They were instructed how to use the Turbuhaler, and how to avoid local side effects by rinsing the mouth with water and gargling after inhalation of the study medication. At the second visit, the study medication was discontinued and replaced by open treatment with budesonide Turbuhaler 400 |ig twice daily for a further two weeks. At visits 2 and 3, cough discomfort VAS, spirometry, blood and sputum measurements were repeated. Local side effects were recorded.
The primary outcome was improvement in cough discomfort as measured by the VAS, and this was, before analysis, considered clinically important only if cough discomfort was reduced by 50% or greater. Secondary outcomes were sputum total and differential cell counts, fluid phase eosinophil cationic protein (ECP), IL-8, fibrinogen, albumin and substance P, and local side effects from treatment.
Clinical methods: Subject and cough characteristics were documented by structured questionnaires. Cough discomfort was rated using a 9-point Likert scale where 1 was virtually unbearable, the most severe discomfort or distress ever, and 9 was absent, none at all. Cough discomfort in the previous two days was also graded by the subject on a 100 mm horizontal VAS, where zero was no cough and 100 was at its worst. Local side effects of inhaled budesonide were also assessed by a structured questionnaire and by oropharyngeal inspection. Spirometry, methacholine inhalation tests and allergy skin prick tests were performed by standard methods . Sputum was induced by the inhalation of an aerosol of hypertonic saline as described by Pin et al .