Sections
Title | Starting Page | Number of Pages |
---|
Table of Contents | 5 | 8 |
List of Tables | 8 | 2 |
List of Figures | 10 | 3 |
Introduction | 13 | 1 |
Clinical Trials Endpoints in Respiratory Diseases - An Overview | 14 | 2 |
Introduction | 14 | 1 |
Types of Endpoints | 14 | 1 |
Primary Endpoints | 14 | 1 |
Secondary Endpoints | 14 | 1 |
Surrogate Endpoints | 15 | 1 |
Endpoints - Clinical Trials in Asthma - Marketed and Pipeline Products Assessment | 16 | 60 |
Introduction | 16 | 4 |
Primary Endpoints Used in Asthma Clinical Trials | 20 | 1 |
Pulmonary Function Tests: | 20 | 1 |
Vital Signs and Physical Activity | 20 | 1 |
Biomarkers | 20 | 1 |
Serious Adverse Events | 20 | 1 |
Secondary Endpoints Used in Asthma Clinical Trials | 21 | 1 |
Pharmacokinetics and Pharmacodynamics | 21 | 1 |
Quality of Life Scores | 21 | 1 |
Clinical Laboratory Tests Biochemistry and Serum Hematology | 21 | 1 |
Use of Rescue Medication | 21 | 1 |
Asthma Therapeutics Major Marketed Drugs | 21 | 1 |
Singulair (Montekeulast Sodium) | 21 | 1 |
Overview | 21 | 1 |
Efficacy | 21 | 1 |
Safety | 21 | 1 |
Clinical Study Details | 22 | 1 |
Accolate Accoleit, Vanticon (Zafirlukast) | 22 | 1 |
Overview | 22 | 1 |
Efficacy | 22 | 1 |
Safety | 23 | 1 |
Clinical Study Details | 23 | 1 |
Zyflo (Zileuton) | 23 | 1 |
Overview | 23 | 1 |
Efficacy | 23 | 1 |
Safety | 23 | 1 |
Clinical Study Details | 24 | 1 |
Foradil (Formoterol Fumarate Inhalation Powder) | 24 | 1 |
Overview | 24 | 1 |
Efficacy | 24 | 1 |
Safety | 24 | 1 |
Clinical Study Details | 25 | 1 |
Symbicort (budesonide/formoterol fumarate dihydrate inhalation aerosol) | 25 | 1 |
Overview | 25 | 1 |
Efficacy | 26 | 1 |
Safety | 26 | 1 |
Clinical Study Details | 26 | 1 |
Xolair (Omalizumab) | 27 | 1 |
Overview | 27 | 1 |
Efficacy | 27 | 1 |
Safety | 27 | 1 |
Clinical Study Details | 27 | 1 |
Serevent Diskus (Salmaterol Xinafoate Inhalation Powder) | 28 | 1 |
Overview | 28 | 1 |
Efficacy | 28 | 1 |
Safety | 29 | 1 |
Clinical Study Details | 29 | 1 |
Advair Diskus (Fluticasone Propionate and Salmeterol Inhalation Powder) | 29 | 1 |
Overview | 29 | 1 |
Efficacy | 29 | 1 |
Safety | 29 | 1 |
Clinical Study Details | 30 | 1 |
Asthma Therapeutics Promising Drugs under Clinical Development | 30 | 1 |
Daxas (Roflumilast) (Daxas, APTA 2217, B9302-107, BY 217, BYK 20869) | 30 | 1 |
Overview | 30 | 1 |
Efficacy | 30 | 1 |
Safety | 30 | 1 |
Clinical Study Details | 31 | 1 |
Phase III Clinical Trial Analysis | 31 | 1 |
Completed Trial Analysis | 31 | 4 |
Active Trial Analysis | 35 | 4 |
Terminated Trial Analysis | 39 | 2 |
Phase II Clinical Trial Analysis | 41 | 1 |
Completed Trial Analysis | 41 | 4 |
Active Trial Analysis | 45 | 4 |
Terminated Trial Analysis | 49 | 27 |
Endpoints - Clinical Trials in Chronic Obstructive Pulmonary Disorder - Marketed and Pipeline Products Assessment | 76 | 49 |
