Respiratory diseases Respiratory Other diseases of the respiratory system
Conditions
Interventions
1. At power 80% and p < 0.05 and based on a clinically relevant change of 2.7 (seen in our pilot study) we require 33 patients in each group. Allowing for a 25% drop out we require 88 patients, 44 in
patients are given advice and education on trigger avoidance and taught cough suppression exercises such as swallowing, re-hydration and breathing control
7. Further management addresses, voice disord
Sponsors
King's College Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with an isolated stable chronic cough >2 months in duration, normal chest X-ray and spirometry 2. Persistent cough despite negative investigations and/or failed treatment trials for asthma, reflux and rhinitis 3. Chronic cough >2 months 4. Cough is the major respiratory symptom 5. Sputum production absent or minimal (less than tablespoon/10ml a day) 6. Patients with chronic asthma and Chronic Obstructive Pulmonary Disease (COPD) may be included in the study where their principle problem is cough (as felt by the patient) 7. Male or female 8. Upper Age Limit 100 years; Lower Age Limit 17 years
Exclusion criteria
Exclusion criteria: 1. Upper respiratory tract infection in past 4 weeks 2. Taking angiotensin converting enzyme inhibitor medication 3. Current smokers 4. Patients with the following diagnoses of known respiratory disease will be excluded: 4.1. Lung cancer 4.2. Pneumonia 4.3. Pulmonary fibrosis 4.4. Sarcoidosis 4.5. Pleural effusion 4.6. Bronchiectasis and upper airway aspiration 5. Patients with chronic/ acute asthma / COPD will be excluded from the study where their primary problem is not felt to be cough, ie primary problem may be breathlessness, excess sputum production or fatigue 6. Patients with suspicious throat or layngeal mass, or with evidence of active aspiration (observed via Fibreoptic Endoscopic Evaluation of Swallowing (FEES) will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cough-related quality of life: Leicester Cough Questionnaire (QOL) assessed at start of study and at each PSALTI session and at 3 months post PSALTI treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cost effectiveness 2. Short Form 36 will be completed pre, post and at 3 months post intervention 3. Cough frequency 4. The Leicester Cough Monitor is a validated, objective, 24-hour ambulatory cough monitoring device 5. Cough Intensity: Capsaicin Cough Challenge measured before and at end of treatment period 6. Cough symptom severity 7. Visual analogue scale (VAS, 0-100mm). This simple VAS will be completed at each visit | — |
Countries
United Kingdom
Outcome results
None listed