Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252291
Status:
COMPLETED
Last Update Posted:
2009-12-01
First Post:
2005-11-10
Brief Title:
Ability of Aridol to Detect Bronchial Hyperresponsiveness in Suspected Asthmatics
Sponsor:
Syntara
Organization:
Syntara
Study Overview
Official Title:
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
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None