Study of SCH 527123 in Subjects With Severe Asthma (Study P05109AM1)

Phase 2

Withdrawn

• Conditions: Asthma
• Interventions: Drug: SCH 527123

• Registration Number: NCT01006161
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Given the strong inhibition of SCH 527123 on neutrophil migration to sites of inflammation, there is a theoretical reason for its use in patients with severe asthma where neutrophils are thought to play a significant role in the pathophysiology of the disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-30
• Study First Submitted QC: 2009-10-30
• Study First Posted: 2009-11-01
• Study Start: 2010-01
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-12
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Subject must have severe asthma, be at least 18 to less than or equal to 70 years of age, of either sex, and any race.

Exclusion Criteria

• Subject who has been diagnosed with COPD or any other clinically relevant lung disease, other than asthma (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose SCH 527123	SCH 527123	-
Medium dose SCH 527123	SCH 527123	-
High dose SCH 527123	SCH 527123	-
Placebo	SCH 527123	-

Primary Outcome Measures

Name	Time	Method
Severe asthma exacerbations, pulmonary function test data, and a change in symptoms	Measured over the duration of the trial.