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
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 20.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2017-001593-42-AT
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 146
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 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
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
the ICF.
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:
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