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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402207
• Other study ID #: MEC 05-005
• Status: Completed
• Phase: N/A
• First received: November 20, 2006
• Last updated: November 20, 2006
• Start date: August 2005
• Est. completion date: October 2006

Study information

• Verified date: September 2005
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 78 Months to 12 Years

Eligibility

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 ß2-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

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• extrafine HFA-beclomethasone

• HFA-fluticasone

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht	Maastricht

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	AstraZeneca, Teva Branded Pharmaceutical Products, R&D Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	status of airway inflammation after a 3 months treatment period
Primary	alveolar and bronchial exhaled nitric oxide
Secondary	inflammatory markers in exhaled breath condensate
Secondary	lung function parameters
Secondary	symptoms / symptom free days
Secondary	adverse effects