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”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: extrafine HFA-beclomethasone
• Drug: HFA-fluticasone

Primary Measures

• status of airway inflammation after a 3 months treatment period
• alveolar and bronchial exhaled nitric oxide

Secondary Measures

• inflammatory markers in exhaled breath condensate
• lung function parameters
• symptoms / symptom free days
• adverse effects

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 78 Months

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Maastricht University

Overall Clinical Trial Officials and Contacts

Charlotte M Robroeks, MD Principal Investigator Maastricht University  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00402207

Study ID Number: MEC 05-005

ClinicalTrials.gov Identifier: NCT00402207

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)