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

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

Endpoints - Clinical Trials in Respiratory Diseases - Pulmonary Function Tests, Biomarkers and Quality of Life Questionnaires All Play Prominent Roles - GBI Research Reports
Endpoints - Clinical Trials in Respiratory Diseases - Pulmonary Function Tests, Biomarkers and Quality of Life Questionnaires All Play Prominent Roles
Published Jun 25, 2012
194 pages — Published Jun 25, 2012
Price US$ 3,500.00  |  Buy this Report Now

About This Report

  
Abstract:

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 diseases 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 indications and clinical Phase of trial. This will help in designing clinical trials so as to and protect ones 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 drugs time to market.
- Exploit strategies for designing of clinical trials by identifying the advantages and disadvantages involved with the use of specific endpoints.

  
Source:
Document ID
GBIHC153MR
Industry
Format:
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Sections

TitleStarting PageNumber of Pages
Table of Contents58
  List of Tables82
  List of Figures103
Introduction131
Clinical Trials Endpoints in Respiratory Diseases - An Overview142
  Introduction141
  Types of Endpoints141
    Primary Endpoints141
    Secondary Endpoints141
    Surrogate Endpoints151
Endpoints - Clinical Trials in Asthma - Marketed and Pipeline Products Assessment1660
  Introduction164
  Primary Endpoints Used in Asthma Clinical Trials201
    Pulmonary Function Tests:201
    Vital Signs and Physical Activity201
    Biomarkers201
    Serious Adverse Events201
  Secondary Endpoints Used in Asthma Clinical Trials211
    Pharmacokinetics and Pharmacodynamics211
    Quality of Life Scores211
    Clinical Laboratory Tests Biochemistry and Serum Hematology211
    Use of Rescue Medication211
  Asthma Therapeutics Major Marketed Drugs211
    Singulair (Montekeulast Sodium)211
      Overview211
      Efficacy211
      Safety211
      Clinical Study Details221
    Accolate Accoleit, Vanticon (Zafirlukast)221
      Overview221
      Efficacy221
      Safety231
      Clinical Study Details231
    Zyflo (Zileuton)231
      Overview231
      Efficacy231
      Safety231
      Clinical Study Details241
    Foradil (Formoterol Fumarate Inhalation Powder)241
      Overview241
      Efficacy241
      Safety241
      Clinical Study Details251
    Symbicort (budesonide/formoterol fumarate dihydrate inhalation aerosol)251
      Overview251
      Efficacy261
      Safety261
      Clinical Study Details261
    Xolair (Omalizumab)271
      Overview271
      Efficacy271
      Safety271
      Clinical Study Details271
    Serevent Diskus (Salmaterol Xinafoate Inhalation Powder)281
      Overview281
      Efficacy281
      Safety291
      Clinical Study Details291
    Advair Diskus (Fluticasone Propionate and Salmeterol Inhalation Powder)291
      Overview291
      Efficacy291
      Safety291
      Clinical Study Details301
  Asthma Therapeutics Promising Drugs under Clinical Development301
    Daxas (Roflumilast) (Daxas, APTA 2217, B9302-107, BY 217, BYK 20869)301
      Overview301
      Efficacy301
      Safety301
      Clinical Study Details311
  Phase III Clinical Trial Analysis311
    Completed Trial Analysis314
    Active Trial Analysis354
    Terminated Trial Analysis392
  Phase II Clinical Trial Analysis411
    Completed Trial Analysis414
    Active Trial Analysis454
    Terminated Trial Analysis4927
Endpoints - Clinical Trials in Chronic Obstructive Pulmonary Disorder - Marketed and Pipeline Products Assessment7649
  Introduction764
  Primary Endpoints Used in COPD Clinical Trials801
    Pulmonary Function Tests801
    Baseline Dyspnea Index and Borg-Dyspnea Score801
    Rate of Exacerbations801
    Induced Sputum Analysis801
    Biomarkers of COPD801
  Secondary Endpoints Used in COPD Clinical Trials801
    Exercise Endurance Time801
    Serum Hematology801
    Six Minute Walk Distance801
    Time to First Exacerbation811
  COPD Therapeutics Major Marketed Drugs811
    Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder)811
      Overview811
      Efficacy811
      Safety811
      Clinical Study Details811
    Brovana (Arformoterol)821
      Overview821
      Efficacy821
      Safety821
      Clinical Study Details821
    Foradil Aerolizer (Formoterol Fumarate Inhalation Powder)831
      Overview831
      Efficacy831
      Safety831
      Clinical Study Details831
    Symbicort (Budesonide/Formoterol Fumarate Dihydrate)841
      Overview841
      Efficacy841
      Safety841
      Clinical Study Details841
    Advair Diskus (Fluticasone Propionate and Salmeterol Inhalation Powder)851
      Overview851
      Efficacy851
      Safety851
      Clinical Study Details852
    Daxas (roflumilast)871
      Overview871
      Efficacy871
