Asthma, chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF) or chronic cough Respiratory 1. Asthma 2. Chronic obstructive pulmonary disease (COPD) 3. Idiopathic pulmonary fibrosis (IPF) 4. Chronic cough
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All participants: 1. Aged 18 years and over Healthy volunteers: 1. Normal spirometry 2. No current or past history of chronic cough or respiratory disease 3. Non-smokers or ex-smokers (>6months abstinence) with smoking history of = 10 pack years Asthma: 1. Physician diagnosis of asthma 2. Evidence of airways hyper-responsiveness to methacholine (PC2012% FEV1) within the last 2 years. 3. Non-smokers or ex-smoker (>6months abstinence) with a smoking history of = 20 pack years 4. The subjects treated with: 4.1. Short acting Beta 2 Agonist PRN 4.2. AND/OR inhaled corticosteroid (=250mcg fluticasone propionate daily or equivalent) COPD 1. Physician diagnosis of COPD 2. Ex-smokers (> 6 months abstinence) with smoking history of = 20 pack years 3. Spirometry demonstrating airflow obstruction i.e. FEV1/FVC ratio 6months abstinence) with a smoking history of =20 pack years Refractory Chronic Cough 3. History of a dry/minimally productive cough for 12 months 4. Normal spirometry 5. No clinically significant findings to explain chronic cough on CXR or CT scan of thorax 6. Completed appropriate investigation and/or trials of treatment for common causes of chronic cough 7. Non-smokers or ex-smoker (>6months abstinence) with a smoking history of =20 pack years
Exclusion criteria
Exclusion criteria: All participants: 1. Ex-smokers with 165/95 mmHg despite adequate medical therapy). 13. Allergy or intolerance of salbutamol Asthma: 1. Subjects treated with high dose inhaled corticosteroid (>250mcg fluticasone propionate daily or equivalent) Idiopathic Pulmonary Fibrosis 1. High dose systemic steroids i.e. prednisolone >20mg daily or equivalent. Those patients on lower doses of steroids for >1 month may be included 2. Resting blood oxygen saturation of <90 % 3. Concurrent use of pirfenidone, unless receiving a stable dose for at least 4 weeks prior to screening 4. A history of concomitant asthma or obstructive airway disease, or those with an FEV1/FVC ratio at screening of <70%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal cough response (Emax) is measured through inhalation tests at study visits 1, 2, 3, 4 and 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Irritant concentration evoking 50% of maximum cough response (ED50) is measured through inhalation tests at study visits 1, 2, 3, 4 and 5 2. Cough severity is measured using visual analogue scale (VAS) at study visits 1, 2, 3, 4 and 5 3. Cough specific quality of life is measured using the Leicester Cough Questionnaire at the first study visit | — |
Countries
England, United Kingdom