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

Asthma Clinical Trial

Official title:

Proof-of-Concept and Dose Range-Finding Study of SCH 527123 in Subjects With Severe Asthma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01006161
• Other study ID #: P05109
• Secondary ID: EUDRACT No.: 200
• Status: Withdrawn
• Phase: Phase 2
• First received: October 30, 2009
• Last updated: October 12, 2015
• Start date: January 2010
• Est. completion date: August 2012

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada, Therapeutic Products Directorate
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• SCH 527123
Low dose
• SCH 527123
Medium dose
• SCH 527123
High dose
• SCH 527123
Placebo to match SCH 527123

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe asthma exacerbations, pulmonary function test data, and a change in symptoms		Measured over the duration of the trial.	No