JPRN-jRCTs041220003进行中（未招募）未知
Real-life effectiveness of Indacaterol/Glycopyrronium/Mometasone for symptomatic relief of cough after switching from ICS/LABA therapy in patients with asthma
iimi Akio0 个研究点目标入组 212 人开始时间: 2022年4月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 212
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •1. Patients whose written consent has been obtained prior to the initiation of any procedure related to this study.
- •2. Male or female, between 20 and 80 years of age at the time of consent.
- •3. Patients must have a diagnosis record of asthma at least 3 months prior to Visit 0.
- •4. Patients who have been receiving moderate doses of FF/VI or BUD/FM for at least one month prior to Visit 0.
- •5. Patients with a cough VAS (awake) of 40 mm or greater at both Visit 0 and Visit 1 (or Visit 1 pre).
- •6. Patients who are willing to not receive SMART therapy during the study period.
排除标准
- •1. Patients who have smoked (including e-cigarettes) within 12 months prior to Visit 0, or who have smoked at least 10 pack-years in the past (Note: 1 pack is equivalent to 20 cigarettes. 10 pack-year = 1 pack/day x 10 years, or 1/2 pack/day x 20 years).
- •2. Patients who quit smoking within 6 months prior to Visit 0.
- •3. Patients who have used central antitussives within 1 months prior to Visit 0. (e.g Codeine phosphate, etc.)
- •4. Patients who have used antitussive herbal medicines within 1 months prior to Visit 0.
- •5. Patients who have used amitriptyline for neuropathic pain treatment or antitussive purposes within 3 months prior to Visit 0. (Examples opioids, gabapentin, pregabalin, etc.)
- •6. Patients who have used ACE inhibitors within 3 months prior to Visit 0.
- •7. Patients who have used anticholinergic drugs (LAMA, SAMA, oral drugs) and tricyclic antidepressants or first-generation antihistamine with anticholinergic effects within 1 months prior to Visit 0.
- •8. Patients who started or changed controllers for asthma except medium-dose ICS/LABA within 1 months prior to Visit 0. (However, patients who started or changed anti-IgE, anti-IL-5, anti-IL-5 receptor alpha, anti-IL-4 receptor alpha, or anti-TSLP antibody preparations within 3 months prior to Visit 0 are excluded.)
- •9. Patients who received SMART therapy within 3 months prior to Visit 0.
- •10. Patients with upper or lower respiratory tract infections or significant changes in lung function within 1 month prior to Visit 0 or from Visit 0 to the date of administration (Visit1).
- •11. Patients with abnormal findings on chest radiographs taken within 12 months prior to Visit 0 that could cause cough.
- •12. Patients with a history of chronic lung diseases other than asthma. These chronic lung diseases include (but are not limited to) chronic obstructive pulmonary disease (COPD), sarcoidosis, interstitial lung disease, cystic fibrosis, bronchiectasis, and active infections such as pulmonary tuberculosis.
- •13. Patients with a history of malignancy under treatment.
- •14. Patients with angle closure glaucoma.
- •15. Patients with dysuria due to prostatic hypertrophy, etc.
- •16. Patients who cannot or are not willing to use the electronic diary record device.
- •17. Patients participating in interventional trials (including clinical trials) other than this study.
- •18. Patients who are pregnant, lactating or may be pregnant.
- •19. Patients who have previously experienced a safety issue with the study drug or any of its active ingredients.
- •20. Other patients who are judged by the principal investigator or sub-investigator to be inappropriate as research subjects.
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