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Endpoints - Clinical Trials in Respiratory Diseases - Pulmonary Function Tests, Biomarkers and Quality of Life Questionnaires All Play Prominent Roles

Executive Summary

Standardized Clinical Trials Endpoints to Help Health Authorities Tackle Respiratory Diseases.

We all know that smoking and some allergies are bad for our lungs, but now science is standardizing the way that we measure respiratory health, helping to judge the effectiveness of drug treatments better than ever, according to a new report by healthcare experts GBI Research.

The new report* shows that asthma and chronic obstructive pulmonary disorder (COPD), common conditions causing breathing difficulties, are now being studied using a set of common clinical endpoints, which help to standardize test results and draw conclusions regarding the effectiveness of new drugs.

COPD is cited as the fourth most common cause of death in the US by the National Institute of Health, representing a collection of progressive lung diseases including emphysema and chronic bronchitis, often caused by smoking, and is proving a heavy economic burden for state healthcare. Therefore, is has been imperative for health authorities to further improve on their endpoint measurements in order to compare the available treatment options for these disorders.

Clinical trial endpoints are used to measure the outcomes of medical testing, assessing the effects of new treatments. Endpoints in respiratory disease clinical trials should be accurate, precise, easily measurable and reliable, and range from techniques such as daily symptoms scoring, use of rescue medication and the quality of life score, to more specific vital signs such as measuring pulmonary function, respiratory rate and pulse.

The endpoints used in respiratory clinical trials are often chosen depending on the developmental stage of the molecule being studied, as agencies require Phase III trials to study direct clinical endpoints in order to grant drug approvals.

Physicians confirm diagnoses of asthma using pulmonary function tests (PFT), and classify the condition based on Peak Expiratory Flow (PEF) rate, frequency of symptoms and Forced Expiratory Volume (FEV). It is therefore not surprising that FEV was used in 29.9% of completed Phase III clinical trials for asthma products as a primary endpoint during 2000-2010, while another 29.3% of these trials used multiple PFT as a secondary endpoint.

Similarly, 49.2% of phase III COPD clinical trials during 2000-010 used FEV as a primary endpoint, while 20.3% used multiple PFTs as endpoints. PFTs were employed as a primary endpoint in 64 completed clinical trials for asthma and COPD.

Endpoints - Clinical Trials in Respiratory Diseases - Pulmonary Function Tests, Biomarkers and Quality of Life Questionnaires All Play Prominent Roles

This report presents the use of endpoints or outcome measures in respiratory disease's clinical trials for asthma, cystic fibrosis, chronic obstructive pulmonary disorder and pulmonary arterial hypertension. Detailed analysis about the clinical and surrogate endpoint used in various phases and stages of clinical trials are presented. This report presents detailed overview about the endpoint used in major marketed drugs and most promising molecules under development. It also contains company profiles of major companies involved with marketing of major marketed drugs under respiratory drug franchise.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research's team of industry experts.

Abstract

Endpoints - Clinical Trials in Respiratory Diseases - Pulmonary Function Tests, Biomarkers and Quality of Life Questionnaires All Play Prominent Roles

Summary

GBI Research in its report "Endpoints - Clinical Trials in Respiratory Diseases - Pulmonary Function Tests, Biomarkers and Quality of Life Questionnaires All Play Prominent Roles" presents the use of endpoints or outcomes measures in respiratory disease's clinical trials. In this report, endpoint used in asthma, cystic fibrosis, chronic obstructive pulmonary disorder and pulmonary arterial hypertension are presented. In this report detailed analysis about the clinical and surrogate endpoint used in various phases and stages of clinical trials are presented. This report presents detailed overview about the endpoint used in major marketed drugs and most promising molecules under development. The report contains company profiles of major companies involved with marketing of major marketed drugs under respiratory drug franchise.

