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CompletedNCT00322686Updated Mar 20, 2012

Study of Oglemilast for the Treatment of Asthma

A Phase 2 interventional study of Oglemilast and Placebo then Oglemilast in Asthma, sponsored by Forest Laboratories. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-03-20.

Sponsored by Forest Laboratories · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Asthma

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Keywords

  • oglemilast
  • asthma
  • allergen
  • prevention
  • prophylaxis
  • Allergen-Induced Asthma
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 6 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pulmonary disease other than asthma
  • Asthma exacerbation within 4 weeks
  • History of substance abuse
  • Active cardiac disease
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Oglemilast followed by placebo

    Drug: Oglemilast

  • Experimental
    Placebo followed by Oglemilast

    Drug: Placebo then Oglemilast

Interventions

  • DrugOglemilast

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

  • DrugPlacebo then Oglemilast

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

06

What researchers measure

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

    Time frame: 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

    Time frame: From Baseline to Day 14

07

Study locations

1 site
  • Forest Investigative Site
    Los Angeles, California 90025, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00322686
Lead sponsor
Forest Laboratories
Responsible party
Sponsor
First posted
May 8, 2006
Start date
May 2006
Primary completion
Dec 2006
Last update
Mar 20, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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