Study of Oglemilast for the Treatment of Asthma

NCT ID: NCT00322686

Last Updated: 2012-03-20

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Brief Summary

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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oglemilast followed by placebo

Group Type EXPERIMENTAL

Oglemilast

Intervention Type DRUG

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

Placebo followed by Oglemilast

Group Type EXPERIMENTAL

Placebo then Oglemilast

Intervention Type DRUG

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

Interventions

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Oglemilast

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

Intervention Type DRUG

Placebo then Oglemilast

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pulmonary disease other than asthma
* Asthma exacerbation within 4 weeks
* History of substance abuse
* Active cardiac disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Forest Investigative Site

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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GRC-MD-03

Identifier Type: -

Identifier Source: org_study_id

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