Scope

  • The report starts with an executive summary, providing insights about the prominent endpoint used in respiratory clinical trials.
  • This report deals with different types of endpoint used in respiratory clinical trials. It contains brief account of advantages, disadvantages and regulatory aspects of each type of endpoint.
  • This report provides in-depth analysis of clinical trial endpoints used in asthma, COPD, cystic fibrosis and PAH clinical trials.
  • This report covers complete account of primary and secondary endpoints used in Phase III and Phase II clinical trials in above mentioned respiratory diseases.
  • In this report characterization and segmentation of trials based on their status, along with specific use of endpoints is also provided.
  • This report provides profiling of major marketed drugs based on their safety, efficacy and clinical study details.
  • The report contains company profiling of major companies associated with marketing of major respiratory drugs covering asthma, COPD, cystic fibrosis and PAH.
  • This report also includes endpoint analysis of terminated trials for asthma, COPD, cystic fibrosis and PAH. Analysis of terminated trials can be used in designing more robust trials and avoid any issues, which can result in termination of trial.

Reasons to buy

  • Understand the pattern of use of primary and secondary endpoints, according to specific indication's and clinical Phase of trial. This will help in designing clinical trials so as to and protect one's product from confronting any of the safety issues.
  • To analyze the major primary and secondary endpoint used in disease specific clinical trials.
  • Reinforce R&D strategies by identifying new endpoints to be used in disease and clinical phase specific clinical trials. This can increase positive outcome from a trial and aid in bringing molecules with increased efficiency and better safety profiles.
  • Develop key strategic initiatives by understanding the key focus of major companies developing drugs in respiratory franchise.
  • Build 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.

TOC

1 Table of Contents

1 Table of Contents 5

  • 1.1 List of Tables 8
  • 1.2 List of Figures 10

2 Introduction 13

3 Clinical Trials Endpoints in Respiratory Diseases - An Overview 14

  • 3.1 Introduction 14
  • 3.2 Types of Endpoints 14
    • 3.2.1 Primary Endpoints 14
    • 3.2.2 Secondary Endpoints 14
    • 3.2.3 Surrogate Endpoints 15

4 Endpoints - Clinical Trials in Asthma - Marketed and Pipeline Products Assessment 16

  • 4.1 Introduction 16
  • 4.2 Primary Endpoints Used in Asthma Clinical Trials 20
    • 4.2.1 Pulmonary Function Tests: 20
    • 4.2.2 Vital Signs and Physical Activity 20
    • 4.2.3 Biomarkers 20
    • 4.2.4 Serious Adverse Events 20
  • 4.3 Secondary Endpoints Used in Asthma Clinical Trials 21
    • 4.3.1 Pharmacokinetics and Pharmacodynamics 21
    • 4.3.2 Quality of Life Scores 21
    • 4.3.3 Clinical Laboratory Tests - Biochemistry and Serum Hematology 21
    • 4.3.4 Use of Rescue Medication 21
  • 4.4 Asthma Therapeutics - Major Marketed Drugs 21
    • 4.4.1 Singulair (Montekeulast Sodium) 21
    • 4.4.2 Accolate Accoleit, Vanticon (Zafirlukast) 22
    • 4.4.3 Zyflo (Zileuton) 23
    • 4.4.4 Foradil (Formoterol Fumarate Inhalation Powder) 24
    • 4.4.5 Symbicort (budesonide/formoterol fumarate dihydrate inhalation aerosol) 25
    • 4.4.6 Xolair (Omalizumab) 27
    • 4.4.7 Serevent Diskus (Salmaterol Xinafoate Inhalation Powder) 28
    • 4.4.8 Advair Diskus (Fluticasone Propionate and Salmeterol Inhalation Powder) 29
  • 4.5 Asthma Therapeutics - Promising Drugs under Clinical Development 30
    • 4.5.1 Daxas (Roflumilast) (Daxas, APTA 2217, B9302-107, BY 217, BYK 20869) 30
  • 4.6 Phase III Clinical Trial Analysis 31
    • 4.6.1 Completed Trial Analysis 31
    • 4.6.2 Active Trial Analysis 35
    • 4.6.3 Terminated Trial Analysis 39
  • 4.7 Phase II Clinical Trial Analysis 41
    • 4.7.1 Completed Trial Analysis 41
    • 4.7.2 Active Trial Analysis 45
    • 4.7.3 Terminated Trial Analysis 49

5 Endpoints - Clinical Trials in Chronic Obstructive Pulmonary Disorder - Marketed and Pipeline Products Assessment 76

  • 5.1 Introduction 76
  • 5.2 Primary Endpoints Used in COPD Clinical Trials 80
    • 5.2.1 Pulmonary Function Tests 80
    • 5.2.2 Baseline Dyspnea Index and Borg-Dyspnea Score 80
    • 5.2.3 Rate of Exacerbations 80
    • 5.2.4 Induced Sputum Analysis 80
    • 5.2.5 Biomarkers of COPD 80
  • 5.3 Secondary Endpoints Used in COPD Clinical Trials 80
    • 5.3.1 Exercise Endurance Time 80
    • 5.3.2 Serum Hematology 80
    • 5.3.3 Six Minute Walk Distance 80
    • 5.3.4 Time to First Exacerbation 81
  • 5.4 COPD Therapeutics - Major Marketed Drugs 81
    • 5.4.1 Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder) 81
    • 5.4.2 Brovana (Arformoterol) 82
    • 5.4.3 Foradil Aerolizer (Formoterol Fumarate Inhalation Powder) 83
    • 5.4.4 Symbicort (Budesonide/Formoterol Fumarate Dihydrate) 84
    • 5.4.5 Advair Diskus (Fluticasone Propionate and Salmeterol Inhalation Powder) 85
    • 5.4.6 Daxas (roflumilast) 87
  • 5.5 COPD Therapeutics - Promising Drugs Under Clinical Development 88
    • 5.5.1 Aclidinium Bromide 88
    • 5.5.2 NVA237 (Glycopyrronium Bromide) 89
    • 5.5.3 Dulera 89
  • 5.6 Phase III Clinical Trial Analysis 90
    • 5.6.1 Completed Trial Analysis 90
    • 5.6.2 Active Trials Analysis 94
    • 5.6.3 Terminated Trial Analysis 98
  • 5.7 Phase II Clinical Trial Analysis 100
    • 5.7.1 Completed Trial Analysis 100
    • 5.7.2 Active Trial Analysis 104
    • 5.7.3 Terminated Trial Analysis 107

6 Endpoints - Clinical Trials in Cystic Fibrosis - Marketed and Pipeline Products Assessment 125

  • 6.1 Introduction 125
  • 6.2 Primary Endpoints Used in Cystic Fibrosis Clinical Trials 129
    • 6.2.1 Coefficient of Fat Absorption 129
    • 6.2.2 Lung Microbiology 129
    • 6.2.3 Biomarkers 129
  • 6.3 Secondary Endpoints Used in Cystic Fibrosis Clinical Trials 129
    • 6.3.1 Nasal Potential Difference 129
    • 6.3.2 Sweat Chloride Concentration 129
  • 6.4 Cystic Fibrosis Therapeutics - Major Marketed Drugs 129
    • 6.4.1 Tobi (Tobramycin Inhalation Solution) 129
    • 6.4.2 Pulmozyme (Dornase Alfa) 130
    • 6.4.3 Cayston (aztreonam for Inhalation Solution) 131
    • 6.4.4 Colistimethate sodium (Colistin, Colomycin Injection, Promixin, Coly-Mycin M) 132
  • 6.5 Cystic Fibrosis - Promising Drugs Under Clinical Development 133
    • 6.5.1 Denufosol Tetrasodium Inhalation Solution (INS37217) 133
    • 6.5.2 VX-770 134
    • 6.5.3 Bronchitol 134
    • 6.5.4 Ataluren (PTC-124) 135
  • 6.6 Phase III - Clinical Trial Analysis 136
    • 6.6.1 Completed Trial Analysis 136
    • 6.6.2 Active Trial Analysis 138
    • 6.6.3 Terminated Trial Analysis 141
  • 6.7 Phase II - Clinical Trial Analysis 143
    • 6.7.1 Completed Trial Analysis 143
    • 6.7.2 Active Trial Analysis 146
    • 6.7.3 Terminated Trial Analysis 149

7 Endpoints - Clinical Trials in Pulmonary Arterial Hypertension - Marketed and Pipeline Products Assessment 156

  • 7.1 Introduction 156
    • 7.1.1 Classification of Pulmonary Hypertension 156
  • 7.2 Primary Endpoints Used in Pulmonary Hypertension Trials 161
    • 7.2.1 Cardiopulmonary Hemodynamic Test 161
    • 7.2.2 Six Minutes Walking Distance 161
    • 7.2.3 Biomarkers 161
  • 7.3 Secondary Endpoints Used in Pulmonary Hypertension Trials 161
    • 7.3.1 Time to Clinical Worsening 161
    • 7.3.2 SF-36 Health Survey 161
  • 7.4 Pulmonary Arterial Hypertension - Major Marketed Drugs 161
    • 7.4.1 Tracleer 161
    • 7.4.2 Remodulin 162
    • 7.4.3 Revatio 163
    • 7.4.4 Ventavis 164
    • 7.4.5 Letairis 165
    • 7.4.6 Adcirca 166
  • 7.5 Pulmonary Arterial Hypertension - Promising Drugs under Clinical Development 167
    • 7.5.1 ACT-064992 167
    • 7.5.2 Oral Treprostinil 168
    • 7.5.3 ACT-293987 168
    • 7.5.4 Riociguat (BAY63-2521) 169
  • 7.6 Phase III Clinical Trial Analysis 170
    • 7.6.1 Completed Trial Analysis 170
    • 7.6.2 Active Trial Analysis 172
    • 7.6.3 Terminated Trial Analysis 175
  • 7.7 Phase II Clinical Trial Analysis 177
    • 7.7.1 Completed Trial Analysis 177
    • 7.7.2 Active Trial Analysis 180
    • 7.7.3 Terminated Trial Analysis 183

8 Endpoints - Clinical Trials in Respiratory Diseases - Company Profiling 187

  • 8.1 GlaxoSmithKline Plc 187
    • 8.1.1 Overview 187
    • 8.1.2 Respiratory Disease Portfolio 187
  • 8.2 AstraZeneca 188
    • 8.2.1 Overview 188
    • 8.2.2 Respiratory Disease Portfolio 188
  • 8.3 F.Hoffmann La Roche 188
    • 8.3.1 Overview 188
    • 8.3.2 Respiratory Disease Portfolio 188
  • 8.4 Merck & Co Inc 189
    • 8.4.1 Overview 189
    • 8.4.2 Respiratory Disease Portfolio 189
  • 8.5 Novartis AG 189
    • 8.5.1 Overview 189
    • 8.5.2 Respiratory Disease Portfolio 190
  • 8.6 Boehringer Ingelheim GmbH 190
    • 8.6.1 Overview 190
    • 8.6.2 Respiratory Disease Portfolio 190

9 Clinical Trials Endpoints in Respiratory Therapeutics - Appendix 191

  • 9.1 Market Definitions 191
  • 9.2 Abbreviations 191
  • 9.3 Sources 192
  • 9.4 Research Methodology 192
    • 9.4.1 Clinical Trial Design Overview 192
    • 9.4.2 Top Four Indications in Respiratory Therapy Area and their Product Profiling 193
    • 9.4.3 Marketed and Pipeline Products Assessment 193
    • 9.4.4 Company Profiling 193
    • 9.4.5 Expert Panel Validation 194
  • 9.5 Contact Us 194
  • 9.6 Disclaimer 194

List of Tables

1.1 List of Tables

  • Table 1: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Distribution of Clinical Trials, By Company, 2000-2010 19
  • Table 2: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Completed Phase III Clinical Trials, 2000-2010 32
  • Table 3: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Completed Phase III Clinical Trials, 2000-2010 34
  • Table 4: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Active Phase III Clinical Trials, 2000-2010 36
  • Table 5: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Active Phase III Clinical Trials, 2000-2010 38
  • Table 6: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Terminated Phase III Clinical Trials, 2000-2010 39
  • Table 7: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Terminated Phase III Clinical Trials, 2000-2010 40
  • Table 8: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Completed Phase II Clinical Trials, 2000-2010 42
  • Table 9: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Completed Phase II Clinical Trials, 2000-2010 44
  • Table 10: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Active Phase II Clinical Trials, 2000-2010 46
  • Table 11: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Active Phase II Clinical Trials, 2000-2010 48
  • Table 12: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Terminated Phase II Clinical Trials, 2000-2010 49
  • Table 13: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Terminated Phase II Clinical Trials, 2000-2010 51
  • Table 14: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Phase III Clinical Trials, 2000-2010 52
  • Table 15: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Phase II Clinical Trials, 2000-2010 64
  • Table 16: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Distribution of Clinical Trials, By Company, 2000-2010 79
  • Table 17: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Completed Phase III Clinical Trials, 2000-2010 91
  • Table 18: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Completed Phase III Clinical Trials, 2000-2010 93
  • Table 19: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Active Phase III Clinical Trials, 2000-2010 95
  • Table 20: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Active Phase III Clinical Trials, 2000-2010 97
  • Table 21: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Terminated Phase III Clinical Trials, 2000-2010 98
  • Table 22: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Terminated Phase III Clinical Trials, 2000-2010 99
  • Table 23: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Completed Phase II Clinical Trials, 2000-2010 101
  • Table 24: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Completed Phase II Clinical Trials, 2000-2010 103
  • Table 25: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Active Phase II Clinical Trials, 2000-2010 104
  • Table 26: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Active Phase II Clinical Trials, 2000-2010 106
  • Table 27: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Terminated Phase II Clinical Trials, 2000-2010 107
  • Table 28: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Terminated Phase II Clinical Trials, 2000-2010 108
  • Table 29: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Phase III Clinical Trials, 2000-2010 109
  • Table 30: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Phase II Clinical Trials, 2000-2010 117
  • Table 31: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Distribution of Clinical Trials, By Company, 2000-2010 128
  • Table 32: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Completed Phase III Clinical Trials, 2000-2010 136
  • Table 33: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Completed Phase III Clinical Trials, 2000-2010 137
  • Table 34: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Active Phase III Clinical Trials, 2000-2010 139
  • Table 35: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Active Phase III Clinical Trials, 2000-2010 140
  • Table 36: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Terminated Phase III Clinical Trials, 2000-2010 141
  • Table 37: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Terminated Phase III Clinical Trials, 2000-2010 142
  • Table 38: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Completed Phase II Clinical Trials, 2000-2010 144
  • Table 39: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Completed Phase II Clinical Trials, 2000-2010 145
  • Table 40: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Active Phase II Clinical Trials, 2000-2010 147
  • Table 41: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Active Phase II Clinical Trials, 2000-2010 148
  • Table 42: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Terminated Phase II Clinical Trials, 2000-2010 149
  • Table 43: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Terminated Phase II Clinical Trials, 2000-2010 150
  • Table 44: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Phase III Clinical Trials, 2000-2010 151
  • Table 45: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Phase II Clinical Trials, 2000-2010 153
  • Table 46: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Distribution of Clinical Trials, By Company, 2002-2010 160
  • Table 47: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Primary Endpoint Analysis of Completed Phase III Clinical Trials, 2002-2010 170
  • Table 48: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Completed Phase III Clinical Trials, 2002-2010 171
  • Table 49: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Primary Endpoint Analysis of Active Phase III Clinical Trials, 2002-2010 172
  • Table 50: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Active Phase III Clinical Trials, 2002-2010 174
  • Table 51: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Primary Endpoint Analysis of Terminated Phase III Clinical Trials, 2002-2010 175
  • Table 52: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Terminated Phase III Clinical Trials, 2002-2010 176
  • Table 53: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Primary Endpoint Analysis of Completed Phase II Clinical Trials, 2002-2010 177
  • Table 54: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Completed Phase II Clinical Trials, 2002-2010 179
  • Table 55: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Primary Endpoint Analysis of Active Phase II Clinical Trials, 2002-2010 180
  • Table 56: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Active Phase II Clinical Trials, 2002-2010 182
  • Table 57: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Primary Endpoint Analysis of Terminated Phase II Clinical Trials, 2002-2010 183
  • Table 58: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Terminated Phase II Clinical Trials, 2002-2010 184
  • Table 59: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Phase III Clinical Trials, 2002-2010 185
  • Table 60: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Phase II Clinical Trials, 2002-2010 186
  • Table 61: GlaxoSmithKline Plc, Marketed Respiratory Drugs Portfolio, 2010 187
  • Table 62: AstraZeneca, Marketed Respiratory Drugs Portfolio, 2010 188
  • Table 63: F.Hoffmann La Roche, Marketed Respiratory Drugs Portfolio, 2010 188
  • Table 64: Merck & Co, Marketed Respiratory Drugs Portfolio, 2010 189
  • Table 65: Novartis AG, Marketed Respiratory Drugs Portfolio, 2010 190
  • Table 66: Boehringer Ingelheim, Marketed Respiratory Drugs Portfolio, 2010 190

