EUCTR2017-001593-42-AT进行中（未招募）1 期
A 24-week randomized, controlled, multicenter, open-label study to evaluate the effect of reminder notifications and motivational/adaptive messaging on treatment adherence of COPD subjects receiving Ultibro® Breezhaler® treatment using the Concept2 inhaler for dose administration and tracking
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 146
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. Written informed consent must be obtained before any assessment is performed.
- •2. Male and female adults aged = 18 years.
- •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
- •4. A historical diagnosis of COPD confirmed by a post-bronchodilator
- •FEV1/FVC < 0.70 in the past and a pre-bronchodilator or postbronchodilator
- •FEV1 = 30% and < 80% of the predicted normal value
- •within the last year.
- •5. Have been taking Ultibro® Breezhaler® for at least 3 months prior to Visit 1 (in
- •accordance with the local product label).
- •6. Have a total adherence of more than 10% but less than or equal to 70% during
- •Screening period. Total adherence is defined as percentage of days on which the
- •subject inhaled a dose of Ultibro® Breezhaler®.
- •7. Have been in the Screening period = 35 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 116
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female
- •after conception and until the termination of gestation, confirmed by a positive hCG
- •(human Chorionic Gonadotropin) laboratory test.
- •2. Women of child-bearing potential, defined as all women
- •physiologically capable of becoming pregnant, unless they are using
- •basic methods of contraception while taking Ultibro® Breezhaler®
- •medication during the study. Basic contraception methods include:
- •Total abstinence (when this is in line with the preferred and usual
- •lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation,
- •symptothermal, post-ovulation methods) and withdrawal are not
- •acceptable methods of contraception.
- •Female sterilization (have had surgical bilateral oophorectomy with or
- •without hysterectomy), total hysterectomy, or tubal ligation at least six
- •weeks before taking study treatment. In case of oophorectomy alone,
- •only when the reproductive status of the woman has been confirmed by
- •follow up hormone level assessment.
- •Male sterilization (at least 6 months prior to screening). For female
- •subjects on the study, the vasectomized male partner should be the sole
- •partner for that subject.
- •Barrier methods of contraception: Condom or Occlusive cap
- •(diaphragm or cervical/vault caps). For UK: with spermicidal
- •foam/gel/film/cream/ vaginal suppository.
- •Use of oral, (estrogen and progesterone), injected or implanted
- •hormonal methods of contraception or other forms of hormonal
- •contraception that have comparable efficacy (failure rate < 1%), for
- •example hormone vaginal ring or transdermal hormone contraception or
- •placement of an intrauterine device (IUD) or intrauterine system (IUS).
- •In case of use of oral contraception, women should have been stable on
- •the same pill for a minimum of 3 months before entering the study.
- •Women are considered post-menopausal and not of child bearing
- •potential if they have had 12 months of natural (spontaneous)
- •amenorrhea with an appropriate clinical profile (e.g. age appropriate,
- •history of vasomotor symptoms) or have had surgical bilateral
- •oophorectomy (with or without hysterectomy), total hysterectomy or
- •tubal ligation at least six weeks ago. In the case of oophorectomy alone,
- •only when the reproductive status of the woman has been confirmed by
- •follow up hormone level assessment is she considered not of child
- •bearing potential.
- •If local regulations deviate from the contraception methods listed above
- •to prevent pregnancy, local regulations apply and will be described in
- •3. Subjects 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:
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