A PHASE II/III, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP TRIAL TO EVALUATE SAFETY AND EFFICACY OF TIOTORPIUM INHALATION SOLUTION (2.5 µG AND 5µG) ADMINISTERED ONCE DAILY IN THE AFTERNOON VIA RESPIMAT® INHALER FOR 12 WEEKS INPATIENTS 1 TO 5 YEARS OLD WITH PERSISTENT ASTHMA.

Boehringer Ingelheim,0 个研究点目标入组 0 人开始时间: 2012年12月14日最近更新: 2023年9月4日

试验速览

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•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.

•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.

发起方

Boehringer Ingelheim,