Primary: efficacy and safety of the addition of UMEC 62.5mcg once daily to ICS/LABA therapy, compared with placebo over 12 weeks in subjects with COPD.Secondary: effect of the addition of UMEC to ICS/LABA therapy on COPD-related health status…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Trough FEV1 on day 85, Incidence of adverse events.
Secondary outcome
Main: Weighted mean 0-6 hour FEV1 obtained post-dose on Treatment Day 84.
Background summary
COPD is a major cause of poor health, poor quality of life and is resulting in
millions of deaths annually worldwide.
The cornerstone of treatment are longacting B2-agonists (LABA) and inhaled
corticosteroids ICS). Salbutamol is used in case of dyspnea. In case of
insufficient treatment effect, a longacting muscarinic antagonist (LAMA) is
added.
Umeclidinium bromide (UMEC) is a LAMA (dry powder formulation) that has
recently been registered in the EU for the treatment of COPD under the name
Incruse.
In this study in subjects with COPD the efficacy and safety of UMEC is
investigated when added to a LABA and an ICS.
Study objective
Primary: efficacy and safety of the addition of UMEC 62.5mcg once daily to
ICS/LABA therapy, compared with placebo over 12 weeks in subjects with COPD.
Secondary: effect of the addition of UMEC to ICS/LABA therapy on COPD-related
health status assessments over 12 weeks in subjects with COPD.
Study design
Multi-center, Randomized Double-blind Parallel Group, Placebo-Controlled
Double-Blind phase IV Trial.
Randomization (1:1) to
* UMEC 62,5 mcg once daily.
* Placebo once daily.
Dry powder formulation; in addition to standard treatment with a longacting
B2-agonist and an inhaled corticosteroid (twice daily).
Treatment duration 13 weeks.
Study duration approx. 15 weeks.
Approx. 230 patients.
Intervention
Treatment with UMEC or placebo.
Study burden and risks
Risk: adverse events of study treatment.
Burden: 8 study visits plus one final phone call. Duration 1-6h.
Physical examination, pregnancy test, questionnaires (2) 3 times.
Pulmonary function tests: plus reversibility once; single time point 3 visits;
multiple time points (6 tests, predose plus up to 6 h post dose) 3 visits.
ECG once.
Paper diary for medical problems plus therapy, use of study medication, other
COPD medication, rescue medication.
Optional pharmacogenetic testing (saliva).
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Listed location countries
Age
Inclusion criteria
* 40 years of age or above.
* An established clinical history of COPD in accordance with the definition by the ATS/ERS.
* Current or former cigarette smokers with a history of cigarette smoking of *10 pack-years (see protocol page 26 for details).
* Pre and post-salbutamol FEV1/FVC ratio of <0.70 and post-salbutamol FEV1 of *70% of predicted.
* Must be on the dose and frequency of one of the ICS/LABA combinations approved for COPD and for the study at least 30 days prior screening (see protocol page 26-27 for details).
* Score of *2 on the mMRC.
* Females of childbearing potential: adequate method of contraception. See protocol page 26 for details.
Exclusion criteria
* Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
* Lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1.
* Unstable or life threatening cardiac disease. See protocol page 27-28 for details.
* Defined prior therapies. See protocol page 28-29 for details.
* Pregnancy or breastfeeding
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Clinicaltrials.gov; registratienummer n.n.b. |
| EudraCT | EUCTR2014-000611-14-NL |
| CCMO | NL49073.060.14 |