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NCT06590740: EFFICIENCY
Establish FeNO Cut-off Value for Predicting Budesonide-formoterol Response in Chronic Cough Suggestive of CVA Patients.
Phase 4 trial testing Budesonide-Formoterol treatment in Cough-Variant Asthma in 1,000 participants. Completed in 3 September 2025.
3 September 2025
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 1,000 |
| Start date | 18 October 2024 |
| Primary completion | 3 September 2025 |
| Estimated completion | 3 September 2025 |
| Sites | 39 locations across China |
Drugs / interventions tested
- Budesonide-Formoterol treatment — full drug profile →
Conditions studied
- Cough-Variant Asthma — all drugs for Cough-Variant Asthma →
Sponsor
AstraZeneca — full company profile →
Who can join
18 and older, any sex, with Cough-Variant Asthma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06590740
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06590740 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
- Last refreshed: 18 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06590740.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing