Bronchial asthma
Conditions
Interventions
Investigational drug group dosage: FF/UMEC/VI 200 mcg/62.5 mcg/25 mcg is administered by inhalation once daily for 6 weeks
Placebo group dosage: Placebo of FF/UMEC/VI is administered by inhalation onc
Sponsors
Tagaya Etsuko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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% ==12% and >=200 mL of improvement in post-bronchodilator FEV1. 6)FeNO >=25 ppb at the Visit 1
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in cough symptoms score over Week-6 (eDaily Diary) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Cough symptoms score (eDaily Diary), weekly mean changes from baseline (Week 1-5) - Cough severity score (eDaily Diary), weekly mean changes from baseline (Week 1-6) - Cough frequency score (eDaily Diary), weekly mean changes from baseline (Week 1-6) - Night-time awakenings score (eDaily Diary), weekly mean changes from baseline (Week 1-6) - Mean change from baseline in Leicester Cough Questionnaire (LCQ) at Week 3 and 6 - Mean change from baseline in Asthma Control Questionnaire (ACQ)-7/6/5 at Week 1, 3 and 6 - % change from baseline in weekly rescue salbutamol use (number of inhalations) - % rescue salbutamol free days during treatment period (Day 1-42) - Mean change from baseline in Asthma Control Test (ACT) at Week 6 - Daily or weekly mean changes from baseline in morning/evening peak expiratory flow (PEF) (eDaily Diary) during treatment period (Day 1-42) - Daily or weekly mean changes from baseline in morning/evening forced expiratory volume in 1 second (FEV1) (eDaily Diary) during treatment period ( Day 1-42) - Mean % change from baseline in FeNO at Week 1, 3 and 6 - Weekly changes from baseline in the proportion of days with a night-time awakenings score (eDaily Diary) of 0 - Proportion of subjects with a night-time awakenings score (eDaily Diary) of 0 on Week 1, Week 3 and Week 6 - Subgroup analyses stratified by airway reversibility, %FEV1, FeNO and Blood eosinophil counts | — |
Contacts
Public ContactEtsuko Tagaya
Tokyo Women's Medical University
Outcome results
None listed