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

Condition(s) targeted: Asthma

Intervention: extrafine HFA-beclomethasone (Drug); HFA-fluticasone (Drug)

Phase: N/A

Status: Completed

Sponsored by: Maastricht University

Official(s) and/or principal investigator(s):
Charlotte M Robroeks, MD, Principal Investigator, Affiliation: Maastricht University
Rijn Jöbsis, MD, PhD, Study Director, Affiliation: Maastricht University
Edward Dompeling, MD, PhD, Study Director, Affiliation: Maastricht University

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.

Official title: The Anti-Inflammatory Effect of Extrafine HFA-Beclometasone Versus HFA-Fluticasone, by Means of Exhaled Nitric Oxide, Inflammatory Markers in Exhaled Breath Condensate and Conventional Parameters

Study design: Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study

Primary outcome:

status of airway inflammation after a 3 months treatment period

alveolar and bronchial exhaled nitric oxide

Secondary outcome:

inflammatory markers in exhaled breath condensate

lung function parameters

symptoms / symptom free days

adverse effects

Minimum age: 78 Months. Maximum age: 12 Years. Gender(s): Both.

Criteria:

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

Exclusion Criteria:

- Instability of asthma during the past 3 months

- Presence of a disease that may intervene with the results of this study

- Active smoking

- Mental retardation

- Inability to perform the measurements properly

University Hospital Maastricht, Maastricht 6202 AZ, Netherlands

Starting date: August 2005
Ending date: October 2006
Last updated: November 20, 2006