None listed
Conditions
Interventions
THE STUDY CONSIST OF A SCREENING/BASELINE VISIT FOLLOWED BY AN OPEN-LABEL TREATMENT PERIOD, AN END-OF-TREATMENT VISIT CONDUCTED 4 WEEKS AFTER THE LAST DOSE OF RESLIZUMAB, AND A 90-DAY FOLLOW-UP EVALU
Sponsors
Cephalon, Inc.,
Eligibility
Age
12 Years to 75 Years
Inclusion criteria
Inclusion criteria: (A) THE PATIENT IS MALE OR FEMALE, 12 THROUGH 75 YEARS OF AGE, WITH A PREVIOUS DIAGNOSIS OF ASTHMA. PATIENTS 12 THROUGH 17 YEARS OLD ARE EXCLUDED FROM PARTICIPATING IN INDIA AND ARGENTINA; PATIENTS 66 THROUGH 75 YEARS OF AGE ARE EXCLUDED FROM PARTICIPATING IN INDIA. (B) WRITTEN INFORMED CONSENT IS OBTAINED. PATIENTS 12 THROUGH 17 YEARS OLD, WHERE PARTICIPATING, NEED TO PROVIDE ASSENT IN ACCORDANCE WITH LOCAL STANDARDS. (C) PATIENT MUST HAVE COMPLETED TREATMENT IN A PREVIOUS CEPHALON-SPONSORED DOUBLE-BLIND ASTHMA EXACERBATION STUDY OR RECEIVED AT LEAST 2 DOSES OF STUDY DRUG TREATMENT IN A PULMONARY FUNCTION STUDY. (D) THE PATIENT MUST BE WILLING AND ABLE TO COMPLY WITH STUDY RESTRICTIONS AND TO REMAIN AT THE CLINIC FOR THE REQUIRED DURATION DURING THE STUDY PERIOD, AND WILLING TO RETURN TO THE CLINIC FOR THE FOLLOW-UP EVALUATION AS SPECIFIED IN THIS PROTOCOL.
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 CONFOUNDING UNDERLYING LUNG DISORDER (e.g., CHRONIC OBSTRUCTIVE PULMONARY DISEASE, PULMONARY FIBROSIS, OR LUNG CANCER). (C) THE PATIENT IS CURRENT SMOKER. (D) THE PATIENT IS EXPECTED TO BE POORLY COMPLIANT WITH STUDY DRUG ADMINISTRATION, STUDY PROCEDURES, OR VISITS. (E) THE PATIENT HAS ANY AGGRAVATING FACTORS THAT ARE INADEQUATELY CONTROLLED (e.g., GASTROESOPHAGEAL REFLUX DISEASE [GERD]). (F) FEMALE PATIENTS OF CHILDBEARING POTENTIAL (NOT SURGICALLY STERILE OR 2 YEARS POSTMENOPAUSAL), MUST USE A MEDICALLY ACCEPTED METHOD OF CONTRACEPTION AND MUST AGREE TO CONTINUE USE OF THIS METHOD FOR THE DURATION OF THE STUDY AND FOR 30 DAYS AFTER THE END-OF-TREATMENT VISIT. ACCEPTABLE METHODS OF CONTRACEPTION INCLUDE BARRIER METHOD WITH SPERMICIDE, ABSTINENCE, INTRAUTERINE DEVICE (IUD), OR STEROIDAL CONTRACEPTIVE (ORAL, TRANSDERMAL, IMPLANTED, AND INJECTED). (G) THE PATIENT HAS A CURRENT INFECTION OR DISEASE THAT MAY PRECLUDE ASSESSMENT OF ASTHMA.
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Korea South, Malasya, Mexico, Netherlands, New Zealand, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Sweden, Taiwan, Thailand, Ukraine, United States
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed