EUCTR2015-001615-13-GB进行中（未招募）1 期
TARGETING OF THE SMALL AIRWAYS IN PATIENTS WITH COPD: AIRWAY EFFECTS OF TIOTROPIUM -Respimat vs. Handihaler - AIRWAY EFFECTS OF TIOTROPIUM IN PATIENTS WITH COPD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
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
入选标准
- •1) COPD patients with FEV1/FVC <70% predicted.
- •2) Mild (GOLD stage I: FEV1 >80% pred.) to moderate (GOLD stage II: FEV1 50-80% pred.)
- •3) Aged 30 years onwards – there is no upper age limit as we do not want to exclude elderly patients as COPD is primarily a disease in the elderly population.
- •4) Have ongoing symptoms or exercise limitation (determined by CAT score)
- •5) Stable COPD (no chest infection requiring antibiotics and/or oral steroids in the past 2 months).
- •6) Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1) We will not recruit subjects who lack the capacity to consent.
- •2) Current or past diagnosis of asthma.
- •3) Patients on concurrent LABAs or oral bronchodilators (theophylline, PDE4 inhibitors) will not be included.
- •4) History of any chronic respiratory diseases other than COPD.
- •5) History of another medical condition, which in the opinion of the Unit Physician, contraindicates his/her participation in the study.
- •6) Clinical evidence of heart failure (NYHA class III-IV).
- •7) Unstable respiratory disease in the last four weeks prior to the screening visit (indicated by any change in their maintenance inhaled therapy or who have had a lower respiratory tract infection in the previous four weeks).
- •8) Evidence of a respiratory exacerbation requiring emergency room treatment and/or hospitalisation within four weeks before screening.
- •9) Use of systemic (oral or intravenous) steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 12 months.
- •10) Participants with a known or suspected allergy, sensitivity or intolerance to the study drugs (this will be asked directly at the screening visit) or patients with a history of another drug allergy which, in the opinion of the Unit Physician, contraindicates his/her participation in the study.
- •11) Patient with a contraindication to taking an inhaled long-acting beta-agonists, listed in the British National Formulary (BNF).
- •12) Patients treated with beta-blockers in the week preceding the screening visit and during the study period.
- •13) Females who are pregnant or lactating or are likely to become pregnant during the trial. Women of childbearing potential may be included in the study if, in the opinion of the investigator, they are taking adequate contraceptive precautions.
- •14) Patients who have evidence of alcohol or substance abuse.
- •15) Participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit.
- •16) Contraindication to taking Tiotropium bromide
研究者
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