NCT00322686

Brief Summary

The purpose of this study is to determine whether oglemilast is safe and effective in the treatment of allergen-induced asthma.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_2 asthma

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

7 months

First QC Date

May 4, 2006

Last Update Submit

March 16, 2012

Conditions

Asthma

Keywords

oglemilastasthmaallergenpreventionprophylaxisAllergen-Induced Asthma

Outcome Measures

Primary Outcomes (1)

  • To determine the effect of oglemilast in the prevention of bronchoconstriction after the administration of allergen, in comparison with placebo in patients with mild asthma

    From Baseline to Day 7

Secondary Outcomes (1)

  • To evaluate the safety of oglemilast over 2 weeks as determined by adverse events,physical examinations, vital signs, electrocardiograms, and laboratory examinations

    From Baseline to Day 14

Study Arms (2)

Oglemilast followed by placebo

EXPERIMENTAL
Drug: Oglemilast

Placebo followed by Oglemilast

EXPERIMENTAL
Drug: Placebo then Oglemilast

Interventions

OglemilastDRUG

Oglemilast, 15mg oral administration, once per day and then dose-matched placebo

Oglemilast followed by placebo
Placebo then OglemilastDRUG

Dose-matched placebo and then Oglemilast, 15mg, oral administration, once per day.

Placebo followed by Oglemilast

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mild atopic asthma
  • Hyperreactivity to methacholine
  • Exhibit positive response to standard allergen skin prick test

You may not qualify if:

  • Pulmonary disease other than asthma
  • Asthma exacerbation within 4 weeks
  • History of substance abuse
  • Active cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forest Investigative Site

Los Angeles, California, 90025, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

oglemilast

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2006

First Posted

May 8, 2006

Study Start

May 1, 2006

Primary Completion

December 1, 2006

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

US(1)