The Tolerability and Effects of AZD8848 in Allergic Asthma Subjects Challenged With Inhaled Allergen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00999466
First received: October 20, 2009
Last updated: December 17, 2015
Last verified: December 2015
  Purpose
AZD8848 is a new drug that is being tested for the treatment of asthma and allergic rhinitis (hayfever). This study will be in two parts and will include 59 asthmatic patients in total. The first part will investigate the tolerability and safety of AZD8848 while the second part will investigate both the therapeutic effect of AZD8848 and how well patients tolerate the drug.

Condition Intervention Phase
Allergic Asthma
Drug: AZD8848
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomised, Parallel Group, Phase IIa Study to Investigate the Efficacy, Tolerability and Safety of 8 Doses of AZD8848 Administered Intranasally Once Weekly in Mild to Moderate Allergic Asthma Subjects Challenged With an Inhaled Allergen.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • FEV1, Late Asthmatic Response (LAR) - Pre-treatment [ Time Frame: Pre-treatment (Baseline measurement) ] [ Designated as safety issue: No ]
    Forced Expiratory Volume in 1 second (FEV1), Late Asthmatic Response (LAR), is derived as the ratio of FEV1 Area Under Curve 4-10 hour post allergen challenge (AUC 4-10h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

  • FEV1, Late Asthmatic Response (LAR) - 1 Week After Last Dose [ Time Frame: 1 week after last dose ] [ Designated as safety issue: No ]
    FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

  • FEV1, Late Asthmatic Response (LAR) - 4 Weeks After Last Dose [ Time Frame: 4 weeks after last dose ] [ Designated as safety issue: No ]
    FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.


Secondary Outcome Measures:
  • FEV1, Early Asthmatic Response (EAR) - Pre-treatment [ Time Frame: Pre-treatment (Baseline measurement) ] [ Designated as safety issue: No ]
    FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 Area Under Curve 0-2 hour post allergen challenge (AUC 0-2h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

  • FEV1, Early Asthmatic Response (EAR) - 1 Week After Last Dose [ Time Frame: 1 week after last dose ] [ Designated as safety issue: No ]
    FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

  • FEV1, Early Asthmatic Response (EAR) - 4 Weeks After Last Dose [ Time Frame: 4 weeks after last dose ] [ Designated as safety issue: No ]
    FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

  • PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
    PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

  • PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
    PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

  • PC20 Methacholine Challenge - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
    PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

  • PC20 Methacholine Challenge - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
    PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

  • PC20 Methacholine Challenge - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
    PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

  • PC20 Methacholine Challenge - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
    PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

  • Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, TNFα - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-1β - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-5 - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-6 - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-8 - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-10 - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-13 - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: October 2009
Study Completion Date: December 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD8848 (30 μg PILOT part and 60 μg MAIN part)
Drug: AZD8848
Nasal spray, solution 0.6mg/ mL. Once weekly for 7 weeks, 8 doses in total.
Placebo Comparator: 2
Placebo
Drug: Placebo
Nasal spray, solution. Once weekly for 7 weeks, 8 doses in total.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • FEV1 > 70 % of predicted normal pre-bronchodilator
  • Documented history of asthma
  • Presence of allergic sensitivity

Exclusion Criteria:

  • Clinically relevant disease and/or abnormality (past or present), which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study.
  • Symptomatic allergic rhinitis
  • Any clinical relevant abnormal findings in physical examination or assessment which may put the patient at risk because of participation in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999466

Locations
United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Leif Eriksson, MD AstraZeneca R&D Lund
Principal Investigator: Brian Leaker, MD Respiratory Clinical Trials
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00999466     History of Changes
Other Study ID Numbers: D0540C00004 
Study First Received: October 20, 2009
Results First Received: August 31, 2015
Last Updated: December 17, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 08, 2016