EUCTR2013-002517-35-DE进行中（未招募）不适用
Bronchodilator properties and safety of a repeated dose of V0162 inhalation powder in asthma
Pierre Fabre Médicament/Institut de Recherche Pierre Fabre0 个研究点开始时间: 2013年7月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria (checked on Visit 1):
- •-Male or female gender.
- •-Aged 18 to 65 years-old.
- •-18 = BMI <30 kg/m².
- •-Clinical history consistent asthma, in the judgement of the investigator.
- •-Asthma controlled or partly controlled according to GINA 2012 criteria:
- •Less than three of the following items present over the last week:
- •1)daytime symptoms more than twice a week,
- •2)any limitation of activities,
- •3)any nocturnal symptoms/awakening,
- •4)need of reliever/rescue treatment more than twice a week
- •-Asthma treated by ICS and LABA (fixed-dose combination or free combination) at stable dose for at least 3 months.
- •-Able to replace the usual ICS and LABA therapy by ICS at the usual dose regimen and salbutamol as needed.
- •-Able to stop salbutamol at least 6 hours before a study visit.
- •-Able to perform at least 3 acceptable and reproducible FEV1 and FVC measurements according to ERS/ATS 2005 recommendations.
- •-For woman of child bearing potential: negative urine or serum pregnancy test at inclusion and using an efficient contraceptive (surgical or hormonal birth control or intra-uterine device) for at least 2 months before the study and one month after the end of the study, in order to avoid pregnancy while being exposed to the study treatment.
- •-Having signed the Informed Consent Form.
- •-Likely to be compliant during the study, in the judgement of the investigator.
- •-Affiliated to the social security system or being a beneficiary.
- •Inclusion criteria (checked on Visit2):
- •-No use of salbutamol within the last 6 hours.
- •-No use of ultra long-acting Beta2-agonist (indacaterol) and/or long-acting muscarinic-antagonists within the last 48 hours.
- •-No use of xanthines or antileukotrienes within the last week.
- •-No use of oral and/or intravenous corticosteroids within the last 4 weeks.
- •-No use of depot and/or intramuscular corticosteroids within the last 6 months.
- •-No use of antihistamines within the last week.
- •-Pre-bronchodilation FEV1= 60% of the predicted normal value.
- •-Reversibility demonstrated by a FEV1 increase =12% ((FEV1 post-bronchodilation – FEV1 pre-bronchodilation) / FEV1 pre-bronchodilation) and = 0.200 L (FEV1 post-bronchodilation – FEV1 pre-bronchodilation), 10-20 minutes after acute administration of 4x100 µg salbutamol.
- •Inclusion criteria (checked on Visits 3 and 5):
- •-Asthma controlled or partly controlled according to GINA 2012 criteria:
- •Less than three of the following items present over the last week:
- •1)daytime symptoms more than twice a week,
- •2)any limitation of activities,
- •3)any nocturnal symptoms/awakening,
- •4)need of reliever/rescue treatment more than twice a week, considering salbutamol use as reliever if intake exceeds 4 times 2 inhalations per day (taking into account LABA being replaced by salbutamol)
- •Stability criterion (checked on Visits 5, 7 and 9):
- •-Difference of the measured FEV1 (L) value compared to the previous measurement = 30% (Visit 5 vs Visit 3, Visit 7 vs Visit 5, Visit 9 vs Visit 7)
- •If a patient fails to meet that stability criterion, the respective visit may be rescheduled twice.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Non-inclusion criteria (checked on Visit 1)
- •Criteria related to pathologies
- •-History of aspirin intolerance or aspirin-induced asthma.
- •-History of life-threatening asthma within 5 years (i.e., brittle asthma or requiring hospitalisation in ICU).
- •-Clinically significant respiratory conditions other than asthma (e.g. pneumonia, pneumothorax, atelectasis, bronchiectasis, chronic bronchitis, COPD, emphysema, pulmonary arterial hypertension, pulmonary fibrosis,etc.).
- •-Upper or lower respiratory tract infection within 4 weeks.
- •-Exacerbation (requiring oral corticosteroids or hospitalization) within 3 months.
- •-Current smoker or former smoker less than 6 months or total lifetime smoking history greater than 10 pack-years.
- •-Intolerance to salbutamol.
- •-Intolerance to tiotropium (or any other atropine-derived compound).
- •-Intolerance to one of the ingredients of the study product: mequitazine (and more generally all phenothiazine-derived compounds) and lactose.
- •-Severe hepatic impairment, moderate to severe renal impairment, epilepsy, narrow angle glaucoma, moderate to severe prostatic hypertrophy, bladder neck obstruction.
- •-Any acute or chronic disease that will not allow the participation in the study, in the judgement of the investigator.
- •-Clinically relevant physical examination abnormality.
- •-Abnormal vital signs (SBP > 140 or < 90 mmHg; DBP > 90 or < 60 mmHg; HR > 100 or < 40 bpm in supine position, unless decision of the Investigator).
- •-Abnormal and clinically significant 12-lead ECG (HR > 100 or < 40 bpm, PR > 220 or < 100 ms, QRS > 120 ms, QTcF > 450 ms).
- •-Congenital long QT syndrome, known or suspected prolongation of QT interval (QTcF > 450 ms), heart failure, hypokalemia, family history of Long QT syndrome, use of concomitant medications that prolong the QT/QTc interval.
- •-Clinically relevant biological (haematology, biochemistry and urinary) exam abnormality, in particular hypokalemia.
- •Criteria related to the population
- •-Pregnancy or in post-partum period or nursing mother.
- •-Alcohol abuse (more than 28 units (male) or 21 units (female) of alcohol a week (unit = 1 glass of wine = 1 glass of spirits = ½ pint of beer)).
- •-Drug abuse.
- •-Positive serology to HIV antibodies, HCV antibodies and/or HBs antigen.
- •-Patients who cannot maintain regular day/night, waking/sleeping cycles (e.g. night shift workers).
- •-Patients who are not able to understand the information (for linguistic or psychiatric reasons), in the judgement of the investigator.
- •-Patients who had forfeited their freedom by administrative or legal decision, or who are under guardianship or wardship.
- •-Patients who cannot be contacted by phone in an emergency.
- •-Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Selection Visit (Visit 1)
研究者
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