Lung Function and Reversibility Sample Clauses

Lung Function and Reversibility. At Visit 1, the highest of three technically acceptable measurements of FEV1, will be recorded before and 30 minutes after inhalation of 400µg salbutamol via MDI and VOLUMATIC spacer (ELLIPSE in US centres). The FVC and FEV1/FVC ratio, which is associated with the highest measurement of FEV1, will also be recorded in the CRF. At Visit 1, the % predicted normal values for FEV1 will be calculated and recorded in the CRF using the highest of the three measurements. At Visit 2 and at 24 weekly intervals thereafter (Visits 4, 6, 8, 10, 12 and 15) and also at Visit 16, measurement of FEV1 will be taken 30 minutes after inhalation of 400µg salbutamol via MDI and VOLUMATIC spacer (ELLIPSE in US centres). All values will be recorded in the CRF. All predicted normal values will be taken from ECCS tables [Quanjer, 1993]. At Visit 1 only, reversibility will be calculated as a percentage of the predicted normal FEV1 using the following formula: post-bronchodilator FEV1 – pre-bronchodilator FEV1 x 100% predicted normal FEV1 Subject eligibility: • A baseline (pre-bronchodilator) FEV1 of <60% of predicted normal. • A reversibility of < 10% of the predicted normal FEV1 30 minutes after inhalation of 400µg salbutamol via MDI and VOLUMATIC (ELLIPSE in US centres) spacer must be demonstrated at Visit 1. • A pre-bronchodilator FEV1/FVC ratio of ≤ 70% must be demonstrated at Visit 1 (the FVC measurement is that which is linked to the highest pre-bronchodilator FEV1 measurement). • Visit 1 measurements should be made having withheld short-acting bronchodilators for 6 hours and long-acting bronchodilators for 12 hours. If these criteria are not met at the start of Visit 1 then this visit should be rescheduled. • Subjects who do not meet these criteria cannot be entered into the study. Spirometry procedures: • Subjects should refrain from using short-acting bronchodilators for at least 6 hours and long-acting bronchodilators for at least 12 hours before the Visit 1 clinic lung function test is performed. Prior to the subsequent clinic visits, subjects may use their usual medication as normal (since lung function measurements will be conducted post-bronchodilator). • Where possible, lung function measurements should be performed at the same time of day, under BTPS conditions using the same spirometer at each clinic visit. The subject should be in the same position (i.e., sitting or standing) at each visit. • The spirometer should be regularly calibrated according to manufacturer re...
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