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

Tracking Information

First Received Date ^ICMJE

November 20, 2006

Last Updated Date

November 20, 2006

Start Date ^ICMJE

August 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

status of airway inflammation after a 3 months treatment period
alveolar and bronchial exhaled nitric oxide

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

inflammatory markers in exhaled breath condensate
lung function parameters
symptoms / symptom free days
adverse effects

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: extrafine HFA-beclomethasone
Drug: HFA-fluticasone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

78 Months to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00402207

Responsible Party

Study ID Numbers ^ICMJE

MEC 05-005

Study Sponsor ^ICMJE

Maastricht University Medical Center

Collaborators ^ICMJE

AstraZeneca
Teva Global Respiratory Research LLC

Investigators ^ICMJE

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

Information Provided By

Maastricht University Medical Center

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP