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

Merck Sharp & Dohme (MSD)

Status and phase: Withdrawn; Phase 2

Conditions: Asthma

Treatments: Drug: SCH 527123

Study type: Interventional

Funder types: Industry

Identifiers

NCT01006161

P05109

EUDRACT No.: 2008-004119-36

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups, including a placebo group

Low dose SCH 527123

Experimental group

Treatment:

Drug: SCH 527123

Drug: SCH 527123

Drug: SCH 527123

Drug: SCH 527123

Medium dose SCH 527123

Experimental group

Treatment:

Drug: SCH 527123

Drug: SCH 527123

Drug: SCH 527123

Drug: SCH 527123

High dose SCH 527123

Experimental group

Treatment:

Drug: SCH 527123

Drug: SCH 527123

Drug: SCH 527123

Drug: SCH 527123

Placebo

Placebo Comparator group

Treatment:

Drug: SCH 527123

Drug: SCH 527123

Drug: SCH 527123

Drug: SCH 527123