AsthmaNCT00402207
The Anti-Inflammatory Effect of Extrafine HFA-Beclometasone Versus HFA-Fluticasone, by Means of Inflammometry
A study testing extrafine HFA-beclomethasone and HFA-fluticasone in people with Asthma, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 78 months to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- extrafine HFA-beclomethasone and HFA-fluticasone
- How many people
- 33 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2005to Oct 2006
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 78 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- extrafine HFA-beclomethasone, HFA-fluticasone
- Keywords
- asthma, non-invasive inflammometry, exhaled nitric oxide, exhaled breath condensate, paediatric, extrafine HFA-beclomethasone, HFA-fluticasone
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extrafine HFA-beclomethasoneDrug
HFA-fluticasoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startAug 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Teva Branded
- Investigators
- Charlotte M Robroeks, MD, Principal investigator, Maastricht University Medical CenterRijn Jöbsis, MD, PhD, Study director, Maastricht University Medical CenterEdward Dompeling, MD, PhD, Study director, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402207
- Sponsor's protocol ID
- MEC 05-005
- Status last verified
- Sep 2005
- First submitted
- 20 Nov 2006
- Last updated
- 22 Nov 2006
- Results posted
- No