Introduction | 76 | 4 |
Primary Endpoints Used in COPD Clinical Trials | 80 | 1 |
Pulmonary Function Tests | 80 | 1 |
Baseline Dyspnea Index and Borg-Dyspnea Score | 80 | 1 |
Rate of Exacerbations | 80 | 1 |
Induced Sputum Analysis | 80 | 1 |
Biomarkers of COPD | 80 | 1 |
Secondary Endpoints Used in COPD Clinical Trials | 80 | 1 |
Exercise Endurance Time | 80 | 1 |
Serum Hematology | 80 | 1 |
Six Minute Walk Distance | 80 | 1 |
Time to First Exacerbation | 81 | 1 |
COPD Therapeutics Major Marketed Drugs | 81 | 1 |
Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder) | 81 | 1 |
Overview | 81 | 1 |
Efficacy | 81 | 1 |
Safety | 81 | 1 |
Clinical Study Details | 81 | 1 |
Brovana (Arformoterol) | 82 | 1 |
Overview | 82 | 1 |
Efficacy | 82 | 1 |
Safety | 82 | 1 |
Clinical Study Details | 82 | 1 |
Foradil Aerolizer (Formoterol Fumarate Inhalation Powder) | 83 | 1 |
Overview | 83 | 1 |
Efficacy | 83 | 1 |
Safety | 83 | 1 |
Clinical Study Details | 83 | 1 |
Symbicort (Budesonide/Formoterol Fumarate Dihydrate) | 84 | 1 |
Overview | 84 | 1 |
Efficacy | 84 | 1 |
Safety | 84 | 1 |
Clinical Study Details | 84 | 1 |
Advair Diskus (Fluticasone Propionate and Salmeterol Inhalation Powder) | 85 | 1 |
Overview | 85 | 1 |
Efficacy | 85 | 1 |
Safety | 85 | 1 |
Clinical Study Details | 85 | 2 |
Daxas (roflumilast) | 87 | 1 |
Overview | 87 | 1 |
Efficacy | 87 | 1 |
Safety | 87 | 1 |
Clinical Study Details | 87 | 1 |
COPD Therapeutics Promising Drugs Under Clinical Development | 88 | 1 |
Aclidinium Bromide | 88 | 1 |
Overview | 88 | 1 |
Efficacy | 88 | 1 |
Safety | 88 | 1 |
Clinical Study Details | 88 | 1 |
NVA237 (Glycopyrronium Bromide) | 89 | 1 |
Overview | 89 | 1 |
Efficacy | 89 | 1 |
Safety | 89 | 1 |
Clinical Study Details | 89 | 1 |
Dulera | 89 | 1 |
Overview | 89 | 1 |
Clinical Study Details | 90 | 1 |
Phase III Clinical Trial Analysis | 90 | 1 |
Completed Trial Analysis | 90 | 4 |
Active Trials Analysis | 94 | 4 |
Terminated Trial Analysis | 98 | 2 |
Phase II Clinical Trial Analysis | 100 | 1 |
Completed Trial Analysis | 100 | 4 |
Active Trial Analysis | 104 | 3 |
Terminated Trial Analysis | 107 | 18 |
Endpoints - Clinical Trials in Cystic Fibrosis - Marketed and Pipeline Products Assessment | 125 | 31 |
Introduction | 125 | 4 |
Primary Endpoints Used in Cystic Fibrosis Clinical Trials | 129 | 1 |
Coefficient of Fat Absorption | 129 | 1 |
Lung Microbiology | 129 | 1 |
Biomarkers | 129 | 1 |
Secondary Endpoints Used in Cystic Fibrosis Clinical Trials | 129 | 1 |
Nasal Potential Difference | 129 | 1 |
Sweat Chloride Concentration | 129 | 1 |
Cystic Fibrosis Therapeutics Major Marketed Drugs | 129 | 1 |
Tobi (Tobramycin Inhalation Solution) | 129 | 1 |
Overview | 129 | 1 |
Efficacy | 130 | 1 |
Safety | 130 | 1 |
Clinical Study Details | 130 | 1 |
Pulmozyme (Dornase Alfa) | 130 | 1 |
