None listed
Conditions
Interventions
THE STUDY CONSISTIS OF A 2- TO 4-WEEK SCREENING PERIOD, AND A 52-WEEK DOUBLE-BLIND TREATMENT PERIOD, INCLUDING A FINAL EVALUATION AT WEEK 52 (4 WEEKS AFTER THE FINAL INFUSION AT WEEK 48).
PRIOR TO
MEASURED AND THEN REPEATING FEV₁
MEASUREMENT AFTER RECEIVING SHORT-ACTING BETA-AGONIST THERAPY IF A PATIENT´S FEV₁
IMPROVES AT LEAST 12 % BETWEEN THE 2 TESTS, THAT PATIENT WILL BE DEEMED AS HAVING AIRWAY REVERSIBILITY AND WILL CONTINUE THE SCREENING PROCESS. THE PATIENTS WILL ALSO BE ASKED ABOUT THEIR ASTHMA MEDIC
Sponsors
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D,
Eligibility
Age
12 Years to 75 Years
Inclusion criteria
Inclusion criteria: (A) THE PATIENT IS MALE OR FEMALE, THROUGH 75 YEARS OF AGE, WITH A PREVIOUS DIAGNOSIS OF ASTHMA. (B) THE PATIENT HAS HAD AT LEAST 1 ASTHMA EXACERBATION REQUIRING ORAL IV CORTICOSTEROID USE FOR AT LEAST 3 DAYS OVER THE PAST 12 MONTHS BEFORE SCREENING. (C) THE PATIENT HAS A CURRENT BLOOD EOSINOPHIL OF AT LEAST 400/µL. (D) THE PATIENT HAS AIRWAY REVERSIBILITY OF AT LEAST 12% TO BETA-AGONIST ADMINISTRATION. (E) THE PATIENT HAS AN ACQ SCORE OF AT LEAST 1.5. (F) THE PATIENT IS TAKING INHALED FLUTICASONE AT A DOSAGE OF AT LEAST 440 µG, OR EQUIVALENT, DAILY. CHRONIC ORAL CORTICOSTEROID USE (NO MORE THAN 10 MG/DAY PREDNISONE OR EQUIVALENT) IS ALLOWED. IF A PATIENT IS ON A STABLE DOSE, eg, 2 WEEKS OR MORE of ORAL CORTICOSTEROID TREATMENT AT THE TIME OF STUDY ENROLLMENT, THE PATIENT MUST REMAIN ON THIS DOSE THROUGHOUT THE STUDY. (G) ALL FEMALE PATIENTS MUST BE SURGICALLY STERILE, 2 YEARS POSTMENOPAUSAL, OR MUST HAVE A NEGATIVE PREGNANCY TEST β-HCG AT SCREENING (SERUM) AND BASELINE (URINE).
Exclusion criteria
Exclusion criteria: (A) THE PATIENT HAS A CLINICALLY MEANINGFUL COMORBIDITY THAT WOULD INTERFERE WITH THE STUDY SCHEDULE OR PROCEDURES, OR COMPROMISE THE PATIENT´S SAFETY. (B)THE PATIENT HAS KNOWN HYPEREOSINOPHILIC SYNDROME. (C)THE PATIENT HAS ANOTHER CONFOUNDING UNDERLYING LUNG DISORDER (eg, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, PULMONARY FIBROSIS, OR LUNG CANCER). (D)THE PATIENT IS A CURRENT SMOKER (ie, HAS SMOKED WITHIN THE LAST 6 MONTHS PRIOR TO THE SCREENING). (E) THE PATIENT IS USING SYSTEMIC IMMUNOSUPPRESSIVE OR IMMUNOMODULATING DRUGS, eg, SYSTEMIC CORTICOSTEROIDS GREATER THAN 10 MG/DAY DAILY DOSE, METHOTREXATE, CYCLOSPORINE OR ANTIBODY 6 MONTHS PRIOR TO STUDY ENTRY (RANDOMIZATION). (F) THE PATIENT HAS PARTICIPATED IN AN ANTI-IL-5 STUDY FOR ASTHMA. (G) THE PATIENT HAS ANY AGGRAVATING MEDICAL FACTORS THAT ARE INADEQUATELY CONTROLLED (eg, RHINITIS OR GASTROESOPHAGEAL REFLUX DISEASE). (H) THE PATIENT HAS PARTICIPATED ANY INVESTIGATVE DRUG OR DEVICE STUDY WITHIN 30 DAYS PRIOR TO THE STUDY ENROLLMENT (RANDOMIZATION). (I) THE PATIENT HAS PARTICIPATED IN ANY INVESTIGATIVE BIOLOGICS STUDY WITHIN 3 MONTHS PRIOR TO STUDY ENROLLMENT (RANDOMIZATION).
Countries
Argentina, Brazil, Canada, France, Germany, Greece, India, Korea North, Mexico, Peru, Romania, Russian Federation, Slovakia, Taiwan, Ukraine, United States
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed