A 24-week randomized, single blinded study in subjects with Chronic Obstructive Pulmonary Disease (COPD) to evaluate the effect of reminders and motivational/adaptive messages on treatment adherence tracked by the Concept2 inhaler

Phase 1

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
MedDRA version: 20.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2017-001593-42-NL

Lead Sponsor: ovartis Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 146

Inclusion Criteria

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
years).
4. A diagnosis of COPD confirmed by a post-bronchodilator FEV1 = 30% and < 80% of
the predicted normal value, and post-bronchodilator FEV1/FVC < 0.70 at some point
in the past 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

Exclusion Criteria

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 effective methods of contraception during the
study. Effective 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 defined as surgical hysterectomy, bilateral oophorectomy, or tubal
ligation at least six weeks before entering the study (Single oophorectomy does not meet
the definition of female sterilization).
• Male sterilization (at least 6 m 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, 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. 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.
• Placement of an intrauterine device (IUD) or intrauterine system (IUS).
• 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) 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.
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:
• anticholinergic agents
• long and short acting beta-2 agonists
• sympathomimetic amines
4. Subjects contraindicated for having a history of reactions/ hypersensitivity to lactose or any
of the other excipients of trial medication.
5. 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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