None listed
Conditions
Interventions
AFTER SIGNING INFORMED CONSENT (AND OBTAINING ASSENT WHERE APPROPRIATE) AND COMPLETING AN INITIAL SCREENING VISIT, PATIENTS ENTER A 2-WEEK SCREENING PERIOD TO ENSURE CLINICAL STABILITY (I.E. NO EXACER
Sponsors
Boehringer Ingelheim,
Eligibility
Sex/Gender
All
Age
1 Years to 5 Years
Inclusion criteria
Inclusion criteria: 1. ALL PATIENTS´ PARENTS (OR LEGAL GUARDIANS) 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 WASHOUT AND RESTRICTIONS. WHERE APPROPRIATE, PARTICIPANTS SHOULD ASSENT TO ENROL] IN THE STUDY (AGE OF ASSENT TO BE DETERMINED BY IRB´S/LEC´S OR BE CONSISTENT WITH LOCAL LEGAL REQUIREMENTS) (SEE SECTION 8.1). 2. MALE OR FEMALE OUTPATIENTS BETWEEN 1 AND 5 YEARS OF AGE (UP TO 1 DAY PRIOR TO THEIR 6TH BIRTHDAY AT VISIT 1). 3. BY A PHYSICIAN DOCUMENTED (AT LEAST 6 MONTH) HISTORY OF PERSISTENT ASTHMA SYMPTOMS, INCLUDING (BUT NOT LIMITED TO) WHEEZING, COUGH, AND/OR SHORTNESS OF BREATH. (PERSISTENT = NEED FOR ICS MAINTENANCE THERAPY TO CONTROL ASTHMA SYMPTOMS) 4. FOR PATIENTS AGED 5 YEARS AND CAPABLE OF PERFORMING TECHNICALLY ACCEPTABLE PFTS: DOCUMENTED IMPAIRED LUNGFUNCTION (E.G. PRE-BRONCHODILATOR FEVI < 90% OF PREDICTED NORMAL). DOCUMENTATION MAY BE ESTABLISHED AT VISIT 1. 5. ALL PATIENTS MUST HAVE BEEN ON MAINTENANCE TREATMENT WITH AN INHALED CORTICOSTEROID AT A STABLE DOSE, EITHER AS MONO TREATMENT OR IN COMBINATION WITH ANOTHER CONTROLLER MEDICATION, FOR AT LEAST 4 WEEKS BEFORE VISIT 1. PLEASE REFER TO THE GINA GUIDELINE FOR CHILDREN AGED 5 YEARS AND YOUNGER [P11-00966] FOR RECOMMENDED ICS DOSES.
Exclusion criteria
Exclusion criteria: 1. PATIENTS WITH A SIGNIFICANT DISEASE OTHER THAN ASTHMA. 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 CLINICALLY RELEVANT ABNORMAL SCREENING HAEMATOLOGY OR BLOOD CHEMISTRY WILL BE EXCLUDED IF THE ABNORMALITY DEFINES A SIGNIFICANT DISEASE AS DEFINED IN EXCLUSION CRITERION 1. 3. PATIENTS WITH A HISTORY OF CONGENITAL OR ACQUIRED HEART DISEASE, OR PATIENTS WHO HAVE BEEN HOSPITALISED 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), INCLUDING 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. 6. PATIENTS WITH CLINICALLY SIGNIFICANT LUNG DISEASES OTHER THAN ASTHMA, SUCH AS, BUT NOT LIMITED TO, THE FOLLOWING DIAGNOSES: CYSTIC FIBROSIS, VASCULAR RING OR SLING, TRACHEO(BRONCHO)MALACIA, OR BRONCHOPULMONARY DYSPLASIA.
Countries
Belgium, Finland, Germany, Korea North, Lithuania, Malasya, Netherlands, Philippines, Ukraine, United States
Contacts
Public ContactJorge Manuel Timoteo
CIDAL PERU S.A.C.
Outcome results
None listed