List of Figures

1.2 List of Figures

  • Figure 1: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Total Number Of Clinical Trials, 2000-2010 16
  • Figure 2: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Phase of Clinical Trials, 2000-2010 17
  • Figure 3: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Status of Clinical Trials, 2000-2010 18
  • Figure 4: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Distribution of Clinical Trials, By Company (%), 2000-2010 19
  • Figure 5: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Completed Phase III Clinical Trials, (%), 2000-2010 31
  • Figure 6: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Completed Phase III Clinical Trials, (%), 2000-2010 33
  • Figure 7: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Active Phase III Clinical Trials, (%), 2000-2010 35
  • Figure 8: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Active Phase III Clinical Trials, (%), 2000-2010 37
  • Figure 9: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Terminated Phase III Clinical Trials, (%), 2000-2010 39
  • Figure 10: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Terminated Phase III Clinical Trials, (%), 2000-2010 40
  • Figure 11: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Completed Phase II Clinical Trials, (%), 2000-2010 41
  • Figure 12: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Completed Phase II Clinical Trials, (%), 2000-2010 43
  • Figure 13: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Active Phase II Clinical Trials, (%), 2000-2010 45
  • Figure 14: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Active Phase II Clinical Trials, (%), 2000-2010 47
  • Figure 15: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Terminated Phase II Clinical Trials, (%), 2000-2010 49
  • Figure 16: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Terminated Phase II Clinical Trials, (%), 2000-2010 50
  • Figure 17: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Total Number of Clinical Trials, 2000-2010 76
  • Figure 18: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Phase of Clinical Trials, 2000-2010 77
  • Figure 19: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Status of Clinical Trials, 2000-2010 78
  • Figure 20: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Distribution of Clinical Trials, By Company (%), 2000-2010 79
  • Figure 21: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Completed Phase III Clinical Trials, (%), 2000-2010 90
  • Figure 22: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Completed Phase III Clinical Trials, (%), 2000-2010 92
  • Figure 23: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Active Phase III Clinical Trials, (%), 2000-2010 94
  • Figure 24: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Active Phase III Clinical Trials, (%), 2000-2010 96
  • Figure 25: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Terminated Phase III Clinical Trials, (%), 2000-2010 98
  • Figure 26: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Terminated Phase III Clinical Trials, (%), 2000-2010 99
  • Figure 27: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Completed Phase II Clinical Trials, (%), 2000-2010 100
  • Figure 28: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Completed Phase II Clinical Trials, (%), 2000-2010 102
  • Figure 29: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Active Phase II Clinical Trials, (%), 2000-2010 104
  • Figure 30: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Active Phase II Clinical Trials, (%), 2000-2010 105
  • Figure 31: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Terminated Phase II Clinical Trials, (%), 2000-2010 107
  • Figure 32: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Terminated Phase II Clinical Trials, (%), 2000-2010 108
  • Figure 33: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Total Number of Clinical Trials, 2000-2010 125