Overview | 130 | 1 |
Efficacy | 131 | 1 |
Safety | 131 | 1 |
Clinical Study Details | 131 | 1 |
Cayston (aztreonam for Inhalation Solution) | 131 | 1 |
Overview | 131 | 1 |
Efficacy | 131 | 1 |
Safety | 132 | 1 |
Clinical Study Details | 132 | 1 |
Colistimethate sodium (Colistin, Colomycin Injection, Promixin, Coly-Mycin M) | 132 | 1 |
Overview | 132 | 1 |
Efficacy | 132 | 1 |
Safety | 133 | 1 |
Cystic Fibrosis Promising Drugs Under Clinical Development | 133 | 1 |
Denufosol Tetrasodium Inhalation Solution (INS37217) | 133 | 1 |
Overview | 133 | 1 |
Efficacy | 133 | 1 |
Safety | 133 | 1 |
Clinical Study Details | 133 | 1 |
VX-770 | 134 | 1 |
Overview | 134 | 1 |
Efficacy | 134 | 1 |
Safety | 134 | 1 |
Clinical Study Details | 134 | 1 |
Bronchitol | 134 | 1 |
Overview | 134 | 1 |
Efficacy | 134 | 1 |
Safety | 135 | 1 |
Clinical Study Details | 135 | 1 |
Ataluren (PTC-124) | 135 | 1 |
Overview | 135 | 1 |
Efficacy | 135 | 1 |
Safety | 135 | 1 |
Clinical Study Details | 135 | 1 |
Phase III Clinical Trial Analysis | 136 | 1 |
Completed Trial Analysis | 136 | 2 |
Active Trial Analysis | 138 | 3 |
Terminated Trial Analysis | 141 | 2 |
Phase II Clinical Trial Analysis | 143 | 1 |
Completed Trial Analysis | 143 | 3 |
Active Trial Analysis | 146 | 3 |
Terminated Trial Analysis | 149 | 7 |
Endpoints - Clinical Trials in Pulmonary Arterial Hypertension - Marketed and Pipeline Products Assessment | 156 | 31 |
Introduction | 156 | 1 |
Classification of Pulmonary Hypertension | 156 | 5 |
Primary Endpoints Used in Pulmonary Hypertension Trials | 161 | 1 |
Cardiopulmonary Hemodynamic Test | 161 | 1 |
Six Minutes Walking Distance | 161 | 1 |
Biomarkers | 161 | 1 |
Secondary Endpoints Used in Pulmonary Hypertension Trials | 161 | 1 |
Time to Clinical Worsening | 161 | 1 |
SF-36 Health Survey | 161 | 1 |
Pulmonary Arterial Hypertension Major Marketed Drugs | 161 | 1 |
Tracleer | 161 | 1 |
Overview | 161 | 1 |
Efficacy | 161 | 1 |
Safety Profile | 162 | 1 |
Clinical Study Details | 162 | 1 |
Remodulin | 162 | 1 |
Overview | 162 | 1 |
Efficacy | 162 | 1 |
Safety | 162 | 1 |
Clinical Study Details | 163 | 1 |
Revatio | 163 | 1 |
Overview | 163 | 1 |
Efficacy | 163 | 1 |
Safety | 163 | 1 |
Clinical Study Details | 163 | 1 |
Ventavis | 164 | 1 |
Overview | 164 | 1 |
Safety | 164 | 1 |
Clinical Study Details | 164 | 1 |
Letairis | 165 | 1 |
Overview | 165 | 1 |
Efficacy | 165 | 1 |
Safety | 165 | 1 |
Clinical Study Details | 165 | 1 |
Adcirca | 166 | 1 |
Overview | 166 | 1 |
Efficacy | 166 | 1 |
Safety | 166 | 1 |
Clinical Study Details | 166 | 1 |
Pulmonary Arterial Hypertension Promising Drugs under Clinical Development | 167 | 1 |
ACT-064992 | 167 | 1 |
Overview | 167 | 1 |
Efficacy | 167 | 1 |
Safety | 167 | 1 |
Clinical Study Details | 167 | 1 |
Oral Treprostinil | 168 | 1 |
Overview | 168 | 1 |
Efficacy | 168 | 1 |