (seconds) during challenge testing
Change in time for glottic angle to normalise (i.e. achieve a value equal to or above the value prior to sensory stimulus)
Time frame: At baseline and immediately after challenge testing
Change in laryngeal relaxation time (seconds) in recovery
Change in time for glottic angle to normalise (i.e. achieve a value equal to or above the value prior to sensory stimulus)
Time frame: Immediately after challenge testing and at 5 minutes after challenge testing
Cough VAS (0-100 mm)
This is a descriptive delineation of the ATP/Cough VAS dose/response relationship. The measure is taken at multiple times (see Time Frame) and visualised graphically.
Time frame: At baseline, during challenge testing at minutes 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30 and 4:00 (from immediately after an administered dose of ATP and until 15 seconds after an administered dose) and immediately after challenge testing
Cough count and frequency
This is a descriptive delineation of the ATP/Cough count dose/response relationship. The measure is taken at multiple times (see Time Frame) and visualised graphically.
Time frame: At baseline, during challenge testing at minutes 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30 and 4:00 (from immediately after an administered dose of ATP and until 15 seconds after an administered dose) and immediately after challenge testing
Breathing frequency (1/minute)
This is a descriptive delineation of the ATP/Breathing frequency dose/response relationship. The measure is taken at multiple times (see Time Frame) and visualised graphically.
Time frame: At baseline, during challenge testing at minutes 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30 and 4:00 (from immediately after an administered dose of ATP and until 15 seconds after an administered dose) and immediately after challenge testing
Breathing frequency variability (entropy, unitless)
This is a descriptive delineation of the ATP/Breathing frequency variability dose/response relationship. The measure is taken at multiple times (see Time Frame) and visualised graphically.
Time frame: At baseline, during challenge testing at minutes 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30 and 4:00 (from immediately after an administered dose of ATP and until 15 seconds after an administered dose) and immediately after challenge testing
Tidal volume (Litres)
This is a descriptive delineation of the ATP/Tidal volume dose/response relationship. The measure is taken at multiple times (see Time Frame) and visualised graphically.
Time frame: At baseline, during challenge testing at minutes 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30 and 4:00 (from immediately after an administered dose of ATP and until 15 seconds after an administered dose) and immediately after challenge testing
Tidal volume variability (entropy, unitless)
This is a descriptive delineation of the ATP/Tidal volume variability dose/response relationship. The measure is taken at multiple times (see Time Frame) and visualised graphically.
Time frame: At baseline, during challenge testing at minutes 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30 and 4:00 (from immediately after an administered dose of ATP and until 15 seconds after an administered dose) and immediately after challenge testing
Diaphragm activation (Root Mean Square of EMG mcV in a rolling 50ms window centered at the measureing point)
This is a descriptive delineation of the ATP/Diaphragm activation dose/response relationship. The measure is taken at multiple times (see Time Frame) and visualised graphically.
Time frame: At baseline, during challenge testing at minutes 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30 and 4:00 (from immediately after an administered dose of ATP and until 15 seconds after an administered dose) and immediately after challenge testing
Oesophageal pressure (cmH2O)
This is a descriptive delineation of the ATP/Oesophageal pressure dose/response relationship. The measure is taken at multiple times (see Time Frame) and visualised graphically.
Time frame: At baseline, during challenge testing at minutes 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30 and 4:00 (from immediately after an administered dose of ATP and until 15 seconds after an administered dose) and immediately after challenge testing
Gastric pressure (cmH2O)
This is a descriptive delineation of the ATP/Gastric pressure dose/response relationship. The measure is taken at multiple times (see Time Frame) and visualised graphically.
Time frame: At baseline, during challenge testing at minutes 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30 and 4:00 (from immediately after an administered dose of ATP and until 15 seconds after an administered dose) and immediately after challenge testing
Trans-diaphragmatic pressure (cmH2O)
This is a descriptive delineation of the ATP/Transdiaphragmatic pressure dose/response relationship. The measure is taken at multiple times (see Time Frame) and visualised graphically.
Time frame: At baseline, during challenge testing at minutes 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30 and 4:00 (from immediately after an administered dose of ATP and until 15 seconds after an administered dose) and immediately after challenge testing
Single cough episode duration (seconds)
Time frame: At baseline, during challenge testing at minutes 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30 and 4:00 (from immediately after an administered dose of ATP and until 15 seconds after an administered dose) and immediately after challenge testing
Single cough episode intensity VAS (0-100 mm)
Time frame: At baseline, during challenge testing at minutes 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30 and 4:00 (from immediately after an administered dose of ATP and until 15 seconds after an administered dose) and immediately after challenge testing
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bispebjerg Hospital