The Anti-Inflammatory Effect of Extrafine HFA-Beclometasone Versus HFA-Fluticasone, by Means of Inflammometry

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Asthma

Treatments

Drug: extrafine HFA-beclomethasone

Drug: HFA-fluticasone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00402207

MEC 05-005

Details and patient eligibility

About

Background Chronic inflammation in peripheral airways plays an important role in the pathophysiology of asthma. Extrafine hydrofluoroalkane (HFA) beclometasone is distinguished from other ICS because of its fine aerosol characteristics. As a result, there is a greater extent of deposition of extrafine HFA-beclometasone in the peripheral airways. Therefore, extrafine HFA-beclometasone may have an extra anti-inflammatory effect in children with asthma.

Aim To analyse the potential extra anti-inflammatory effect of extrafine HFA-beclometasone compared to HFA-flucticasone in children with asthma by means of alveolar nitric oxide (NO) concentration and bronchial NO flux, inflammatory markers in exhaled breath condensate (EBC), and conventional parameters.

Method In a cross-over study design of 6 months, 33 children, aged 6-12 years, with doctor diagnosed mild persistent asthma, were treated with extrafine HFA-beclometasone inhaled from an autohaler and HFA-flucticasone inhaled from a discus. Primary outcome parameters of this study were; alveolar NO concentration and bronchial NO flux. Secondary outcome parameters were inflammatory markers in EBC, lung function parameters, symptoms, presence and duration of exacerbations and adverse effects. All parameters were recorded at baseline and after each treatment period.

Sex

All

Ages

78 months to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age 6.5 - 12 years
children with mild-persistent asthma
treatment with inhaled corticosteroids(≤ 500 μg HFA-Flucticasone, ≤ 800 μg Budesonide, or ≤ 800 μg HFA-Beclometasone, daily)
allowed, but needed to be used during the entire study period;
- short / long-acting β2-agonists
- leukotrien receptor antagonists
- antihistamines