A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND DOSING REGIMENS OF MEMP 1972A IN ADULTS WITH ALLERGIC ASTHMA WHO ARE INADEQUATELY CONTROLLED ON INHALED CORTICOSTEROIDS AND A SECOND CONTROLLER (COSTA)

GENENTECH, INC.,0 个研究点目标入组 55 人开始时间: 2013年1月14日最近更新: 2023年9月4日

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•1. SIGNED INFORMED CONSENT FORM
•2. ABLE AND WILLING TO COMPLY WITH THE STUDY PROOCOL REQUIREMENTS
•3. AGE ≥ 18 AND ≤ 75 YEARS AT VISIT 1
•4. BODY WEIGHT ≥ 40 KG AT VISIT 1
•5. CHEST RADIOGRAPHIC STUDY (CHEST X-RAY, ANTERO-POSTERIOR) WITHIN 12 MONTHS OF VISIT 1 WITH NO EVIDENCE OF CLINICALLY SIGNIFICANT ABNORMALITY OTHER THAN ASTHMA
•6. PHYSICIAN’S DIAGNOSIS OF ASTHMA FOR AT LEAST 12 MONTHS
•7. EVIDENCE OF DOCUMENTED BRONCHODITALATOR REVERSIBILITY DEFINED BY EITHER: 12 % OR GREATER β-AGONIST REVERSIBILITY USING 4 PUFFS SABA (AT SCREENING OR WITHIN LAST 2 YEARS), OR PC20 FEV1 METHACHOLINE (PROVOCATIVE CONCENTRATION OF METHACHOLINE PRODUCING A 20 % FALL IN FEV1) 8 MG/ML OR LESS (WITHIN LAST 2 YEARS)
•8. PREBRONCHODILATORFEV1 ≥ 40 % AND ≤ 80 % PREDICTED AT VISIT 1 (SEE PROCEDURE MANUAL FOR CALCULATION OF % PREDICTED)
•9. REQUIRED DAILY USE OF ICS (≥ 400 µG/DAY TOTAL DAILY DOSE OF FP OR EQUIVALENT, SEE APPENDIX D) AND SECOND CONTROLLER FOR A MINIMUM OF 3 CONSECUTIVE MONTHS PRIOR TO VISIT 1
•10. HISTORY OF AT LEAST ONE PROTOCOL-DEFINED ASTHMA EXACERBATION IN THE 18 MONTHS PRIOR TO VISIT 1 (SEE APPENDIX C FOR DETAILS)

•1. ASTHMA EXACERBATION REQUIRING SYSTEMIC STEROIDS IN THE 30 DAYS PRIOR TO VISIT 1 OR BETWEEN VISIT 1 AND VISIT 2
•2. 20 % RELATIVE CHANGE IN FEV1 BETWEEN VISIT 1 AND VISIT 2
•3. FAILED SCREENING FOR THIS STUDY MORE THAN ONCE
•. PATIENTS MAY RESCREEN ONE TIME IF THE REASON FOR SCREEN FAILURE IS TRANSIENT
•4. HAVE PRE-EXISTING ACTIVE LUNG DISEASE OTHER THAN ASTHMA
•5. ANY INFECTION INCLUDING CHRONIC OR LATENT INFECTIONS OR INFECTIONS REQUIRING TREATMENT DURING SCREENING
•. THIS INCLUDES RESPIRATORY TRACT INFECTIONS (INCLUDING, BUT NOT LIMITED, TO SINUS DISEASE AND BRONCHITIS)
•6, CLINICALLY SIGNIFICANT MEDICAL DISEASE THAT IS UNCONTROLLED DESPITE TREATMENT OR IS LIKELY TO REQUIRE A CHANGE IN THERAPY DURING THE STUDY OR IS OF UNKNOWN ETIOLOGY (E.G., CHRONIC LIVER DISEASE)
•. THIS INCLUDES CHRONIC DISEASES THAT MAY EXACERBATE(E.G., INFLAMMATORY BOWEL DISEASE OR RHEUMATOID ARTHRITIS)
•. THIS INCLUDES A KNOWN MALIGNANCY (NEWLY DIAGNOSED OR INADEQUATELY TREATED) OR CURRENT EVALUATION FOR A POTENCIAL MALIGNANCY
•. THIS INCLUDES KNOWN IMMUNODEFICIENCY, INCLUDING BUT NOT LIMIT ED TO HIV INFECTION, REGARDLESS OF TREATMENT STATUS

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