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

NCT00402207 | Completed

• 1 other identifier: MEC 05-005
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• status of airway inflammation after a 3 months treatment period

• alveolar and bronchial exhaled nitric oxide

Secondary Outcomes (4)

• inflammatory markers in exhaled breath condensate

• lung function parameters

• symptoms / symptom free days

• adverse effects

Interventions

extrafine HFA-beclomethasone DRUG

HFA-fluticasone DRUG

Eligibility Criteria

• Age: 78 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• AstraZeneca: collaborator
• Teva Branded: collaborator

Study Sites (1)

University Hospital Maastricht

Maastricht, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Charlotte M Robroeks, MD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

• Rijn Jöbsis, MD, PhD

  Maastricht University Medical Center

  STUDY DIRECTOR

• Edward Dompeling, MD, PhD

  Maastricht University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2006
• First Posted: November 22, 2006
• Study Start: August 1, 2005
• Study Completion: October 1, 2006
• Last Updated: November 22, 2006

Record last verified: 2005-09

Locations

NL (1)