Chronic idiopathic cough and inducible laryngeal obstruction (ILO) Respiratory Chronic idiopathic cough, inducible laryngeal obstruction
Conditions
Interventions
On the first two visits, participants will be asked to complete a standard cough challenge (where an increasing amount of challenge solution is inhaled through a mouth piece) at the same time as havin
Sponsors
Manchester NHS Foundation Trust, Wythenshawe Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All participants: 1. Aged >18 years 2. Non-smoker for at least 6 months 3. No evidence of active asthma Healthy volunteers: 4. In good general health with no clinically relevant abnormalities based on the medical history, physical examination, vital signs 5. Aged >45 years to broadly age-match to patient groups 6. No history of current or significant past respiratory disease, specifically a previous diagnosis of asthma ILO patients: 7. An established diagnosis of ILO based on clinical evaluation AND visualisation of laryngeal obstruction during a symptomatic episode Chronic cough patients: 8. Refractory/idiopathic chronic cough as defined by BTS guidelines (i.e. normal radiology, no airflow obstruction on spirometry and have asthma, gastro-oesophageal reflux disease and nasal disease excluded based on symptoms/investigations and trials of treatment where appropriate)
Exclusion criteria
Exclusion criteria: 1. Current and ex-smokers with cumulative history of >20 pack years 2. FEV1/FVC 50 ppb 4. Eosinophilia blood count >0.45 5. Expiratory airflow obstruction on flow volume loop 6. Pregnant or breastfeeding 7. Upper or lower respiratory tract infection within last 4 weeks or recent significant change in pulmonary status within 4 weeks of study visit 8. Have received any medications likely to modulate cough or upper airway symptoms (e.g. ACE inhibitors, opioids, gabapentin etc.) within 2 weeks of study visit. Patients can be included if they are willing/able to discontinue these for the duration of the study 9. Have received any non-pharmacological therapy interventions for ILO, ICC or upper airway symptoms (e.g. muscle tension dysphonia, globus pharyngeus) 10. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgement of the Investigator or Sponsor, would make the subject inappropriate for entry into this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The level of citric acid evoking laryngeal obstruction in the ILO subjects, as determined by the speech and language therapist who is viewing the larynx via the laryngoscope throughout testing | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Spirometry performed pre and post inhalation and flow volume loops 2. Sensation: the following will be recorded on a 100 mm visual analogue scale after each inhalation challenge: 2.1. Intensity of sense of taste 2.2. Intensity of symptoms in throat/upper chest 2.3. Intensity of something in throat unable to clear 2.4. Intensity of breathing difficulty 3. Objective cough monitoring measured throughout the inhalation challenge. Measurements will be recorded specifically 10 seconds after each incremental dose 4. The VCDQ (acute) questionnaire and the Leicester Cough Questionnaire (acute) will be administered post inhalation challenge | — |
Countries
England, United Kingdom
Contacts
Public ContactJemma Haines
Outcome results
None listed