Study of Oglemilast for the Prevention of Asthma. | NCT00322283

Studies
Study of Oglemilast for the Prevention of Asthma.

NCT00322283

Sponsor

Forest Laboratories

Status

Completed

Last Update Posted

Apr 10, 2012Estimated

Enrollment

24Actual

Phase

Phase 2

Conditions

Exercise-Induced Asthma

Interventions

Oglemilast
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Oct 2006Actual

Completion Date

Oct 2006Actual

First Submitted Date

May 4, 2006

First Submission Date that Met QC Criteria

May 4, 2006

First Posted Date

May 5, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2012

Last Update Posted Date

Apr 10, 2012Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oglemilast	Experimental		Drug: Oglemilast
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oglemilast	Drug	Oglemilast, 15mg once per day, oral administration	Oglemilast

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the safety of oglemilast over 2 weeks as determined by adverse events, physical examinations, vital signs, electrocardiograms, and laboratory examinations.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Forest Investigative Site		Los Angeles	California	90025	United States
Forest Investigative Site

Condition Browse Module

MeSH Terms

ID	Term
D001250	Asthma, Exercise-Induced
D001249	Asthma
D009043	Motor Activity

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity
D000092202	Exercise-Induced Allergies

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C506613	oglemilast

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided