EUCTR2007-005135-28-DE进行中（未招募）不适用
A randomised, double–blind, crossover efficacy and safety comparison of Tiotropium/Salmeterol (7.5 µg/ 25 µg) Inhalation Powder in the morning (PE Capsule via tiotropium/salmeterol HandiHaler®), Tiotropium (18 µg) Inhalation Powder in the morning (gelatine capsule via Spiriva® HandiHaler®), Salmeterol (50 µg) Multi-Dose Powder Inhaler in the morning and evening and the free combination Tiotropium (18 µg) Inhalation Powder in the morning (gelatine capsule via Spiriva® HandiHaler®) plus Salmeterol (50 µg) Multi-Dose Powder Inhaler in the morning and evening following chronic administration (6-week treatment periods) in patients with COPD - Comparison of Tiotropium/Salmeterol Inhalation Powder (PE capsule) with the marketed mono products
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •1.) All patients must sign an informed consent consistent with ICH-GCP guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions.
- •2.) All patients must have a diagnosis of COPD and must meet the following criteria:
- •relatively stable* airway obstruction with a post-bronchodilator FEV1 < 80% of predicted normal and post-bronchodilator FEV1 < 70% of post-bronchodilator FVC at
- •Visit 1 (according to GOLD criteria)
- •* The randomisation of patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period should be postponed. Patients may be randomised 6 weeks following recovery from the infection or exacerbation. Predicted normal values will be calculated according to ECSC: For height measured in metres
- •FEV1 predicted (L) = 4.30 x [height (metres)] – 0.029 x age (years) – 2.49
- •FEV1 predicted (L) = 3.95 x [height (metres)] - 0.025 x age (years) – 2.60
- •3.) Male or female patients 40 years of age or older.
- •4.) Patients must be current or ex-smokers with a smoking history of = 10 pack-years
- •(patients who have never smoked cigarettes must be excluded).
- •5.) Patients must be able to perform technically acceptable pulmonary function tests
- •during the study period as required in the protocol (including the PEF and FEV1
- •measurements with the electronic peak flow meter AM2+).
- •6.) Patients must be able to inhale medication in a competent manner from the
- •HandiHaler® devices and the multi-dose powder inhaler
- •7.) Patients must be able to perform all necessary recordings in the AM2+.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.) Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may either put the patient at risk because of participation in the study or may influence either the results of the study or the patient’s ability to participate in the study.
- •2.) Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion
- •3.) Patients with a recent history (i.e., six months or less) of myocardial infarction.
- •4.) Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the past year.
- •5.) Hospitalisation for cardiac failure during the past year.
- •6.) Malignancy for which the patient has undergone resection, radiation therapy or
- •chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
- •7.) Patients with a history of asthma or who have a total blood eosinophil count =
- •600/mm3. A repeat eosinophil count will not be conducted in these patients.
- •8.) Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
- •9.) Known active tuberculosis.
- •10.) Patients with a history (within the past two years) of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1.
- •11.) Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1.
- •12.) Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study.
- •13.) Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator’s opinion will be unable to abstain from the use of oxygen therapy.
- •14.) Patients who have taken an investigational drug within 30 days or six half-lives
- •(whichever is greater) prior to Screening Visit (Visit 1).
- •15.) Use of antihistamines (H1 receptor antagonists), anti-leukotrienes or leukotriene
- •receptor antagonists for asthma or excluded allergic conditions. See exclusion criterion No 7.
- •16.) Use of cromolyn sodium or nedocromil sodium.
- •17.) Use of systemic corticosteroid medication at unstable doses (i.e., less than six weeks on stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
- •18.) Known hypersensitivity to anticholinergic drugs, ß2-adrenergic drugs, lactose or any other component of the study medication delivery systems.
- •19.) Pregnant or nursing women
- •20.) Women of childbearing potential not using a highly effective method of birth control.
- •Highly effective methods of birth control are defined as those which result in a low
- •failure rate (i.e. less than 1% per year) when used consistently and correctly such as
- •implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or
- •vasectomised partner. Female patients will be considered to be of childbearing
- •potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or
- •post-menopausal for at least two years.
- •21.) Treatment with oral beta-adrenergics within 4 weeks prior to Screening Visit (Visit 1) or during the 2-week run-in period.
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