E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Obstructive Pulmonary Disease (COPD) |
|
E.1.1.1 | Medical condition in easily understood language |
COPD is a chronic condition of the lungs which causes people to suffer
symptoms such as shortness of breath and coughing.
|
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010952 |
E.1.2 | Term | COPD |
E.1.2 | System Organ Class | 100000004855 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the effect of dose tracking in conjunction with reminder notifications and motivational/adaptive messages sent by the patient application over 24 weeks on the subject’s on-time treatment adherence
and therefore treatment behavior
(1) the effect of the intervention on the on-time treatment adherence of the subjects
(2) the effect of the intervention on the total treatment adherence of the subjects |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the effect of dose tracking in conjunction with reminder notifications and
motivational/adaptive messages sent by the patient application over 24 weeks on the subject’s
On-time adherence over the last four weeks of the Interventional period
Total adherence over the last four weeks of the Interventional period |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 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. |
|
E.4 | Principal 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
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:
• 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
exception of localized basal cell carcinoma of the skin.
6. 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.
7. Subjects who have had a COPD exacerbation that required treatment with antibiotics and/or
systemic corticosteroids and/or hospitalization in 6 weeks prior to Visit 1.
8. Subjects who develop a COPD exacerbation between screening (Visit 1) and prior to
intervention (Visit 110) will not be eligible but will be permitted to be re-screened after a
minimum of 6 weeks after the resolution of the COPD exacerbation.
9. Subjects who have had a respiratory tract infection within 3 weeks prior to Visit 1.
10. Subjects who develop a respiratory tract infection between screening (Visit 1) and prior to
intervention (Visit 110) will not be eligible, but will be permitted to be re-screened 3 weeks
after the resolution of the respiratory tract infection.
For full list please see protocol |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Co-primary endpoint 1: on- time adherence defined as percentage of days on which the subject inhaled a t least one
dose within (±) 2 hours of the agreed preferred daily inhalation time (PIT).
Co-primary objective 2: total adherence defined as percentage of days on which the subject inhaled at least one
dose and represents the sum of on-time adherence and off-time adherence.
Off-time adherence is defined as percentage of days on which the subject inhaled a dose of
medication, but did not do so within the target window (±) 2 hours of the agreed PIT. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
· On-time adherence over the last four weeks of the Interventional period
· Total adherence over the last four weeks of the Interventional period |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
The secondary endpoint is evaluated at week 24 of the interventional phase |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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 tracking |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
treat. arm with investigational software application vs control arm with no software |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 45 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |