NCT01006161

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2010

Typical duration for phase_2 asthma

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

2.6 years

First QC Date

October 30, 2009

Last Update Submit

October 12, 2015

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

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

    Measured over the duration of the trial.

Study Arms (4)

Low dose SCH 527123

EXPERIMENTAL
Drug: SCH 527123

Medium dose SCH 527123

EXPERIMENTAL
Drug: SCH 527123

High dose SCH 527123

EXPERIMENTAL
Drug: SCH 527123

Placebo

PLACEBO COMPARATOR
Drug: SCH 527123

Interventions

SCH 527123DRUG

Low dose

Low dose SCH 527123

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subject who has been diagnosed with COPD or any other clinically relevant lung disease, other than asthma (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

2-hydroxy-N,N-dimethyl-3-(2-((1-(5-methylfuran-2-yl)propyl)amino)-3,4-dioxocyclobut-1-enylamino)benzamide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2009

First Posted

November 2, 2009

Study Start

January 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 14, 2015

Record last verified: 2015-10