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
- Are there results?
- None posted in the registry
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.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00402207
- Acronym / sponsor ID
- MEC 05-005
- Conditions
- Asthma
- Keywords
- asthma, non-invasive inflammometry, exhaled nitric oxide, exhaled breath condensate, paediatric, extrafine HFA-beclomethasone, HFA-fluticasone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- AstraZeneca, Teva Branded
- Study start
- Aug 2005
- Study completion
- Oct 2006
- First posted
- 22 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 78 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extrafine HFA-beclomethasone | Drug | – |
| HFA-fluticasone | Drug | – |
Primary outcome
status of airway inflammation after a 3 months treatment period
alveolar and bronchial exhaled nitric oxide
4 secondary outcomes
inflammatory markers in exhaled breath condensate
lung function parameters
symptoms / symptom free days
adverse effects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte M Robroeks, MD principal investigator
Maastricht University Medical Center
Rijn Jöbsis, MD, PhD study director
Maastricht University Medical Center
Edward Dompeling, MD, PhD study director
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extrafine HFA-beclomethasone and HFA-fluticasone in people with Asthma, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
status of airway inflammation after a 3 months treatment period. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2006.