EUCTR2010-023621-37-DE进行中（未招募）不适用
A 26-week treatment, multi-center, randomized, double-blind, double dummy, parallel-group study to assess the efficacy, safety and tolerability of QVA149 compared to fluticasone/salmeterol in patients with moderate to severe chronic obstructive pulmonary disease
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 522
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. Male or female adults aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
- •2. Patients with moderate to severe stable COPD (Stage II or Stage III) according to the GOLD Guidelines 2009.
- •3. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
- •4. Patients with a post-bronchodilator FEV1 =40% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (Day -14).
- •(Post refers to 1 hour after sequential inhalation of 84 µg (or equivalent dose) of ipratropium bromide and 400 µg of salbutamol)
- •5. Symptomatic patients, according to daily electronic diary data between Visit 2 (-14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days.
- •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. Pregnant women or nursing mothers (pregnancy confirmed by
- •positive urine pregnancy test).
- •2. Women of child-bearing potential (WOCBP) except under certain
- •circumstances (see protocol).
- •3. Patients contraindicated for treatment with, or having a history of
- •reactions/ hypersensitivity to any of the following inhaled drugs, drugs
- •of a similar class or any component thereof:
- •4. Patients with a history of long QT syndrome or whose QTc measured
- •at Visit 2 (Day -14) (Fridericia method) is prolonged (>450 ms for males
- •and females) as confirmed by the central ECG assessor.
- •5. Patients who have a clinically significant abnormality on the Visit 2
- •ECG who in the judgment of the investigator would be at potential risk if
- •enrolled into the study. (These patients should not be re-screened).
- •6. Patients with Type I or uncontrolled Type II diabetes.
- •7. Patients who have not achieved an acceptable spirometry result at
- •Visit 2 in accordance with ATS/ERS criteria for acceptability and
- •repeatability
- •8. Patients with narrow-angle glaucoma, symptomatic prostatic
- •hyperplasia or bladder-neck obstruction or moderate to severe renal
- •impairment or urinary retention. (Patients with a transurethral resection
- •of prostate (TURP) are excluded from the study. Patients who have
- •undergone full re-section of the prostate may be considered for the
- •study, as well as patients who are asymptomatic and stable on
- •pharmacological treatment for the condition).
- •9. Patients with a history of malignancy of any organ system (including
- •lung cancer), treated or untreated, within the past 5 years whether or
- •not there is evidence of local recurrence or metastases, with the
- •exception of localized basal cell carcinoma of the skin.
- •10. Patients who, in the judgment of the investigator, have a clinically
- •relevant laboratory abnormality or a clinically significant condition
- •11. Patients unable to use an electronic patient diary.
- •12. Patients who are, in the opinion of the investigator known to be
- •unreliable or non-compliant.
- •COPD specific exclusion
- •13. Patients requiring long term oxygen therapy on a daily basis for
- •chronic hypoxemia.
- •14. Patients who have had a COPD exacerbation that required treatment
- •with antibiotics, systemic steroids (oral or intravenous) or
- •hospitalization in the last year up to and including Visit 3.
- •15. Patients who have had a respiratory tract infection within 4 weeks
- •prior to Visit 1. Patients who develop an upper or lower respiratory tract
- •infection during the screening period (up to Visit 3) will not be eligible,
- •but will be permitted to be re-screened 4 weeks after the resolution of
- •the respiratory tract infection.
- •16. Patients with concomitant pulmonary disease, e.g. pulmonary
- •tuberculosis (unless confirmed by chest x-ray to be no longer active) or
- •clinically significant bronchiectasis, sarcoidosis, interstitial lung disorder
- •or pulmonary hypertension.
- •17. Patients with lung lobectomy, lung volume reduction, or lung
- •transplantation.
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研究者
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