  • Figure 34: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Phase of Clinical Trials, 2000-2010 126
  • Figure 35: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Status of Clinical Trials, 2000-2010 127
  • Figure 36: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Distribution of Clinical Trials, By Company (%), 2000-2010 128
  • Figure 37: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Completed Phase III Clinical Trials, (%), 2000-2010 136
  • Figure 38: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Completed Phase III Clinical Trials, (%), 2000-2010 137
  • Figure 39: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Active Phase III Clinical Trials, (%), 2000-2010 138
  • Figure 40: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Active Phase III Clinical Trials, (%), 2000-2010 139
  • Figure 41: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Terminated Phase III Clinical Trials, (%), 2000-2010 141
  • Figure 42: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Terminated Phase III Clinical Trials, (%), 2000-2010 142
  • Figure 43: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Completed Phase II Clinical Trials, (%), 2000-2010 143
  • Figure 44: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Completed Phase II Clinical Trials, (%), 2000-2010 145
  • Figure 45: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Active Phase II Clinical Trials, (%), 2000-2010 146
  • Figure 46: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Active Phase II Clinical Trials, (%), 2000-2010 148
  • Figure 47: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Terminated Phase II Clinical Trials, (%), 2000-2010 149
  • Figure 48: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Terminated Phase II Clinical Trials, (%), 2000-2010 150
  • Figure 49: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Total Number of Clinical Trials, 2002-2010 157
  • Figure 50: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Phase of Clinical Trials, 2002-2010 158
  • Figure 51: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Status of Clinical Trials, 2002-2010 159
  • Figure 52: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Distribution of Clinical Trials, By Company (%),2002-2010 160
  • Figure 53: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Primary Endpoint Analysis of Completed Phase III Clinical Trials, (%), 2002-2010 170
  • Figure 54: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Completed Phase III Clinical Trials, (%), 2002-2010 171
  • Figure 55: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Primary Endpoint Analysis of Active Phase III Clinical Trials, (%), 2002-2010 172
  • Figure 56: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Active Phase III Clinical Trials, (%), 2002-2010 173
  • Figure 57: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Primary Endpoint Analysis of Terminated Phase III Clinical Trials, (%), 2002-2010 175
  • Figure 58: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Terminated Phase III Clinical Trials, (%),2002-2010 176
  • Figure 59: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Primary Endpoint Analysis of Completed Phase II Clinical Trials, (%), 2002-2010 177
  • Figure 60: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Completed Phase II Clinical Trials, (%), 2002-2010 178
  • Figure 61: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension Global, Primary Endpoint Analysis of Active Phase II Clinical Trials, (%), 2002-2010 180
  • Figure 62: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Active Phase II Clinical Trials, (%), 2002-2010 181
  • Figure 63: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Primary Endpoint Analysis of Terminated Phase II Clinical Trials, (%), 2002-2010 183
  • Figure 64: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Terminated Phase II Clinical Trials, (%), 2002-2010 184
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