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Endpoints - Clinical Trials in Respiratory Diseases - Pulmonary Function Tests, Biomarkers and Quality of Life Questionnaires All Play Prominent Roles
Date:8/27/2012

d effective strategies by clinical phase wise endpoint analysis of clinical trials. This can help in reducing the drug's time to market.

- Exploit strategies for designing of clinical trials by identifying the advantages and disadvantages involved with the use of specific endpoints.

1 Table of Contents1 Table of Contents 51.1 List of Tables 81.2 List of Figures 102 Introduction 133 Clinical Trials Endpoints in Respiratory Diseases - An Overview 143.1 Introduction 143.2 Types of Endpoints 143.2.1 Primary Endpoints 143.2.2 Secondary Endpoints 143.2.3 Surrogate Endpoints 154 Endpoints - Clinical Trials in Asthma - Marketed and Pipeline Products Assessment 164.1 Introduction 164.2 Primary Endpoints Used in Asthma Clinical Trials 204.2.1 Pulmonary Function Tests: 204.2.2 Vital Signs and Physical Activity 204.2.3 Biomarkers 204.2.4 Serious Adverse Events 204.3 Secondary Endpoints Used in Asthma Clinical Trials 214.3.1 Pharmacokinetics and Pharmacodynamics 214.3.2 Quality of Life Scores 214.3.3 Clinical Laboratory Tests – Biochemistry and Serum Hematology 214.3.4 Use of Rescue Medication 214.4 Asthma Therapeutics – Major Marketed Drugs 214.4.1 Singulair (Montekeulast Sodium) 214.4.2 Accolate Accoleit, Vanticon (Zafirlukast) 224.4.3 Zyflo (Zileuton) 234.4.4 Foradil (Formoterol Fumarate Inhalation Powder) 244.4.5 Symbicort (budesonide/formoterol fumarate dihydrate inhalation aerosol) 254.4.6 Xolair (Omalizumab) 274.4.7 Serevent Diskus (Salmaterol Xinafoate Inhalation Powder) 284.4.8 Advair Diskus (Fluticasone Propionate and Salmeterol Inhalation Powder) 294.5 Asthma Therapeutics – Promising Drugs under Clinical Development 304.5.1 Daxas (Roflumilast) (Daxas, APTA 2217, B9302-107, BY 217, BYK 20869) 304.6 Phase III Clinical Trial Analysis 314.6.1 Completed Trial Analysis 314.6.2 Active Trial Analysis 354.6.3 Terminated Trial Analysis 394.7 Phase II Clinical Trial Analysis 414.7.1 Completed Trial Analysis 414.7.2 Active Trial Analysis 454.7.3 Te
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