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 - CIDD001D2402 (ADVICE)

ovartis0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月15日

试验速览

阶段: 3 期
状态: 已完成
发起方: ovartis
入组人数: 20

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•- Signed informed consent must be obtained prior to participation in the study.
•- Male and female adults aged * 18 years.
•- 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).
•- A historical diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC <
•0.70 in the past and a pre-bronchodilator or post-bronchodilator FEV1 * 30% and < 80%
•of the predicted normal value and post-bronchodilator FEV1/FVC < 0.70 at some point
•within the last year.
•- Have been taking Ultibro® Breezhaler® for at least 3 months prior to Visit 1 (in accordance with the local product label).
•- 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®.
•- Have been in the Screening period * 35 days.

排除标准

•- 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.
•- 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).
•* 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 the ICF.
•- 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:
•* anticholinergic agents
•* long and short acting beta-2 agonists
•* sympathomimetic amines
•- Subjects contraindicated for having a history of reactions/ hypersensitivity to lactose or any of the other excipients of trial medication.
•- Subjects with a history of malignancy of any organ system, 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.
•- Subjects with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. Benign Prostatic Hyperplasia (BPH) subjects who are stable on treatment can be considered.

研究者

发起方

ovartis

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