AsthmaPhase 3NCT01113489
Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone
A Phase 3 study testing beclomethasone dipropionate in people with Asthma and Allergic Rhinitis, run by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy at 1 site in Italy.
Trial summary
Although it is well known that the presence of uncontrolled inflammation in upper airways may compromise the control of asthma and may favor the progression of asthma toward more severe grades of disease, few studies addressed whether therapies aimed to control both upper and lower airway inflammation may be more… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Asthma, Allergic Rhinitis
- What is being tested?
- beclomethasone dipropionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2010to Jul 2010
- Phase
- Phase 3
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with intermittent asthma and allergic rhinitis
Who cannot join
- children with acute respiratory symptoms in the last 4 weeks
- children with nasal polyposis or bronchial or respiratory tract infections
- children with a severe exacerbation of asthma resulting in hospitalization during the last month
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Immunopathology and Pharmacology of the Respiratory System Institute of Biomedicine and Molecular Immunology (IBIM) Italian National Research (CNR)
Palermo, 90146
About this study
Although it is well known that the presence of uncontrolled inflammation in upper airways may compromise the control of asthma and may favor the progression of asthma toward more severe grades of disease, few studies addressed whether therapies aimed to control both upper and lower airway inflammation may be more effective in controlling asthma. Markers of oxidative stress and of inflammation such as Nitrotyrosine and IL-5 are increased in the airways of children with atopic asthma and correlated with the levels of oral and nasal FeNO, and with the grade of atopy. We hypothesize that the treatment with Beclometasone nebulized with a facial mask (for treating both upper and lower airways) will be able to reduce the production of oxidants as well as of IL5 in both districts thus promoting clinical and functional improvements in mild intermittent asthmatic children. The results provided by this study will contribute to further clarify the relationship between nasal and bronchial inflammation.
- Conditions
- Asthma, Allergic Rhinitis
- Being tested
- beclomethasone dipropionate, placebo
- Medical subject headings
- Asthma, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beclomethasone dipropionateDrug
400 mcg/1 ml b.i.d.
placeboDrug
1 ml b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| beclomethasone dipropionate suspension for nebulization | Experimental | Not described Receives: Drug: beclomethasone dipropionate |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of oral and nasal fractional exhaled nitric oxide (FeNO)
Measured: Baseline, 4 weeks
Secondary outcomes (7)
Change in peak expiratory flow (PEF)
Measured: Baseline, 4 weeks
change in visual analogue scale score for symptoms of rhinitis
Measured: Baseline, 4 weeks
change in obstructive sleep apnea syndrome score
Measured: Baseline, 4 weeks
change in forced vital capacity (FVC)
Measured: Baseline, 4 weeks
change in symptom scores of wheezing
Measured: Baseline, 4 weeks
change in forced expiratory volume in 1 second (FEV1)
Measured: Baseline, 4 weeks
change in level of IL-5 in exhaled breath condensate
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2010
- Study completionJul 2010
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113489
- Sponsor's protocol ID
- 0002565
- Status last verified
- May 2010
- First submitted
- 15 Apr 2010
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone
- ClinicalTrials.gov ID
- NCT01113489
- Acronym / sponsor ID
- 0002565
- Conditions
- Asthma, Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, ItalyOther government
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 30 Apr 2010 (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.
Although it is well known that the presence of uncontrolled inflammation in upper airways may compromise the control of asthma and may favor the progression of asthma toward more severe grades of disease, few studies addressed whether therapies aimed to control both upper and lower airway inflammation may be more effective in controlling asthma. Markers of oxidative stress and of inflammation such as Nitrotyrosine and IL-5 are increased in the airways of children with atopic asthma and correlated with the levels of oral and nasal FeNO, and with the grade of atopy. We hypothesize that the treatment with Beclometasone nebulized with a facial mask (for treating both upper and lower airways) will be able to reduce the production of oxidants as well as of IL5 in both districts thus promoting clinical and functional improvements in mild intermittent asthmatic children. The results provided by this study will contribute to further clarify the relationship between nasal and bronchial inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| beclomethasone dipropionate suspension for nebulization | Experimental | Drug: beclomethasone dipropionate |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children with intermittent asthma and allergic rhinitis
Key exclusion criteria (3 listed)
- children with acute respiratory symptoms in the last 4 weeks
- children with nasal polyposis or bronchial or respiratory tract infections
- children with a severe exacerbation of asthma resulting in hospitalization during the last month
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 |
|---|---|---|
| beclomethasone dipropionate400 mcg/1 ml b.i.d. | Drug | beclomethasone dipropionate suspension for nebulization |
| placebo1 ml b.i.d. | Drug | placebo |
Primary outcome
Change in level of oral and nasal fractional exhaled nitric oxide (FeNO)
Time frame: Baseline, 4 weeks
7 secondary outcomes
Change in peak expiratory flow (PEF)
Time frame: Baseline, 4 weeks
change in visual analogue scale score for symptoms of rhinitis
Time frame: Baseline, 4 weeks
change in obstructive sleep apnea syndrome score
Time frame: Baseline, 4 weeks
change in forced vital capacity (FVC)
Time frame: Baseline, 4 weeks
change in symptom scores of wheezing
Time frame: Baseline, 4 weeks
change in forced expiratory volume in 1 second (FEV1)
Time frame: Baseline, 4 weeks
change in level of IL-5 in exhaled breath condensate
Time frame: Baseline, 4 weeks
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 27 Jul 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing beclomethasone dipropionate in people with Asthma and Allergic Rhinitis, run by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy at 1 site in Italy.
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 1 inclusion and 3 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 27 Jul 2010. 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 Italy. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in level of oral and nasal fractional exhaled nitric oxide (FeNO) (time frame: Baseline, 4 weeks). 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 27 Jul 2010.