VIDA SIGNIFICANT ASTHMA EXACERBATION (Visits 2-10, 88 and 90-92)
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1 VIDA SIGNIFICANT ASTHMA EXACERBATION (Visits 2-10, 88 and 90-92) Part. ID: - - Part. Initials: Visit: Visit Date: / / 20 Coordinator ID: (Coordinator Completed) For participants who meet treatment failure criteria, complete this form to assess for the occurrence of a significant asthma exacerbation. Submit this form to the DCC only if the participant meets exacerbation criteria. 1. Did the participant fail to respond within 48 hours to the treatment failure rescue algorithm? 2. Did the participant use at least 16 puffs of PRN levalbuterol per 24 hours for a period of 48 hours? (Do not complete Q3 at Visits 2 and 3) 3. Did the participant experience prebronchodilator FEV 1 values < 50% of the baseline prebronchodilator value obtained at Visit 3 on two consecutive spirometric determinations made on different days? (Do not complete Q4 at Visits 2 and 3) 4. Did the participant experience prebronchodilator FEV 1 values < 40% of predicted on two consecutive spirometric determinations made on different days? (1000) 1 Yes 0 No (1010) 1 Yes 0 No (1020) 1 Yes 0 No 9 Not evaluated (1030) 1 Yes 0 No 9 Not evaluated 5. Did the study or treating physician prescribe the participant (1035) oral/parenteral corticosteroids for the treatment of his/her 1 Yes 0 No asthma? If YES, record the oral/parenteral corticosteroids on the Concomitant Medications for Asthma/Allergy and Adverse Events (CMED) form. 6. Did the participant experience a significant asthma exacerbation in the opinion of the study investigator or personal physician? (1040) 1 Yes 0 No 7. Did the participant experience a significant asthma exacerbation? If any of the shaded boxes in Q1-Q6 is filled in, the participant experienced an asthma exacerbation. (1050) 1 Yes 0 No If YES, complete Q8 and record the exacerbation on the Clinical Adverse Events (AECLIN) form using ICD-9 code If NO, STOP HERE and continue with remaining visit procedures. Do NOT submit this form to the DCC. 8. Date exacerbation conditions were met (1060) / / 20 MM DD YYYY COMMENTS: (6000) 05/08/2012 version2.0 Page 1 of 1 *P1_sigex*
2 VIDA TREATMENT FAILURE CHECKLIST Part. ID: - - Part. Initials: Visit: Visit Date: / / 20 Coordinator ID: (Coordinator Completed) Complete this form at all visits from Visit 3 until the end of the study to assess the participant for treatment failure criteria. If a participant experiences treatment failure during the run-in and is seen prior to Visit 3, complete a single form using visit number 2. (Visits Only) 1. Complete the number of the last regular visit completed (1000) 2. Did the participant experience a fall in prebronchodilator PEF to < 65% of baseline on two out of three consecutive, scheduled (AM or PM) measurements? Refer to the VIDA Baseline PEF and Rescue Use Values (P1_BASELINE) form. 3. Did the participant experience an increase in rescue levalbuterol use of 8 or more puffs per 24 hours over baseline use for a period of 48 hours? Refer to the VIDA Baseline PEF and Rescue Use Values (P1_BASELINE) form. (1010) 1 Yes 0 No (1020) 1 Yes 0 No (Do not complete Q4 at Visits 2 and 3) 4. Did the participant experience prebronchodilator FEV 1 values < 80% of the baseline prebronchodilator value obtained at Visit 3 on two consecutive spirometric determinations made on different days? (1030) 1 Yes 0 No 9 Not evaluated If the participant experienced a prebronchodilator FEV 1 value < 80% of the baseline value obtained at Visit 3, but he/she was not evaluated a second time, select Not Evaluated. 5. Did the study or treating physician prescribe the participant (1040) additional inhaled corticosteroids or oral/parenteral 1 Yes 0 No corticosteroids for the treatment of his/her asthma? If YES, and oral/parenteral corticosteroids or non-study inhaled steroids were used, record them on the Concomitant Medications for Asthma/Allergy and Adverse Events (CMED) form. If YES, and oral/parenteral corticosteroids were used, complete a VIDA Significant Asthma Exacerbation (P1_SIGEX) form. 6. Did the participant require emergency treatment at a (1050) medical facility that was related to, or complicated by, 1 Yes 0 No his/her asthma and that resulted in systemic corticosteroid treatment or hospitalization for an acute asthma exacerbation? If YES, and the participant was hospitalized, complete a Serious Adverse Event Reporting Form (SERIOUS). If YES, and systemic corticosteroid treatment was received, record medications on the Concomitant Medications for Asthma/Allergy and Adverse Events (CMED) form. 05/02/2012 version1.1 Page 1 of 2 *P1_TXFAIL_chk*
3 TREATMENT FAILURE CHECKLIST Part. ID: - - Visit: 7. Did the participant refuse to continue study drugs because of lack of satisfaction with treatment? 8. Based on clinical judgment, did the physician deem this participant a treatment failure for safety reasons? 9. Did the participant experience a significant asthma exacerbation? If YES, complete the VIDA Significant Asthma Exacerbation (P1_SIGEX) form. (1060) 1 Yes 0 No (1070) 1 Yes 0 No (1080) 1 Yes 0 No 10. Did the participant experience a treatment failure? (1090) 1 Yes 0 No If any of the shaded boxes in Q2-Q9 is filled in, the participant experienced a treatment failure. If YES, complete the rest of this form and record the treatment failure on the Clinical Adverse Events (AECLIN) form using ICD-9 code Also, complete a Treatment Failure Information (P1_TXFAIL) form. If NO, STOP HERE and continue with remaining visit procedures. 11. Date treatment failure conditions were met (1100) / / 20 MM DD YYYY COMMENTS: (6000) 05/02/2012 version1.1 Page 2 of 2 *P1_TXFAIL_CHK*
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