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OpenTrials
Completed

NCT Number: NCT00322686

Study of Oglemilast for the Treatment of Asthma

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Forest Investigative Site

Los Angeles, California, 90025, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oglemilast

Drug

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

Placebo then Oglemilast

Drug

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

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

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

Efficacy and Safety of Oglemilast in the Prevention of Allergen-induced Bronchospasm

Important dates

Study start
2006
Primary completion
2006
First posted
May 8, 2006
Registry last updated
Mar 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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