Primary: Efficacy of FF/GW642444 100/25 mcg once daily in comparison with that of FP/salmeterol 250/50 mcg twice daily during 24 weeks.Secundary: Safety and tolerability.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
FEV1 0-4 h and at trough level.
Secondary outcome
Questionnaires quality of life, asthma control, healthcare utilization, adverse
events, cortisol excretion.
Background summary
Inhaled longacting *2-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 is a new glucocorticoid, being developed as an inhalation
powder (in a newly designed inhaler. Preclinical and clinical tests indicate a
longer duration of action in comparison with fluticasone propionate (marketed
as Flixotide); so once daily dosing seems realistic. There is a need for once
daily administration in order to improve treatment compliance and thus asthma
control.
GW642444M is a potent, longacting *2-receptor agonist.
In this study efficacy and safety of the once daily combination fluticasone
furoate and GW642444M is compared with the effects of a twice daily
administration of fluticasone propionate and the longacting *2-agonist
salmeterol (Seretide).
Study objective
Primary: Efficacy of FF/GW642444 100/25 mcg once daily in comparison with that
of FP/salmeterol 250/50 mcg twice daily during 24 weeks.
Secundary: Safety and tolerability.
Study design
Multicenter randomized double-blind double-dummy parallel Group phase III
study.
Discontinuation of current asthma treatment. Run-in period of 4 weeks
fluticasone propionate and salbutamol. Thereafter randomization (1:1) to:
1. Fluticasone furoate/GW642444 100/25 mcg once daily.
2. Fluticasone propionate/salmeterol 250/50 mcg twice daily.
24 treatment weeks.
Approx 820 randomized patients (approx 1640 to screen).
Intervention
Treatment with fluticasone furoate/GW642444 or fluticasone
propionate/salmeterol.
Study burden and risks
Risk: Adverse events of study medication. Discontinuation of current asthma
treatment.
Burden: 6 visits and 3 telephone calls in 24 weeks, incl. 2 long measurement
days of 4 and 24 h. Overnight stay in hospital for 24 h measurements. All
visits start between 5 and 9 pm.
Pulmonary function tests: at screening incl. reversibility. At 1st dose of
study medication 8 tests in 1st 4 h. Last dose 17 tests in 24 h (incl.
measurements during night). Other visits 1 test.
Blood tests 3x (approx 4-10 ml/visit, approx 20 ml in total). Optional
pharmacogenetic study (10 ml of blood).
Physical examination 1x, ECG 1x, pregnancy test 3x, Astma control test 3x. AQLQ
and EQ-5D questionnaires 2x.
Huis ter Heideweg 62
3705 LZ Zeist
NL
Huis ter Heideweg 62
3705 LZ Zeist
NL
Listed location countries
Age
Inclusion criteria
* Age 12 years and above.
* Bronchial asthma (acc. to NIH), at least 12 weeks.
* Evening FEV1 of 40-85%.
* At least 12% and at least 200ml reversibility of FEV1.
* Inhaled corticosteroid for at least 12 weeks and be maintained on a medium dose (e.g. FP 250 mcg twice daily) for at least the last 4 weeks.
* 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. Use of inhaled tobacco products within the past 3 months.
* Pregnancy or breastfeeding.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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 nog niet bekend |
| EudraCT | EUCTR2010-019589-10-NL |
| CCMO | NL32720.098.10 |