NCT06590740CompletedPhase 4
Establish FeNO Cut-off Value for Predicting Budesonide-formoterol Response in Chronic Cough Suggestive of CVA Patients.
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
Source: ClinicalTrials.gov · Last updated 18 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1000 (actual)
- First submitted
- 29 Aug 2024
- Start date
- 18 Oct 2024
- Primary completion date
- 3 Sept 2025
- Lead sponsor
- AstraZeneca
- Diseases
- Asthma
- NCT number
- NCT06590740
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 1000
- From 18 Oct 2024 to the primary completion date, 3 Sept 2025
- 32 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- 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.
Other
- Patients with suspected AECI induced cough.
- Intolerance to β2 agonists.
- Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.