None listed
Conditions
Interventions
PATIENT WILL BE ON TREATMENT WITH INHALED CORTICOIDS AS A CONTROLLER MAINTENANCE THERAPY FOR THEIR ASTHMA DURING THE WHOLE TRIAL.
THE TRIAL DESIGN HAS BEEN SELECTED TO ALLOW ASSESSMENT OF SAFETY AN
Sponsors
Boehringer Ingelheim,
Eligibility
Age
6 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1. ALL PATIENTS´ PARENT(S) (OR LEGAL GUARDIAN) MUST SIGN AND DATE AN INFORMED CONSENT CONSISTENT WITH ICH GCP GUIDELINES AND LOCAL LEGISLATION PRIOR TO PARTICIPATION IN THE TRIAL, I.E. PRIOR TO ANY STUDY PROCEDURES INCLUDING MEDICATION WASH-OUT AND RESTRICTIONS. IN ADDITION, AN INFORMED ASSENT SUITABLE FOR THIS AGE GROUP HAS TO BE OBTAINED FROM PATIENTS. A SEPARATE INFORMED CONSENT/ASSENT IS REQUIRED FOR PHARMACOGENOMIC SAMPLING (CONSENT/ASSENT FOR PHARMACOGENOMIC SAMPLING IS NOT A PREREQUISITE FOR STUDY ENTRY). 2. MALE OR FEMALE PATIENTS BETWEEN 6 AND 11 YEARS OF AGE (AT DAY OF INFORMED CONSENT/ASSENT), 3. ALL PATIENTS MUST HAVE AT LEAST A 6-MONTH HISTORY OF ASTHMA AT THE TIME OF ENROLMENT INTO THE TRIAL. 4. ALL PATIENTS MUST HAVE BEEN ON MAINTENANCE TREATMENT WITH AN INHALED CORTICOSTEROID AT A STABLE MEDIUM DOSE, EITHER AS MONO TREATMENT OR IN COMBINATION WITH ANOTHER CONTROLLER MEDICATION (E.G. A LABA OR A LEUKOTRIENE MODIFIER), FOR AT LEAST 4 WEEKS BEFORE VISIT 1 (SEE TABLE 10.3: 1 IN APPENDIX 10.3 FOR THE DEFINITION OF MEDIUM DAILY DOSE OF INHALED CORTICOSTEROIDS ADAPTED FROM GINA GUIDELINES).
Exclusion criteria
Exclusion criteria: 1. PATIENTS WITH A SIGNIFICANT DISEASE OTHER THAN ASTHMA (E.G. CYSTIC FIBROSIS). A SIGNIFICANT DISEASE IS DEFINED AS A DISEASE WHICH, IN THE OPINION OF THE INVESTIGATOR, MAY (I) PUT THE PATIENT AT RISK BECAUSE OF PARTICIPATION IN THE TRIAL, OR (II) INFLUENCE THE RESULTS OF THE TRIAL, OR (III) CAUSE CONCERN REGARDING THE PATIENT´S ABILITY TO PARTICIPATE IN THE TRIAL. 2. PATIENTS WITH A CLINICALLY RELEVANT ABNORMAL HAEMATOLOGY OR BLOOD CHEMISTRY AT SCREENING, IF THE ABNORMALITY DEFINES A SIGNIFICANT DISEASE AS DEFINED IN EXCLUSION CRITERION N° 1. 3. PATIENTS WITH A HISTORY OF CONGENITAL OR, ACQUIRED HEART DISEASE, OR PATIENTS WHO HAVE BEEN HOSPITALIZED FOR CARDIAC SYNCOPE OR FAILURE DURING THE PAST YEAR 4. PATIENTS WITH ANY UNSTABLE OR LIFE-THREATENING CARDIAC ARRHYTHMIA (IN THE OPINION OF THE INVESTIGATOR) OR CARDIAC ARRHYTHMIA REQUIRING INTERVENTION (E.G. PACEMAKER IMPLANTATION) OR A CHANGE IN DRUG THERAPY WITHIN THE PAST YEAR. 5. PATIENTS WITH A MALIGNANCY FOR WHICH THE PATIENT HAS UNDERGONE RESECTION, RADIATION THERAPY OR CHEMOTHERAPY WITHIN THE LAST FIVE YEARS. 6. PATIENTS WITH KNOWN ACTIVE TUBERCULOSIS. 7. PATIENTS WHO HAVE UNDERGONE THORACOTOMY WITH PULMONARY RESECTION. PATIENTS WITH A HISTORY OF THORACOTOMY FOR OTHER REASONS SHOULD BE EVALUATED AS PER EXCLUSION CRITERION N° 1.
Countries
Bulgaria, Germany, Guatemala, Korea North, Lithuania, Portugal, Romania, Russian Federation, Sweden, Ukraine, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed