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

Merck Sharp & Dohme LLC

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Asthma

Interventions

SCH 527123DRUG

Low dose

SCH 527123DRUG

Medium dose

SCH 527123DRUG

High dose

SCH 527123DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Severe asthma exacerbations, pulmonary function test data, and a change in symptoms

Time frame: Measured over the duration of the trial.

Data from ClinicalTrials.gov

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