Use of Buventol Easyhaler and Bufomix Easyhaler as Relievers in Methacholine Challenge Testing and Inspiratory Flow Profiles During Induced Bronchoconstriction in Adult Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Forced expiratory volume in one second (FEV1)
研究概览
简要总结
The study compares Buventol® Easyhaler® and Bufomix® Easyhaler® to the current standard treatment during methacholine challenge test. The trial will also provide inspiratory flow profile data for Easyhaler inhaler.
This trial is designed to provide a further evidence for the use of Easyhaler in diagnostic bronchial challenge tests and on the use of Easyhaler inhaler during obstructive event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent (IC) obtained.
- •Finnish speaking adult (≥ 18 years old) subject indicated for methacholine challenge test.
- •The subject experiences FEV1 drop ≥ 20% compared to post-diluent spirometry.
排除标准
- •Subjects not eligible for methacholine challenge test for example for any of the following reasons:
- •Any respiratory infection within 2 weeks, or severe respiratory infection within 4 weeks before the study visit
- •FEV1 < 60% of predicted or < 1.0 l
- •Inability to perform acceptable and repeatable spirometry manoeuvres throughout the test procedure
- •Uncontrolled hypertension
- •Acute chest pain or unstable angina pectoris
- •Significant cardiac arrhythmias
- •Pneumothorax or recent bronchoscopy
- •Myocardial infarction or stroke in last 3 months
- •Known aortic aneurysm
- •Recent eye surgery or intracranial pressure elevation risk
- •Cholinesterase inhibitor medication
- •Pregnant or lactating females
- •Subjects who have used the following treatments before the study visit:
- •Short-acting β-agonists within 12 h
- •Long-acting β-agonists within 36 h
- •Ultra-long-acting β-agonists within 48 h
- •Long-acting anti-muscarinic agents within 168 h
- •Short-acting anticholinergics within 12 h
- •Oral theophylline within 24 h
- •Inhaled corticosteroids, leukotriene receptor antagonists and chromones within 4 weeks
- •Known hypersensitivity to the active substance(s) or the excipients of the study treatments (for example severe milk allergy, lactose contains small amounts of milk protein).
- •Administration of another investigational medicinal product within 30 days before the study visit.
研究组 & 干预措施
Buventol® Easyhaler® 200 µg/inhalation dmDPI
400 μg of salbutamol from Buventol Easyhaler is administered as two inhalations.
干预措施: Buventol® Easyhaler® 200 µg/inhalation dmDPI (Drug)
Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI
320 μg of budesonide and 9 μg of formoterol are administered from Bufomix Easyhaler as two inhalations.
干预措施: Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI (Drug)
Ventoline® Evohaler® 100 µg/inhalation pMDI
400 μg of salbutamol from Ventoline Evohaler is administered via Volumatic spacer as four inhalations.
干预措施: Ventoline® Evohaler® 100 µg/inhalation pMDI (Drug)
结局指标
主要结局
Forced expiratory volume in one second (FEV1)
时间窗: 10 minutes
Mean change in FEV1 from post-diluent to FEV1 after the first dose of reliever.
次要结局
- Number of subjects who recover from bronchoconstriction after first dose(10 minutes)
- Forced expiratory volume in one second (FEV1)(10 minutes)
- Number of subjects who recover from bronchoconstriction after second dose(20 minutes)