A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids (FFA115285)

A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids (FFA115285) - FFA115285

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37429

Enrollment

Registered

2011-08-19

Start date

2011-12-14

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma bronchial asthma

Interventions

Treatment with fluticasone furoate or fluticasone propionate.

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Change in trough level FEV1 in week 24 compared to baseline.	—

Secondary

Measure	Time frame
Change compared to baseline in number of days without rescue medication, peakflow, symptom free days, asthma control, healthcare utilization, adverse events, exacerbations.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)