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NCT Number: NCT00402207

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

78 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Maastricht

Maastricht, 6202 AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

extrafine HFA-beclomethasone

Drug

HFA-fluticasone

Drug

Primary outcomes

  1. status of airway inflammation after a 3 months treatment period

  2. alveolar and bronchial exhaled nitric oxide

Secondary outcomes

  1. inflammatory markers in exhaled breath condensate

  2. lung function parameters

  3. symptoms / symptom free days

  4. adverse effects

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • AstraZeneca
  • Teva Branded

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2006
First posted
Nov 22, 2006
Registry last updated
Nov 22, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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