Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
MedImmune LLC Cambridge Antibody Technology PRA International |
---|---|
Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00640016 |
To investigate the effects of CAT-354 on airway hyperresponsiveness (AHR) in uncontrolled asthma.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: CAT-354 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of CAT-354 |
Enrollment: | 14 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
CAT-354
|
Drug: CAT-354
1 mg/kg CAT-354 on Day 0, 28, and 56 5 mg/kg CAT-354 on Day 0, 28, and 56 10 mg/kg CAT-354 on Day 0, 28, and 56
|
2: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo to match all doses of CAT-354 on Day 0, 28, and 56.
|
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
fluticasone/salmeterol - Advair®/Seretide® or Symbicort (budesonide/formoterol) SMART®) they must receive the two components as two separate inhaler medications for the purpose of the trial. This will facilitate withholding the long-acting b-agonist component before lung function and challenge testing (see Section 9.5.7). The GINA 2006 [14] levels of asthma control and treatment are described in Appendix 3.
Exclusion Criteria:
Study Director: | Thomas Mayer, M.D. | PRA International |
Responsible Party: | PRA International ( Thomas Mayer, MD ) |
Study ID Numbers: | CAT-354-0603 |
Study First Received: | March 13, 2008 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00640016 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Australia: National Health and Medical Research Council; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Asthma |