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: • 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 recommendations and the calibration log kept. • It is mandatory to only use spirometers that can print ...
Sample 1
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Related to Lung Function and Reversibility

  • CERTIFYING FUNCTION Department of Information Resources acting as the owner of the DIR Contracts hereby certifies the eligibility of the DIR Customer to use the DIR Contracts.

  • MANAGEMENT FUNCTIONS B.1 The Association recognizes that the management of the Hospital and the direction of working forces are fixed exclusively in the Hospital and shall remain solely with the Hospital except as specifically limited by the provisions of this Agreement and, without restricting the generality of the foregoing, the Association acknowledges that it is the exclusive function of the Hospital to: (a) maintain order, discipline and efficiency; (b) hire, assign, retire, discharge, direct, promote, demote, classify, transfer, lay- off, recall, and suspend or otherwise discipline nurses, provided that a claim of discharge or discipline without just cause may be the subject of a grievance and dealt with as hereinafter provided; (c) determine, in the interest of efficient operation and high standards of service, job rating and classification, the hours of work, work assignments, methods of doing the work, and the working establishment for the service; (d) generally to manage the operation that the Hospital is engaged in and, without restricting the generality of the foregoing, to determine the number of personnel required, methods, procedures, and equipment in connection therewith; (e) make, enforce, and alter from time to time reasonable rules and regulations to be observed by the nurses which are not inconsistent with the provisions of this Agreement. B.2 These rights shall not be exercised in a manner inconsistent with the provisions of this Agreement.

  • Monitoring and Reporting The Programme Operator shall monitor, record and report on progress towards the programme’s outcomes in accordance with the provisions contained in the legal framework. The Programme Operator shall ensure that suitable and sufficient monitoring and reporting arrangements are made with the project promoters in order to enable the Programme Operator and the National Focal Point to meet its obligations to the Donors. When reporting on progress achieved in Annual and Final Programme Reports, the Programme Operator shall disaggregate results achieved as appropriate and in accordance with instructions received from the FMO.

  • Safeguards Monitoring and Reporting The Borrower shall do the following or cause the Project Executing Agency to do the following:

  • Monitoring and Review The Provider agrees to allow access to the Department for purposes of monitoring and review. This access includes but is not limited to client records, fiscal records, staffing records, policy and procedural manuals, facilities, staff, and children in care of the Department. The Department will conduct quality reviews, which may include site-based quality review visits.

  • CUSTOMER SERVICE FUNCTIONS The Servicer shall handle all Customer inquiries and other Customer service matters according to the same procedures it uses to service Customers with respect to its own charges.

  • Money Market Fund Compliance Testing and Reporting Services Subject to the authorization and direction of the Trust and, in each case where appropriate, the review and comment by the Trust’s independent accountants and legal counsel, and in accordance with procedures that may be established from time to time between the Trust and the Administrator, the Administrator will:

  • Additional Functions Upon receipt of Proper Instructions, the Custodian shall take all such other actions as specified in such Proper Instructions and as shall be reasonable or necessary with respect to Repurchase Agreement transactions and the Securities and funds transferred and received pursuant to such transactions, including, without limitation, all such actions as shall be prescribed in the event of a default under a Repurchase Agreement.

  • MIXED FUNCTIONS An employee engaged for more than two hours during one day or shift on duties carrying a higher rate than his or her ordinary classification shall be paid the higher rate for such day or shift. If for two hours or less during one day or shift he or she shall be paid the higher rate for the time so worked.

  • PERFORMANCE MONITORING AND REPORTING Performance indicators

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