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

NCT ID: NCT01006161

Last Updated: 2015-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-08-31

Brief Summary

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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

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low dose SCH 527123

Group Type EXPERIMENTAL

SCH 527123

Intervention Type DRUG

Low dose

Medium dose SCH 527123

Group Type EXPERIMENTAL

SCH 527123

Intervention Type DRUG

Medium dose

High dose SCH 527123

Group Type EXPERIMENTAL

SCH 527123

Intervention Type DRUG

High dose

Placebo

Group Type PLACEBO_COMPARATOR

SCH 527123

Intervention Type DRUG

Placebo to match SCH 527123

Interventions

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SCH 527123

Low dose

Intervention Type DRUG

SCH 527123

Medium dose

Intervention Type DRUG

SCH 527123

High dose

Intervention Type DRUG

SCH 527123

Placebo to match SCH 527123

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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EUDRACT No.: 2008-004119-36

Identifier Type: -

Identifier Source: secondary_id

P05109

Identifier Type: -

Identifier Source: org_study_id

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