Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590740
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Establish FeNO Cut-off Value for Predicting Budesonide-formoterol Response in Chronic Cough Suggestive of CVA Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Establishment of a FeNO Cutoff Value for Evaluating the Response to Budesonide-formoterol in Patients With Chronic Cough Suggestive of Cough Variant Asthma a Multicenter Prospective Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
EFFICIENCY
Brief Summary:
This is a multicenter prospective single-arm interventional clinical study to predict the response to budesonide-formoterol treatment in patients with chronic dry or nocturnal cough by determining a cut off value of FeNO In this study the response to ICSLABA treatment is defined as reduction in cough VAS score from baseline of 30 mm after 8 weeks of ICSLABA treatment Subjects will be treated with Symbicort 16045 mcg 1 puff BID for 8 weeks with 4 study visits Visit 1 Day 0 Visit 2 week 4 and Visit 3 end of study week 8 and Visit 4 4 weeks after treatment discontinuation week 12 Baseline data will be collected at Day-5 to Day0
This study will be conducted at around 40 study sites in China Approximately 1000 patients age 18 years old with dry cough or nocturnal cough symptoms for at least 8 weeks and no other obvious cause for their cough will be enrolled into this study
This study will be conducted at around 40 study sites in China Approximately 1000 patients age 18 years old with dry cough or nocturnal cough symptoms for at least 8 weeks and no other obvious cause for their cough will be enrolled into this 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