Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 20.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Ultibro Breezhaler
Product Name: indacaterol maleate/glycopyrronium
Product Code: QVA149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: indacaterol maleate
CAS N
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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 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 wil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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;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.;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;Timepoint(s) of evaluation of this end point: The secondary endpoint is evaluated at week 24 of the interventional phase | — |
Countries
Austria, Belgium, Czech Republic, Germany, Ireland, Netherlands, United Kingdom
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed