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Establish FeNO Cut-off Value for Predicting Budesonide-formoterol Response in Chronic Cough Suggestive of CVA Patients.

CompletedPhase 4

Sponsor: AstraZeneca

Conditions: Cough-Variant Asthma

Interventions: Budesonide-Formoterol treatment

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (39)

Beijing, China
Beijing, China
Benxi, China
Chengdu, China
Chengdu, China
Chongqing, China
Dongguan, China
Fenyang, China
Fuzhou, China
Guangzhou, China
Guangzhou, China
Guangzhou, China
Guiyang, China
Heifei, China
Heze, China
Huizhou, China
Jiaxing, China
Jinhua, China
Liuzhou, China
Nanchang, China
Nanjing, China
Nanyang, China
Quanzhou, China
Shanghai, China
Shanghai, China
Shangqiu, China
Shenzhen, China
Shijiazhuang, China
Suzhou, China
Taiyuan, China
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