ClinicalTrials.gg
CompletedNCT00322283Updated Apr 10, 2012

Study of Oglemilast for the Prevention of Asthma.

A Phase 2 interventional study of Oglemilast and Placebo in Exercise-Induced Asthma, sponsored by Forest Laboratories. Completed at 2 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-04-10.

Sponsored by Forest Laboratories (part of AbbVie) · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether it is effective in the treatment of exercise-induced asthma and investigate the safety of oglemilast.

02

Conditions studied

  • Exercise-Induced Asthma

Keywords

  • oglemilast
  • asthma
  • exercise
  • prevention
  • prophylaxis
03

In context

Asthma, Exercise-Induced

52 studies on the registry are indexed under Asthma, Exercise-Induced; 3 are open to participants now.

This study's enrollment of 24 is below the median of 47 across 40 interventional studies indexed under Asthma, Exercise-Induced.

Browse Asthma, Exercise-Induced studies →

Lead sponsor

Forest Laboratories is the lead sponsor of 168 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.

First submitted before Forest Laboratories became part of AbbVie.

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • stable mild asthma patients who exhibit at least a 20% decrease in following exercise.

Exclusion criteria

Exclusion Criteria:

  • pulmonary disease other than asthma, psychiatric illness, active cardiac disease, high blood pressure, history of substance abuse, current smokers.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Oglemilast

    Drug: Oglemilast

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • Oglemilast, 15mg once per day, oral administration

  • DrugPlacebo

    Dose-marched placebo, once per day, oral administration

06

What researchers measure

Primary outcomes

  1. To determine the efficacy of oglemilast as compared to placebo in preventing exercise-induced asthma following 15 days of treatment.

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.

07

Study locations

2 sites
  • Forest Investigative Site
    Los Angeles, California 90025, United States
  • Forest Investigative Site
    N. Dartmouth, Massachusetts 02747, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2006, a primary completion of Oct 2006 and a completion of Oct 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 4, 2006
First posted
May 5, 2006
Start
May 2006
Primary completionActual
Oct 2006
CompletionActual
Oct 2006
Last update
Apr 10, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00322283
First posted
May 5, 2006
Start date
May 2006
Primary completion
Oct 2006
Completion
Oct 2006
Last update
Apr 10, 2012
View the source record on ClinicalTrials.gov ↗

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

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Discussion

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Studies of the drug tested here: Oglemilast

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