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)

Not Applicable

• Registration Number: PER-079-12
• Lead Sponsor: GENENTECH, INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-14
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 55

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified