Primary:To evaluate the effects of FF/UMEC/VI on lung function compared with FF/VI after 24 weeks of treatmentSecondary:To assess the efficacy (exacerbations), FEV1 3h post dose, asthma symptoms, safety and tolerability.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Trough FEV1 at week 24.
Secondary outcome
Annualized rate of moderate/severe asthma exacerbations. FEV1 3h post dose
(week 24), Mean change from baseline in ACQ-7, SGRQ, total score at Week 24.
Mean change from baseline in Evaluating Respiratory Symptoms (E-RS) total score
over the first 24 weeks of the treatment period. Adverse effects.
Background summary
Inhaled corticosteroids, long-acting ß2-agonists (LABA) and long-acting
muscarinic receptor antagonists (LAMA) are essential drugs for the treatment of
more severe asthma.
Fluticasone furoate (FF) is an inhaled corticosteroid, umeclidinium (UMEC) is a
LAMA and vilanterol (VI) 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 asthma.
This new study has been designed in order to assess the effects of FF/UMEC/VI
in subjects with insufficiently controlled asthma. The effects of 4 dosages of
this combination will be compared to 2 dosages of the registered combination of
FF/VI.
FF/UMEC/VI can be dosed once a day, thus improving treatment compliance.
Study objective
Primary:
To evaluate the effects of FF/UMEC/VI on lung function compared with FF/VI
after 24 weeks of treatment
Secondary:
To assess the efficacy (exacerbations), FEV1 3h post dose, asthma symptoms,
safety and tolerability.
Study design
Double blind multicenter parallel group study. Run-in period (Seretide) 3
weeks, stabilization period (FF/VI) 2 weeks, treatment period minimum 24 and
maximum 52 weeks (dependent on the moment of randomization), follow-up period 1
week. Randomization (1:1:1:1:1:1) to once daily
* FF/UMEC/VI 100 mcg/62,5 mcg/25 mcg
* FF/UMEC/VI 200 mcg/31,25 mcg/25 mcg
* FF/UMEC/VI 100 mcg/31,25 mcg/25 mcg
* FF/UMEC/VI 200 mcg/62,5 mcg/25 mcg
* FF/VI 100 mcg/25 mcg
* FF/VI 200 mcg/25 mcg
2.250 subjects.
Intervention
Treatment with 1 of 4 dosages FF/UMEC/VI or 1 of 2 dosages FF/VI.
Study burden and risks
Risk: Adverse events of the study medication. Worsening of asthma due to
changes in medication.
Burden:
8-10 visits in 32-60 weeks.
Based on 60 study weeks:
Physical examination: 3 times.
Blood draws: 4 times (15 ml blood).
Pregnancy test: 8 times.
Pulmonary function tests: 8 times (1-2 tests per occasion).
FeNO test onze.
ECG: 4 times.
Entire study period: 1. Daily FEV1/PEF measurements, 2. Diary symptoms and
escape medication and 3. Diary adverse events, changes in medication, visits to
other MDs.
Questionnaires: ACQ-5 weekly, others 4-6 times.
Optional: blood sample for pharmacogenetics, PK sampling day (4 samples in 3
h).
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Listed location countries
Age
Inclusion criteria
* Inadequately controlled asthma (ACQ-6 score *1.5) at Visit 2.
* A best pre-bronchodilator morning (AM) FEV1 *30% and <85% of the predicted normal value at Visit 2. Predicted values will be based upon the ERS Global Lung Function Initiative.
Exclusion criteria
* Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject*s asthma status or the subject*s ability to participate in the study.
* Evidence of a severe exacerbation during screening or the run-in period, defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days (1) or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
(1) For subjects on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required.
* Changes in asthma medication (excluding run-in medication and salbutamol inhalation aerosol provided at Visit 1).
* 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 |
|---|---|
| EudraCT | EUCTR2016-001304-37-NL |
| Other | http://www.gskclinicalstudyregister.com, nummer 205715 |
| CCMO | NL58477.100.16 |