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

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Teva Branded Pharmaceutical Products, R&D Inc.
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00402207
First received: November 20, 2006
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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.


Condition Intervention
Asthma
Drug: extrafine HFA-beclomethasone
Drug: HFA-fluticasone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

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

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

Estimated Enrollment: 33
Study Start Date: August 2005
Estimated Study Completion Date: October 2006
  Eligibility

Ages Eligible for Study:   78 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402207

Locations
Netherlands
University Hospital Maastricht
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
AstraZeneca
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Principal Investigator: Charlotte M Robroeks, MD Maastricht University Medical Center
Study Director: Rijn Jöbsis, MD, PhD Maastricht University Medical Center
Study Director: Edward Dompeling, MD, PhD Maastricht University Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00402207     History of Changes
Other Study ID Numbers: MEC 05-005
Study First Received: November 20, 2006
Last Updated: November 20, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
asthma
non-invasive inflammometry
exhaled nitric oxide
exhaled breath condensate
paediatric
extrafine HFA-beclomethasone
HFA-fluticasone

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Beclomethasone
Nitric Oxide
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents

ClinicalTrials.gov processed this record on April 17, 2014