A multicenter, randomized, placebo-controlled, parallel group, 6-weeks study to evaluate the efficacy and safety of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 200 mcg/62.5 mcg/25 mcg Inhalation Powder on cough symptoms in adult patients with asthma

Tagaya Etsuko0 个研究点目标入组 60 人开始时间: 2021年11月8日最近更新: 2023年11月20日

研究概览

暂无简介。

•1)Participant must be 20 years of age or older, at the time of signing the informed consent.
•2)Outpatients who have subjective persistent-cough symptoms caused by asthma (minimum of 4 weeks of persistent-cough symptoms).
•3)Any inhaled corticosteroid (ICS) are not used within 6 weeks prior to Visit 1.
•4)No history of severe asthma exacerbation (severe asthma exacerbation by ATS/ERS definition: oral corticosteroid use and/or hospitalization or ED visit) within 12 weeks prior to Visit 1
•5)In the pulmonary function test and airway reversibility test on Visit 1, a pre-bronchodilator 60% =< FEV1 =< 90% of the predicted normal value at the Visit 1 OR Airway reversibility confirmed by >=12% and >=200 mL of improvement in post-bronchodilator FEV1.
•6)FeNO >=25 ppb at the Visit 1

•1)Current smokers OR Ex-smokers who quit smoking within 1 year of Visit 1 OR Ex-smokers with a smoking history of >10 pack-years.
•2)Subject with a history of life-threatening asthma attack within the last 10 years
•3)Subject with a respiratory tract infection or sinus infection that is not resolved by 8 weeks before Visit 1
•4)Subject with a current diagnosis of respiratory diseases other than asthma (e.g., COPD, bronchiectasis, interstitial lung disease, bronchopulmonary dysplasia)
•5)Subject with other causes of cough including symptomatic gastro-oesophageal reflux or symptomatic post nasal drip or COVID-19
•6)Subject has received any systemic steroid and/or antibiotics within 8 weeks prior to Visit 1
•7)Immunosuppressive medications: A subject must be using or require use of immunosuppressive medications during the study.
•8)Cytochrome P450 3A4 (CYP3A4) inhibitors: A Subject has received a potent CYP3A4 inhibitor within 4 weeks prior to Visit 1 (e.g., ritonavir, ketoconazole, itraconazole).
•9)PPI or antacids: A subject must be using or require use of PPI or antacids for dyspepsia during the study.
•10)ACE inhibitors: A subject must be using or require use of ACE inhibitors during the study.
•11)Biological products: A subject has received any biological product indicated for bronchial asthma within 12 weeks prior to Visit 1.

发起方

Tagaya Etsuko