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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00402207

Enrollment

Registered

2006-11-22

Start date

2005-08-31

Completion date

2006-10-31

Last updated

2006-11-22

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

Conditions

Asthma

Keywords

asthma, non-invasive inflammometry, exhaled nitric oxide, exhaled breath condensate, paediatric, extrafine HFA-beclomethasone, HFA-fluticasone

Brief summary

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.

Interventions

DRUGextrafine HFA-beclomethasone

DRUGHFA-fluticasone

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

78 Months to 12 Years

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

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

Design outcomes

Primary

Measure	Time frame
status of airway inflammation after a 3 months treatment period	—
alveolar and bronchial exhaled nitric oxide	—

Secondary

Measure	Time frame
inflammatory markers in exhaled breath condensate	—
lung function parameters	—
symptoms / symptom free days	—
adverse effects	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026