Efficacy and safety during 24 treatment weeks.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in trough level FEV1 in week 24 compared to baseline.
Secondary outcome
Change compared to baseline in number of days without rescue medication,
peakflow, symptom free days, asthma control, healthcare utilization, adverse
events, exacerbations.
Background summary
Inhaled steroids are, together with inhaled longacting β2-receptor agonists,
the cornerstones of bronchial asthma treatment. They are also marketed as
combinations.
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.
In this study efficacy and safety of once daily fluticasone furoate 50 mcg is
compared with the effects of a twice daily administration of fluticasone
propionate and placebo in adolescents and adults, who are presently not using a
corticosteroid. Since there are many adolescents with asthma, data on the
effects in the age group of 12 years and above are also collected in this
study. The dose of the inhaled corticosteroid in this age group is not
different from the dose in adults.
Study objective
Efficacy and safety during 24 treatment weeks.
Study design
Multicenter randomized double-blind double-dummy parallel group phase III
study.
Run-in period of 2 weeks. Thereafter randomization (1:1:1) to inhaled:
1. Fluticasone furoate (FF) 50 mcg once daily.
2. Fluticasone propionate (FP) 100 mcg twice daily.
3. Placebo.
24 treatment weeks.
Double dummy design because FF is provided in a new dry powderinhaler (Novel
Powder Inhaler) and FP in the well-known DISKUS (ACCUHALER).
Approx 330 randomized patients (approx 20 in NL).
Intervention
Treatment with fluticasone furoate or fluticasone propionate.
Study burden and risks
Risk: Adverse effects of study medication.
Burden: 8 visits en 3 phone calls in 27 weeks. All visits late in the afternoon
or evening.
Physical examination 2x.
Blood tests 2x (15-20 ml blood).
Optional pharmacogenetic tests (10 ml blood).
Pregnancy test (if indicated) 4x.
Pulmonary function test 8x (once incl. reversibility).
Peak flow measurements and completion of electronic diary daily 2x.
3 questionnaires (QoL, asthma control) 4x (time needed approx. 15 min).
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.
• Evening FEV1 of at least 60% of normal.
• At least 12% and at least 200 ml reversibility of FEV1.
• Current anti-asthma treatment: non-corticosteroid controller and/or short-acting bronchodilator.
• Females of childbearing potential: reliable method of contraception.
Exclusion criteria
• Life-threatening asthma within the last 10 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.
• 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; regsitratienummer n.n.b. |
| EudraCT | EUCTR2011-001900-36-NL |
| CCMO | NL37837.060.11 |