NCT01256086已完成2 期
Relative Potency of Formoterol Novolizer® 12 µg Compared to Formoterol Aerolizer® 12 µg in Patients With Stable Asthma Using Bronchoprovocation With Methacholine as a Bioassay Randomized, Double-blind, Four-period, Four-sequence Cross-over Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- PC20 = Provocation Concentration of Methacholine That Cause a 20% Decrease in Forced Expiratory Volume in the First Second (FEV1)
研究概览
简要总结
The purpose of this study is to estimate the relative potency for bronchoprotective effect of formoterol Novolizer 12 µg (test) compared to formoterol Aerolizer 12 µg (reference).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged from 18 to 60 years (inclusive).
- •Patients with asthma indicated by
- •history of asthma symptoms and
- •airway hyperresponsiveness to methacholine with a provocation concentration of methacholine that cause a 20% decrease in FEV1 (PC20) ≤8 mg/ml at Visit
- •Patients with stable asthma condition with baseline forced expiratory volume in the first second (FEV1) ≥70% predicted at first visit.
- •The PC20 methacholine should increase at least 4-fold after inhaling 24 μg of formoterol Aerolizer (2 applications of 12 μg) at Visit
- •Able to be taught correct inhalation technique for both devices at screening.
排除标准
- •Known hypersensitivity to formoterol, lactose, or methacholine.
- •History of life-threatening asthma in the last three years.
- •Major malignancies including pheochromocytoma within the last 5 years. Exception will be considered where malignancies have been resolved as judged by investigator.
- •Pregnancy, breast-feeding, planned pregnancy during the study, or women of child-bearing potential not using adequate contraception. These methods include total abstinence (no sexual intercourse), oral contraceptives, an intrauterine device (IUD), an etonogestrel implant (Implanon), or medroxyprogesterone acetate injections (Depo-Provera shots). If one of these cannot be used, using contraceptive foam and a condom are recommended.
- •Lack of suitability for the study:
- •Screening visit 2 has to be postponed repeatedly.
- •Evidence of respiratory tract infection within 4 weeks before the study (screening visit 1).
- •Seasonal or episodic exposure to an allergen or occupational chemical sensitizer which are likely to vary in symptom presentation and severity during the course of the study (e.g. ragweed sensitive patients in Iowa during Aug-Oct). This does not apply to patients who can be well controlled on therapy.
- •History of non-reversible pulmonary disease; chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, or pulmonary fibrosis.
- •History of severe cardiovascular, renal, neurologic, liver or endocrine dysfunction (patients with well-controlled hypertension, hypercholesterolemia, thyroid disease or diabetes may be included if medication for these diseases does not affect methacholine challenge or formoterol metabolism).
- •History of hemophilia or coagulation disease.
- •Electrocardiogram (ECG) abnormalities of clinical relevance, in particular abnormal prolongation of QT-interval (QTc according to Bazett in women ≥450 msec, in men ≥430 msec).
- •Potassium level below lower limit of laboratory normal range plus 0.3 mmol/l as safety margin.
- •Exacerbation of bronchial asthma requiring emergency department visit or hospitalization during the last 3 months prior to this study.
- •Prior or concomitant treatment with systemic glucocorticosteroids during the last 3 months (a short course of oral corticosteroids for asthma is permissible if for <10 days and at least 30 days have passed).
- •Use of long-acting ß2-agonists in last 3 weeks before the first methacholine challenge or during the study
- •Change in dosage of other controller therapy (inhaled glucocorticosteroids, leukotriene modifier, slow-release theophylline) during the last 3 weeks before the first methacholine challenge or during the study.
- •Use of short-acting ß2-agonists more than thrice a week in the previous month.
- •Inability to temporary withhold the following medications/substances before lung function test:
- •short-acting ß2-agonists and short-acting anticholinergics at least 6 hours,
- •regular long-acting ß2-agonists at least 3 weeks,
- •long-acting anticholinergics at least 36 hours,
- •inhaled glucocorticosteroids at least 2 hours
- •Disodium cromoglycate (DSCG) at least 24 hours,
- •slow release theophylline at least 48 hours,
- •rapid release theophylline at least 24 hours,
- •caffeine at least 4 hours
- •Patients with aspirin induced bronchospasm.
- •Any treatment with ß2-antagonists (including eye drops).
- •Non-cooperative patients, inability to perform outcome measurement correctly.
- •Inability to measure PC20 methacholine after 24 μg of formoterol Aerolizer (PC20 >128 mg/ml).
- •Current smokers or regular smokers during last 12 months or more than 10 pack-year history.
- •Drug or alcohol abuse which would interfere with the patient's proper completion of the protocol assignment.
- •Administrative reasons:
- •Participation in another clinical study within 1 month prior to or during this study
- •Lack of ability or willingness to give informed consent.
- •Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.
- •Personnel involved in the planning or conduct of the study.
- •Anticipated non-availability for study visits/procedures.
研究组 & 干预措施
24 µg Formoterol Novolizer
Experimental
12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
干预措施: Formatris 24µg (Drug)
12µg Formoterol Novolizer
Experimental
12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
干预措施: Formatris 12µg (Drug)
24 µg Formoterol Aerolizer
Active Comparator
Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
干预措施: Foradil P 24µg (Drug)
12µg Formoterol Aerolizer
Active Comparator
Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
干预措施: Foradil P 12µg (Drug)
结局指标
主要结局
PC20 = Provocation Concentration of Methacholine That Cause a 20% Decrease in Forced Expiratory Volume in the First Second (FEV1)
时间窗: 60 min after application of study medication
The primary variable is the methacholine PC20 after inhalation of study medication; the PC20 is the concentration of methacholine that - despite protection by study medication - causes a 20% fall in FEV1 compared to the pre-methacholine (post-saline) level of the given study day.
次要结局
未报告次要终点
研究者
研究点 (3)
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