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

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ClinicalTrials.gov Identifier: NCT01006161
Recruitment Status : Withdrawn
First Posted : November 2, 2009
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: SCH 527123 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Proof-of-Concept and Dose Range-Finding Study of SCH 527123 in Subjects With Severe Asthma
Study Start Date : January 2010
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Low dose SCH 527123 Drug: SCH 527123
Low dose
Experimental: Medium dose SCH 527123 Drug: SCH 527123
Medium dose
Experimental: High dose SCH 527123 Drug: SCH 527123
High dose
Placebo Comparator: Placebo Drug: SCH 527123
Placebo to match SCH 527123



Primary Outcome Measures :
  1. Severe asthma exacerbations, pulmonary function test data, and a change in symptoms [ Time Frame: Measured over the duration of the trial. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01006161     History of Changes
Other Study ID Numbers: P05109
EUDRACT No.: 2008-004119-36
First Posted: November 2, 2009    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases