NCT00322283

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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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
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

April 10, 2012

Status Verified

April 1, 2012

Enrollment Period

5 months

First QC Date

May 4, 2006

Last Update Submit

April 7, 2012

Conditions

Exercise-Induced Asthma

Keywords

oglemilastasthmaexercisepreventionprophylaxis

Outcome Measures

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.

Study Arms (2)

Oglemilast

EXPERIMENTAL
Drug: Oglemilast

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

OglemilastDRUG

Oglemilast, 15mg once per day, oral administration

Oglemilast
PlaceboDRUG

Dose-marched placebo, once per day, oral administration

Placebo

Eligibility Criteria

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

You may qualify if:

  • stable mild asthma patients who exhibit at least a 20% decrease in FEV1 following exercise.

You may not qualify if:

  • pulmonary disease other than asthma, psychiatric illness, active cardiac disease, high blood pressure, history of substance abuse, current smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Forest Investigative Site

Los Angeles, California, 90025, United States

Location

Forest Investigative Site

North Dartmouth, Massachusetts, 02747, United States

Location

MeSH Terms

Conditions

Asthma, Exercise-InducedAsthmaMotor Activity

Interventions

oglemilast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityExercise-Induced AllergiesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLung Diseases, ObstructiveLung DiseasesBehavior

Study Design

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

Study Record Dates

First Submitted

May 4, 2006

First Posted

May 5, 2006

Study Start

May 1, 2006

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

April 10, 2012

Record last verified: 2012-04

Locations

US(2)