Clinical trial NCT00402207: The Anti-Inflammatory Effect of Extrafine HFA-Beclometasone Versus HFA-Fluticasone, by Means of Inflammometry
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma
non-invasive inflammometry
exhaled nitric oxide
exhaled breath condensate
paediatric
extrafine HFA-beclomethasone
HFA-fluticasone
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Teva Branded
First posted: 2006-11-22
Enrollment: 33
Sex: ALL
Minimum age (years): 78
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: status of airway inflammation after a 3 months treatment period
measure: alveolar and bronchial exhaled nitric oxide
Secondary outcomes:
measure: inflammatory markers in exhaled breath condensate
measure: lung function parameters
measure: symptoms / symptom free days
measure: adverse effects
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
Study officials:
affiliation: Maastricht University Medical Center
name: Charlotte M Robroeks, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Rijn Jöbsis, MD, PhD
role: STUDY_DIRECTOR
affiliation: Maastricht University Medical Center
name: Edward Dompeling, MD, PhD
role: STUDY_DIRECTOR
References: