Double-blind, placebo-controlled, parallel group, study of ICS/LABA/LAMA on cough symptoms in adult patients with asthma
- Conditions
- Bronchial asthma
- Registration Number
- JPRN-jRCTs031210412
- Lead Sponsor
- Tagaya Etsuko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change from baseline in cough symptoms score over Week-6 (eDaily Diary)
- Secondary Outcome Measures
Name Time Method