NCT00252291

Ability of Aridol to Detect Bronchial Hyperresponsiveness in Suspected Asthmatics

A Phase III Multicenter Study to Demonstrate the Sensitivity and Specificity of Aridol (Mannitol) Challenge to Predict Bronchial Hyperresponsiveness as Manifested by a Positive Exercise Challenge in Subjects Presenting With Signs and Symptoms Suggestive of Asthma But Without a Definitive Diagnosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (planned)
• Sponsor: Syntara · Industry
• Sex: All
• Age: 6 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3 study to determine the sensitivity and specificity of the Aridol bronchial challenge test to detect bronchial hyperresponsiveness in patients with suspected asthma. Patients with suspected asthma of either gender, aged between 6 and 50 years, with only mildly impaired lung function (FEV1 \>70%) are to be tested with three different bronchial hyperresponsiveness challenges (Aridol, exercise and methacholine), and the results compared. A clinical diagnosis will also be made at the end of the study.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Aridol
DRUG	Methacholine
PROCEDURE	Exercise challenge

Timeline

• Start date: 2005-11-01
• Completion: 2006-09-01
• First posted: 2005-11-11
• Last updated: 2009-12-01

Locations

1 site across 1 country: United States