Status:
COMPLETED
Establish FeNO Cut-off Value for Predicting Budesonide-formoterol Response in Chronic Cough Suggestive of CVA Patients.
Lead Sponsor:
AstraZeneca
Conditions:
Cough-Variant Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Subjects who voluntarily participate in the study and comply with the study requirements, understand, comply with and cooperate with the corresponding examinations, comply with the follow-up schedule, and voluntarily sign the written informed consent form.
- Patients aged ≥ 18 years.
- Subjects with cough as the predominant or sole symptom, and manifested as dry or nocturnal cough lasting for ≥ 8 weeks.
- FEV1/FVC ≥ 70% within 4 weeks from the enrolment.
- No clinically significant abnormality in the chest CT within 3 months from the enrolment.
- Cough VAS score ≥ 40 mm measured within 48 hours before enrollment.
Exclusion
- Any history of respiratory infection within 8 weeks from the enrolment.
- Dyspnea caused by respiratory system disorders.
- Patients with GERC, upper airway cough syndrome/postnasal drip syndrome as the likely cause of cough.
- Patients with suspected AECI induced cough.
- Intolerance to β2 agonists.
- Used ICS-containing drugs within 8 weeks before enrollment, including ICS or ICS/LABA and so on.
- Used oral corticosteroids within 8 weeks before enrollment.
- Used LTRA within 8 weeks before enrollment.
- Current smokers, or former smokers with a smoking cessation interval of less than 6 months; Smokers with a pack history of greater than 20 pack-years.
- Individuals with severe respiratory or other systemic diseases.
- Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator.
Key Trial Info
Start Date :
October 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06590740
Start Date
October 18 2024
End Date
September 3 2025
Last Update
September 18 2025
Active Locations (39)
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1
Research Site
Beijing, China, 100029
2
Research Site
Beijing, China, 100034
3
Research Site
Benxi, China, 117000
4
Research Site
Chengdu, China, 610014