Primary: to compare the efficacy and safety of once daily (evening) administration of FF/VI 100/25 with FF 100 in adult and adolescent subjects >= 12 years of age with moderate to severe, persistent bronchial asthma over 12 weeks.Secondary:…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Weighted mean serial FEV1 over 0-24 hours post-dose at the end of the treatment
period.
Secondary outcome
Major secondary variables: Change from baseline in the percentage of
symptom-free 24-hour periods during the treatment period, change from baseline
in AM and PM PEF averaged over the treatment period, adverse events,
exacerbations, candidiasis.
Background summary
Inhaled long acting β2-receptor agonists and inhaled steroids are the
cornerstones of bronchial asthma treatment. They are also marketed as
combinations. The current combinations must be dosed twice daily.
Fluticasone furoate (FF)/Vilanterol (VI) is a combination of a glucocorticoid
and a long-acting beta2-agonist (LABA) currently under development for use as a
once daily inhaled treatment for asthma and COPD. International guidelines
advocate the use of inhaled LABAs in combination with ICS as maintenance
therapy for asthmatics who remain symptomatic on low- to mid-doses of ICS. The
availability of a once daily ICS/LABA treatment would be expected to improve
patient compliance and, consequently, improve asthma control.
Current asthma guidelines also suggest that for patients not adequately
controlled on low or medium dose ICS combined with a LABA, *stepping up* to a
higher dose of the ICS in the combination product may be warranted. Thus, it is
clinically important to identify patients who may benefit from the higher
strength ICS/LABA combination product.
Study objective
Primary: to compare the efficacy and safety of once daily (evening)
administration of FF/VI 100/25 with FF 100 in adult and adolescent subjects >=
12 years of age with moderate to severe, persistent bronchial asthma over 12
weeks.
Secondary: relative efficacy of Fluticasone Furoate/Vilanterol 200/25mcg and
Fluticasone Furoate/Vilanterol 100/25.
Study design
Multicenter randomized double-blind parallel group phase III study.
Discontinuation of current asthma treatment. Run-in period 4 weeks. Thereafter
randomization (1:1:1) to:
1. FF/VI Inhalation Powder 200/25 once daily in the evening
2. FF/VI Inhalation Powder 100/25 once daily in the evening
3. FF 100 Inhalation Powder once daily in the evening
Salbutamol rescue medication.
Study duration max. 17 weeks (run-in max. 4 w, treatment 12 w, follow-up 1 w).
Approx 990 randomized patients.
Intervention
Treatment with fluticasone furoate/ Vilanterol or fluticasone furoate.
Study burden and risks
Risk: Adverse events of study medication. Discontinuation of current asthma
treatment.
Burden: 8 visits in 17 weeks, incl. 1 long measurement day of 24 h. All visits
start between 4 and 5 PM.
Physical examination 2x.
Blood tests (17,5 ml) 2x.
Pulmonary function tests: at screening incl. reversibility. 3x 1 test. 14 tests
during visit 7 in 24 h.
It may be necessary for practical reasons to arrange an overnight stay for the
patiënt for the day with 24h measurements. In principle this will not be in the
hospital, but in an accomodation nearby. For this reason qustion E3 has been
answered in a negatively.
Daily peak flow AM and PM.
ECG 1x.
Pregnancy test 1-2x.
Diary completion daily.
Questionnaires 5x.
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Listed location countries
Age
Inclusion criteria
• Age 12 years and above.
• Bronchial asthma (acc. to NIH), at least 12 weeks.
• Best FEV1 of 40-80% (pre-bronchodilator). See protocol page 19 for details.
• At least 12% and at least 200ml reversibility of FEV1.
• Inhaled corticosteroid for at least 12 weeks. See protocol page 20 for details.
• Females of childbearing potential: reliable method of contraception.
Exclusion criteria
• Life-threatening asthma within the last 5 years.
• Respiratory infection within the last 4 weeks.
• Asthma exacerbation within the last 12 weeks.
• Visual evidence of candidiasis.
• History of severe milk protein allergy.
• Potent CYP3A4 inhibitor within the last 4 weeks.
• Current smoker or a smoking history of 10 pack years. No inhaled tobacco products within the past 3 months.
• Previous use of FF/VI of FF in another phase III study.
• 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 | EUCTR2012-002797-32-NL |
| CCMO | NL41863.060.12 |