      Safety871
      Clinical Study Details871
  COPD Therapeutics Promising Drugs Under Clinical Development881
    Aclidinium Bromide881
      Overview881
      Efficacy881
      Safety881
      Clinical Study Details881
    NVA237 (Glycopyrronium Bromide)891
      Overview891
      Efficacy891
      Safety891
      Clinical Study Details891
    Dulera891
      Overview891
      Clinical Study Details901
  Phase III Clinical Trial Analysis901
    Completed Trial Analysis904
    Active Trials Analysis944
    Terminated Trial Analysis982
  Phase II Clinical Trial Analysis1001
    Completed Trial Analysis1004
    Active Trial Analysis1043
    Terminated Trial Analysis10718
Endpoints - Clinical Trials in Cystic Fibrosis - Marketed and Pipeline Products Assessment12531
  Introduction1254
  Primary Endpoints Used in Cystic Fibrosis Clinical Trials1291
    Coefficient of Fat Absorption1291
    Lung Microbiology1291
    Biomarkers1291
  Secondary Endpoints Used in Cystic Fibrosis Clinical Trials1291
    Nasal Potential Difference1291
    Sweat Chloride Concentration1291
  Cystic Fibrosis Therapeutics Major Marketed Drugs1291
    Tobi (Tobramycin Inhalation Solution)1291
      Overview1291
      Efficacy1301
      Safety1301
      Clinical Study Details1301
    Pulmozyme (Dornase Alfa)1301
      Overview1301
      Efficacy1311
      Safety1311
      Clinical Study Details1311
    Cayston (aztreonam for Inhalation Solution)1311
      Overview1311
      Efficacy1311
      Safety1321
      Clinical Study Details1321
    Colistimethate sodium (Colistin, Colomycin Injection, Promixin, Coly-Mycin M)1321
      Overview1321
      Efficacy1321
      Safety1331
  Cystic Fibrosis Promising Drugs Under Clinical Development1331
    Denufosol Tetrasodium Inhalation Solution (INS37217)1331
      Overview1331
      Efficacy1331
      Safety1331
      Clinical Study Details1331
    VX-7701341
      Overview1341
      Efficacy1341
      Safety1341
      Clinical Study Details1341
    Bronchitol1341
      Overview1341
      Efficacy1341
      Safety1351
      Clinical Study Details1351
    Ataluren (PTC-124)1351
      Overview1351
      Efficacy1351
      Safety1351
      Clinical Study Details1351
  Phase III Clinical Trial Analysis1361
    Completed Trial Analysis1362
    Active Trial Analysis1383
    Terminated Trial Analysis1412
  Phase II Clinical Trial Analysis1431
    Completed Trial Analysis1433
    Active Trial Analysis1463
    Terminated Trial Analysis1497
Endpoints - Clinical Trials in Pulmonary Arterial Hypertension - Marketed and Pipeline Products Assessment15631
  Introduction1561
    Classification of Pulmonary Hypertension1565
  Primary Endpoints Used in Pulmonary Hypertension Trials1611
    Cardiopulmonary Hemodynamic Test1611
    Six Minutes Walking Distance1611
    Biomarkers1611
  Secondary Endpoints Used in Pulmonary Hypertension Trials1611
    Time to Clinical Worsening1611
    SF-36 Health Survey1611
  Pulmonary Arterial Hypertension Major Marketed Drugs1611
    Tracleer1611
      Overview1611
      Efficacy1611
      Safety Profile1621
      Clinical Study Details1621
    Remodulin1621
      Overview1621
      Efficacy1621
      Safety1621
      Clinical Study Details1631
    Revatio1631
      Overview1631
      Efficacy1631
      Safety1631
      Clinical Study Details1631
    Ventavis1641
      Overview1641
      Safety1641
      Clinical Study Details1641
    Letairis1651
      Overview1651
      Efficacy1651
      Safety1651
      Clinical Study Details1651
    Adcirca1661
      Overview1661
      Efficacy1661
      Safety1661
      Clinical Study Details1661
  Pulmonary Arterial Hypertension Promising Drugs under Clinical Development1671
    ACT-0649921671
      Overview1671
      Efficacy1671
      Safety1671
      Clinical Study Details1671
    Oral Treprostinil1681
      Overview1681
      Efficacy1681

Table Of Contents

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MLA:
GBI Research Reports. "Endpoints - Clinical Trials in Respiratory Diseases - Pulmonary Function Tests, Biomarkers and Quality of Life Questionnaires All Play Prominent Roles" Jun 25, 2012. Alacra Store. May 05, 2025. <http://www.alacrastore.com/storecontent/GBI-Research-Reports/Endpoints-Clinical-Trials-in-Respiratory-Diseases-Pulmonary-Function-Tests-Biomarkers-and-Quality-of-Life-Questionnaires-All-Play-Prominent-Roles-2115-442>
  
APA:
GBI Research Reports. (2012). Endpoints - Clinical Trials in Respiratory Diseases - Pulmonary Function Tests, Biomarkers and Quality of Life Questionnaires All Play Prominent Roles Jun 25, 2012. New York, NY: Alacra Store. Retrieved May 05, 2025 from <http://www.alacrastore.com/storecontent/GBI-Research-Reports/Endpoints-Clinical-Trials-in-Respiratory-Diseases-Pulmonary-Function-Tests-Biomarkers-and-Quality-of-Life-Questionnaires-All-Play-Prominent-Roles-2115-442>
  
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