Neutrophilic Asthma Study With SCH 527123 (Study P05365AM2)(COMPLETED)
This study has been completed.
Information provided by:
First received: February 29, 2008
Last updated: March 14, 2013
Last verified: March 2013
4-Week Safety Study in Subjects with Neutrophilic Asthma
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Safety of SCH 527123 in Subjects With Neutrophilic Asthma|
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- The primary endpoint is safety. [ Time Frame: Throughout the 4 weeks (Week 5 is a safety follow-up visit) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Effects of Treatment with SCH 527123: Reducing levels of sputum neutrophils. PK parameters. Asthma symptoms, PFTs, QOL, ECGs, lab assessments, & AEs. [ Time Frame: Data: to be summarized and analyzed at 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2008|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Experimental: SCH 527123
30 mg capsule, to be taken once daily in the morning
Drug: SCH 527123
30 mg capsule to be taken once daily in the morning for 4 weeks.
Placebo Comparator: Placebo
Placebo capsule to match SCH 527123, to be taken once daily in the morning
Placebo capsule to match SCH 527123 to be taken once daily in the morning for 4 weeks.
Effect of treatment with SCH 527123 on sputum neutrophils and asthma symptoms. Pharmacokinetics of SCH 527123.
Contacts and Locations
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