A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF 52 WEEKS OF ONCE DAILY TREATMENT OF ORALLY INHALED TIOTROPIUM + OLODATEROL FIXED DOSE COMBINATION (2.5 µG / 5 µG; 5 µG / 5 µG) (DELIVERED BY THE RESPIMAT) COMPARED…
- Registration Number
- PER-089-11
- Lead Sponsor
- Boehringer Ingelheim,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 0
1. ALL PATIENTS MUST SIGN A CONSENT GUIDELINES COMPATIBLE WITH THE ICH GCP BEFORE PARTICIPATING IN THE TEST, WHICH INCLUDES THE WASHING OF DRUGS AND RESTRICTIONS.
2. ALL PATIENTS MUST HAVE A DIAGNOSIS OF COPD [P10-01267] AND MUST MEET THE FOLLOWING CRITERIA SPIROMETRIC:
PATIENTS MUST HAVE AN OBSTRUCTION AIRWAY RELATIVELY STABLE WITH A FEV ₁ POST-BRONCHODILATOR <80% PREDICTED NORMAL (ECSC, [R94-1408]; GOLD II-IV, [P10-01267] AND FEV ₁ POST BRONCHODILATOR / FVC <70% AT VISIT 1
(SEE APPENDIX EQUATIONS 103 TO KNOW THE NORMAL VALUES OF ANTICIPATED ECSC).
3. PATIENTS MEN OR WOMEN, 40 YEARS OF AGE OR OLDER.
4. BE PATIENT OR EX SMOKERS SMOKING TOBACCO BACKGROUND WITH MORE THAN 10 PAQUETES-AÑO. (SEE APPENDIX TO KNOW THE CALCULATIONS 10.3):
PATIENTS NEVER BE EXCLUDED SMOKED CIGARETTES.
5. PATIENTS SHOULD BE CAPABLE OF
• PULMONARY FUNCTION TESTING TECHNICALLY ACCEPTABLE, MAKING MEASUREMENTS FEP TECHNICALLY ACCEPTABLE,
• KEEP RECORDS (DAILY DAILY ELECTRONIC PATIENT) BETWEEN THE STUDY.
1. PATIENTS WITH SIGNIFICANTLY DIFFERENT FROM COPD; SIGNIFICANT ILLNESS IS DEFINED AS A DISEASE IN WHICH, IN THE OPINION OF INVESTIGATOR MAY (i) HAZARDOUS TO PATIENT DUE TO PARTICIPATION IN THE STUDY, (ii) INFLUENCE THE RESULTS STUDY or (iii) GENERATING CAPACITY CONCERNS REGARDING THE PATIENT TO PARTICIPATE IN THE STUDY.
2. PATIENTS IN RESEARCH VIEW, PRESENT VALUES OF HEMATOLOGY, CHEMICAL ANALYSIS OF URINE OR BLOOD STARTED TO BE CLINICALLY SIGNIFICANT UNUSUAL; ALL PATIENTS WITH SGOT> X 2 ULN, SGPT> 2 X ULN BILIRUBIN> ULN or CREATININE X2> X2 BE EXCLUDED LSN REGARDLESS OF CLINICAL CONDITION (NOT REPEAT THE LABORATORY EVALUATION IN THESE PATIENTS).
3. PATIENTS WITH A HISTORY OF ASTHMA. IN THE CASE OF PATIENTS WITH OR ATOPIA ALLERGIC RHINITIS, SOURCE DOCUMENTATION NECESSARY TO VERIFY THAT THE PATIENT NO ASTHMA. IF A PATIENT HAS A TOTAL COUNT BLOOD EOSINOPHILS ≥ 600/mm³ SOURCE DOCUMENTATION NECESSARY TO VERIFY THAT THE INCREASE EOSINOPHILS COUNT IS NOT ASSOCIATED WITH ASTHMA CONDITION.
PATIENTS WITH ANY OF THE FOLLOWING CONDITIONS:
4. DIAGNOSIS OF THYROTOXICOSIS (DUE TO THE PROFILE OF CLASS KNOWN SIDE EFFECTS OF β2 AGONISTS).
5. DIAGNOSIS OF PAROXYSMAL TACHYCARDIA (> JANUARY 00 BEATS PER MINUTE) (DUE TO THE PROFILE OF CLASS KNOWN SIDE EFFECTS OF β₂ AGONISTS).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method