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Determining FeNO Levels to Predict Cough Treatment Response

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

Not applicable Interventional AstraZeneca · NCT06590740

This study is testing if measuring a specific gas in your breath can help predict how well a common asthma medication will work for people with a long-lasting cough.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Locations40 sites (Beijing and 39 other locations)
Trial IDNCT06590740 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, single-arm clinical study aims to establish a cut-off value for fractional exhaled nitric oxide (FeNO) to predict the response to budesonide-formoterol treatment in patients suffering from chronic dry or nocturnal cough. Participants will receive Symbicort® for 8 weeks, with their cough severity measured before and after treatment. The study will involve approximately 1000 patients across 40 sites in China, focusing on those with cough symptoms lasting at least 8 weeks and no other identifiable causes. Data will be collected at multiple visits to assess treatment efficacy based on cough reduction.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic dry or nocturnal cough lasting at least 8 weeks and no other obvious causes for their symptoms.

Not a fit: Patients with cough caused by conditions such as gastroesophageal reflux disease or upper airway cough syndrome may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a reliable method for predicting which patients will benefit from budesonide-formoterol treatment for chronic cough.

How similar studies have performed: While this approach is novel in establishing FeNO cut-off values for this specific treatment, similar studies have shown promise in predicting treatment responses in asthma management.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 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.
2. Patients aged ≥ 18 years.
3. Subjects with cough as the predominant or sole symptom, and manifested as dry or nocturnal cough lasting for ≥ 8 weeks.
4. FEV1/FVC ≥ 70% within 4 weeks from the enrolment.
5. No clinically significant abnormality in the chest CT within 3 months from the enrolment.
6. Cough VAS score ≥ 40 mm measured within 48 hours before enrollment.

Exclusion Criteria:

1. Any history of respiratory infection within 8 weeks from the enrolment.
2. Dyspnea caused by respiratory system disorders.
3. Patients with GERC, upper airway cough syndrome/postnasal drip syndrome as the likely cause of cough.
4. Patients with suspected AECI induced cough.
5. Intolerance to β2 agonists.
6. Used ICS-containing drugs within 8 weeks before enrollment, including ICS or ICS/LABA and so on.
7. Used oral corticosteroids within 8 weeks before enrollment.
8. Used LTRA within 8 weeks before enrollment.
9. 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.
10. Individuals with severe respiratory or other systemic diseases.
11. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator.

Where this trial is running

Beijing and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cough-Variant Asthma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.