Primary: To evaluate the efficacy of FF/UMEC/VI to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD. Secondary: Long term safety and other efficacy parameters.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rate of exacerbations.
Secondary outcome
FEV1, St George questionnaire, time to first exacerbation. Adverse events.
Background summary
Inhaled corticosteroids, long-acting ß2-agonists (LABA) and long-acting
muscarinic receptor antagonists (LAMA) are essential drugs for the treatment of
COPD. This triple therapy is widely used; in the US in over 25% of COPD
patients. Various clinical trials have shown the benefits of the addition of a
third drug (LABA or LAMA).
Fluticasone furoate (FF) is an inhaled corticosteroid, umeclidinium (UMEC) is a
LAMA and vilanterol is a LABA. The sponsor is currently developing these three
drugs in a once daily fixed combination as a dry powder for inhalation for the
treatment of more severe COPD (Gold D).
Study objective
Primary: To evaluate the efficacy of FF/UMEC/VI to reduce the annual rate of
moderate and severe exacerbations compared with dual therapy of FF/VI or
UMEC/VI in subjects with COPD.
Secondary: Long term safety and other efficacy parameters.
Study design
Multicenter randomized double blind phase III parallel group study. Run-in
period of 2 weeks.
Randomization (2:2:1) to treatment with:
* FF/UMEC/VI (100/62,5/25 mcg) once daily
* FF/VI (100/25 mcg) once daily
* UMEC/VI (62.5/25 mcg) once daily
administration as inhaled dry powder formulation.
Treatment duration 52 weeks.
Safety follow-up of 1 week.
Approx 10.000 randomized patients.
Intervention
Treatment with FF/UMEC/VI, FF/VI or UMEC/VI.
Study burden and risks
Risk: Adverse effects of study medication. Worsening COPD due to
discontinuation of current medication.
Burden:
7 visits and 1 phone call in 1 year. Duration 3-4 hours.
Physical examination: 3 times.
Blood draw 15 ml 5 times.
ECG 4 times.
Pulmonary function test + reversibility every visit.
Chest X-ray (if not performed in past 3 months) once.
Pregnancy test (if relevant) 6 times.
Questionnaires (4) 4-5 times.
Daily completion of electronic and paper diary.
Optional pharmacogenetic research (6 ml blood once.
Huis ter Heideweg 62
Zeist 3705LZ
NL
Huis ter Heideweg 62
Zeist 3705LZ
NL
Listed location countries
Age
Inclusion criteria
* COPD patients *40 years of age.
* (Ex) smokers, at least 10 pack years.
* Post salbutamol FEV1/FVC ratio <0,70.
* A score of *10 on the COPD Assessment Test (CAT).
* Post-bronchodilator FEV1 < 50% predicted normal and a documented history of * 1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator 50% *FEV1 < 80% predicted normal and a documented history of * 2 moderate exacerbations or a documented history of *1 severe COPD exacerbation (hospitalized) in the previous 12 months.
* Safe contraception for women of childbearing potential.
Exclusion criteria
* Pregnancy, lactation.
* Risk factors for pneumonia (see protocol page 33 for details).
* Abnormal Chest x-ray (see protocol page 33 for details).
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 | EUCTR2013-003075-35-NL |
| CCMO | NL48046.060.14 |