Establish FeNO Cut-off Value for Predicting Budesonide-formoterol Response in Chronic Cough Sugge… (NCT06590740) | Clinical Trial Compass
CompletedPhase 4
Establish FeNO Cut-off Value for Predicting Budesonide-formoterol Response in Chronic Cough Suggestive of CVA Patients.
China1,000 participantsStarted 2024-10-18
Plain-language 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 ICS/LABA treatment is defined as reduction in cough VAS score from baseline of ≥30 mm after 8 weeks of ICS/LABA treatment. Subjects will be treated with Symbicort® 160/4.5 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
To obtain a cut-off value for FeNO which can be used to distinguish responsiveness to 8 weeks treatment of Budesonideformoterol (based on visual analog scale [VAS]).