Breath test may predict who responds to common asthma drug for chronic cough

NCT ID NCT06590740

Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looked at 1000 adults with chronic dry or nighttime cough to find a cutoff value for a breath test called FeNO that can predict whether they will respond to the asthma medication budesonide-formoterol. Participants took the drug twice daily for 8 weeks, and their cough improvement was measured. The goal is to help doctors quickly identify patients who are likely to benefit from this treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Budesonide-formoterol (Symbicort)
What this could lead to: If successful, this could help doctors quickly identify which chronic cough patients are likely to benefit from budesonide-formoterol, improving treatment decisions.
What could go wrong: This is a completed study focused on finding a diagnostic cutoff, not testing a new treatment. The results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1,000 people

The number who actually took part.

Started

Oct 2024

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cough variant asthma Cough-Variant Asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cough variant asthma

Contacts and locations

Locations

Research Site

Beijing, 100029, China
Research Site

Beijing, 100034, China
Research Site

Benxi, 117000, China
Research Site

Chengdu, 610014, China
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Chengdu, 610041, China
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Chongqing, 400000, China
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Dongguan, CN-523326, China
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Fenyang, 032299, China
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Fuzhou, 350005, China
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Guangzhou, 510000, China
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Guangzhou, 510163, China
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Guangzhou, 510515, China
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Guiyang, 550002, China
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Heifei, 230011, China
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Heze, 274400, China
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Huizhou, 516002, China
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Jiaxing, 314001, China
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Jinhua, 321000, China
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Liuzhou, 545006, China
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Nanchang, 330006, China
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Nanjing, 211100, China
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Nanyang, 473000, China
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Quanzhou, 362000, China
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Shanghai, 201114, China
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Shanghai, 310000, China
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Shangqiu, 476100, China
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Shenzhen, 518020, China
Research Site

Shijiazhuang, 050001, China
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Suzhou, 657299, China
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Taiyuan, 030001, China
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Taiyuan, 030032, China
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Weifang, 261000, China
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Wenzhou, 325000, China
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Wenzhou, 325027, China
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Xi'an, 710006, China
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Xiangtan, 411228, China
Research Site

Yantai, 264000, China
Research Site

Zhengzhou, 450000, China
Research Site

Zunyi, 563100, China

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