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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00402207
First Posted: November 22, 2006
Last Update Posted: November 22, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
AstraZeneca
Teva Branded Pharmaceutical Products, R&D Inc.
Information provided by:
Maastricht University Medical Center
  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
Intervention Model: Crossover Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   78 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00402207     History of Changes
Other Study ID Numbers: MEC 05-005
First Submitted: November 20, 2006
First Posted: November 22, 2006
Last Update Posted: November 22, 2006
Last Verified: September 2005

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:
Fluticasone
Anti-Inflammatory Agents
Beclomethasone
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists