Primary: To demonstrate non-inferiority of RELVAR 100/25 once-daily to SERETIDE 250/50 twice-daily in adult and adolescent subjects 12 years of age and older with persistent asthma,adequately controlled on twice-daily ICS/LABA. Secondary: Adverse…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change from baseline in clinic visit evening FEV1 (pre-bronchodilator and
pre-dose) at the end of the 24-week treatment period.
Secondary outcome
Percentage of rescue-free and symptom-free 24-hour periods during the study,
peak flow, asthma control test, adverse events, exacerbations.
Background summary
RELVAR ELLIPTA (fluticasone furoate/vilanterol inhalation powder) is a inhaled
corticosteroid (ICS)/long-acting beta2 agonist (LABA) combination for oral
inhalation administered from a dry powder inhaler approved in several countries
including the EU for the treatment of asthma and COPD. In a number of countries
including the EU the asthma indication is limited to patients not adequately
controlled with inhaled corticosteroids and 'as needed' inhaled short acting
beta2-agonists. The indication does not currently include patients already
adequately controlled on both an ICS and LABA (also known as a substitution
indication).
Obtaining a substitution indication would allow patients controlled with a
twice daily ICS/LABA (as a combination product or via separate inhalers) to be
switched to once daily RELVAR ELLIPTA, which would simplify their treatment
regimen and encourage treatment compliance. This would also make the asthma
indication for RELVAR approved in the EU and some other countries consistent
with other approved ICS/LABA combinations in those countries. In order to
support a substitution indication this study will determine if once daily
RELVAR 100/25 is non-inferior to twice-daily SERETIDE (fluticasone
propionate/salmeterol) 250/50 in adult and adolescent asthmatic subjects
already adequately controlled on a twice-daily ICS/LABA. Fluticasone propionate
250 has been included as an active comparator for assay sensitivity.
Study objective
Primary: To demonstrate non-inferiority of RELVAR 100/25 once-daily to SERETIDE
250/50 twice-daily in adult and adolescent subjects 12 years of age and older
with persistent asthma,
adequately controlled on twice-daily ICS/LABA.
Secondary: Adverse events, exacerbations.
Study design
Randomised, double-blind, double-dummy, parallel-group phase III
non-inferiority study.
LABA washout 5 days. 4 week run-in period on SERETIDE 250/50 mcg twice daily.
Randomisation (1:1:1) to
* RELVAR ELLIPTA 10/25 mcg once daily for 24 weeks
* SERETIDE 250/50 mcg twice daily for 24 weeks
* FLIXOTIDE 250 mcg twice daily for 24 weeks.
Salbutamol rescue medication.
Follow-up: 1 week.
Approx. 1460 patients.
Intervention
Treatment with RELVAR, SERETIDE or FLIXOTIDE.
Study burden and risks
Risk: adverse events of study treatment.
Burden: 7 visits and 1 telephone call in 30 weeks. Duration 1-3 h.
Physical examination once.
Pregnancy test 4 times.
Pulmonary function test 7 times. Once incl. reversibility.
Peak expiratory flow twice daily.
Twice completion of 2 questionnaires.
Paper and electronic diary. Asthmatic complaints, rescue medication, other
complaints and medication and level of exercise.
Optional pharmacogenetic testing (saliva)
Huis te Heideweg 62
Zeist 3705 LZ
NL
Huis te Heideweg 62
Zeist 3705 LZ
NL
Listed location countries
Age
Inclusion criteria
* Outpatients *12 years of age with asthma (NIH 2007) for at least 12 weeks.
* Pre-bronchodilator FEV1 of *80% of the predicted normal value.
* Mid dose ICS plus LABA (equivalent to FP/salmeterol 250/50 twice daily or an equivalent combination via separate inhalers) for at least the 12 weeks immediately preceding Visit 1.
* In the opinion of the investigator the subject*s asthma is well controlled.
* Adequate contraception for females of childbearing potential (see protocol page 24-25 for details).
Exclusion criteria
* Life-Threatening Asthma within the last 5 years. See protocol page 25 for details.
* Respiratory infections, other concurrent diseases. See protocol page 25-26 for details.
* Severe milk protein allergy.
* Concomitant medications as listed in section 6.10 of the protocol.
* Immunosuppressive therapy.
* Current smokers or former smokers with a smoking history of *10 pack years.
* 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 | EUCTR2014-002253-19-NL |
| CCMO | NL50556.060.14 |