None listed
Conditions
Interventions
AFTER SIGNING THE INFORMED CONSENT (VISIT 1), PATIENTS WILL BE WEANED ONTO INHALED BUDESONIDE BEGINNING AT THE NEXT VISIT.
ASTHMA PATIENTS WHO ARE ALREADY RECEIVING ICS OR ICS-LABA THERAPY ARE THE
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. MALES AND FEMALES OF ANY RACE WHO ARE BETWEEN 18 AND 65 YEARS OLD AT THE TIME INFORMED CONSENT IS PROVIDED. 2. PHYSICIAN DIAGNOSIS OF ASTHMA, AS PER [GINA] GUIDELINES, AND CURRENTLY PRESCRIBED ICS THERAPY. 3. PATIENTS WITH A PRE-BRONCHODILATOR FEV₁ VALUE OF 40% TO 80% OF INDIVIDUAL PREDICTED VALUE AT SCREENING AND AT RANDOMIZATION, AND THE VALUE AT THE RANDOMIZATION SHOULD BE WITHIN 15% OF THE SCREENING FEV₁. 4. PATIENTS SHOULD BE ALLERGIC OR ATOPIC, AS DIAGNOSED HISTORICALLY OR PRIOR TO ENTRY INTO THE STUDY. 5. PATIENTS WHO ARE DEMONSTRATE TO HAVE REVERSIBLE AIRWAY OBSTRUCTION OR AIRWAYS HYPER-REACTIVITY OR HAVE SHOWN EITHER OF SUCH RESPONSES IN PREVIOUS TEST(S) WITHIN THE LAST 5 YEARS.
Exclusion criteria
Exclusion criteria: 1. USE OF OTHER INVESTIGATIONAL DRUGS AT THE TIME OF ENROLLMENT, OR WITHIN 30 DAYS OR 5 HALF-LIVES OF ENROLLMENT, WHICHEVER IS LONGER. 2. HISTORY OF HYPERSENSITIVITY TO ANY OF THE STUDY DRUGS OR TO DRUGS OF SIMILAR CHEMICAL CLASSES (CRTh2 ANTAGONISTS). 3. HISTORY OF LONG QT SYNDROME OR WHOSE QTc INTERVAL (FRIDERICIA´S) IS PROLONGED > 450 MSEC FOR MALES AND FEMALES AT SCREENING AS ASSESSED BY CENTRAL ECG INTERPRETATION. 4. HISTORY MALIGNANCY OF ANY ORGAN SYSTEM (OTHER THAN LOCALIZED BASAL CELL CARCINOMA OF THE SKIN), TREATED OR UNTREATED, WITHIN THE PAST 5 YEARS, REGARDLESS OF WHETHER THERE IS EVIDENCE OF LOCAL RECURRENCE OR METASTASES. 5. PREGNANT OR NURSING (LACTATING) WOMEN, WHERE PREGNANCY IS DEFINED AS THE STATE OF A FEMALE AFTER CONCEPTION AND NTIL THE TERMINATION OF GESTATION, CONFIRMED BY A POSITIVE hCG LABORATORY TEST (> 5 mIU/mL). 6. WOMEN OF CHILD-BEARING POTENTIAL, DEFINED AS ALL WOMEN PHYSIOLOGICALLY CAPABLE OF BECOMING PREGNANT, MUST USE EFECTIVE CONTRACEPTION DURING THE STUDY AND FOR 5 DAYS (5 HALF-LIVES) AFTER TREATMENT.
Countries
Argentina, Austria, Bulgaria, Canada, Colombia, France, Germany, Greece, Guatemala, Hungary, India, Italy, Japan, Mexico, Netherlands, Peru, Philippines, Poland, Romania, Russian Federation, South Africa, Turkey, United Kindgdom, United States, Venezuela
Contacts
Public ContactAlexandra Lopez
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed