Establish FeNO Cut-off Value for Predicting Budesonide-formoterol Response in Chronic Cough Suggestive of CVA Patients.
NCT ID: NCT06590740
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1000 participants
INTERVENTIONAL
2024-10-18
2025-09-03
Brief Summary
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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.
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Detailed Description
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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. Disclosure Statement: This is an Interventional study with single arm.
Number of Participants:
Approximately 1150 participants will be screened to achieve 1000, based on assuming a screen failure rate of approximately 15%. assigned to study intervention. Study Arms and Duration: Single-arm, 2 months Data Monitoring / Other Committee: Not applicable Statistical Methods： In general, descriptive statistics will be provided for the data collected. For continuous variables, mean, standard deviation, median, quartiles, minimum and maximum will be provided, and for categorical variables, frequency counts and percentages for each category will be provided. Missing data will not be imputed unless otherwise specified. The diagnostic value of FeNO to Budesonide-formoterol response will be measured as the area under the curve (AUC) of the receiver-operating characteristic derived from the Logistic regression model. The study is mainly to investigate if FeNO alone can help to distinguish patients with Budesonide-formoterol response or not, and therefore baseline FeNO value will be the only independent variable included in the model. The optimal cutoff value will be selected by consulting clinical experts, and based on comprehensive assessment of AUC, sensitivity, specificity, PPV, and NPV of different FeNO cut points. To perform discovery and validation within the same study, the total sample will be split randomly into discovery and validation datasets by 70% and 30% respectively. For the validation, similar parameters of diagnostic values will be calculated and compared with those based on the discovery dataset.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Budesonide-Formoterol treatment
Budesonide 160 μg/formoterol 4.5 μg, 1 inhalation, BID
Budesonide-Formoterol treatment
Budesonide 160 μg/formoterol 4.5 μg, 1 inhalation, BID
Interventions
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Budesonide-Formoterol treatment
Budesonide 160 μg/formoterol 4.5 μg, 1 inhalation, BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Kefang Lai
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Guangzhou Medical University
Locations
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Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Benxi, , China
Research Site
Chengdu, , China
Research Site
Chengdu, , China
Research Site
Chongqing, , China
Research Site
Dongguan, , China
Research Site
Fenyang, , China
Research Site
Fuzhou, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Guiyang, , China
Research Site
Heifei, , China
Research Site
Heze, , China
Research Site
Huizhou, , China
Research Site
Jiaxing, , China
Research Site
Jinhua, , China
Research Site
Liuzhou, , China
Research Site
Nanchang, , China
Research Site
Nanjing, , China
Research Site
Nanyang, , China
Research Site
Quanzhou, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shangqiu, , China
Research Site
Shenzhen, , China
Research Site
Shijiazhuang, , China
Research Site
Suzhou, , China
Research Site
Taiyuan, , China
Research Site
Taiyuan, , China
Research Site
Weifang, , China
Research Site
Wenzhou, , China
Research Site
Wenzhou, , China
Research Site
Xi'an, , China
Research Site
Xiangtan, , China
Research Site
Yantai, , China
Research Site
Zhengzhou, , China
Research Site
Zunyi, , China
Countries
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Other Identifiers
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D589BL00076
Identifier Type: -
Identifier Source: org_study_id
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