Asthma, BronchialNCT00312312
Allergy Towards Grass and Bronchial Inflammation - Related to Immunotherapy and Exhaled Nitrogen Oxide
A study testing Specific immunotherapy in people with Asthma, Bronchial and Allergic Rhinitis, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate the immunomodulatory effect of treatment of allergic rhinitis symptoms with specific immunotherapy by measurement of pulmonary inflammatory markers, and among others, exhaled nitric oxide. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Asthma, Bronchial, Allergic Rhinitis, Hypersensitivity, Immediate
- What is being tested?
- Specific immunotherapy
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2006to Dec 2008
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45 years old
- Skin prick test or RAS test and physical examination conclude that the patient will have a beneficial effect from specific immunotherapy
Who cannot join
- Other diseases except atopic disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen, 2400 NV
Thomas B Knudsen, Medical student, +45 61 70 96 99, thomas@uknet.dk
Thomas B Knudsen, Medical student
About this study
Official title: Does Specific Immunotherapy Possess Immunomodulative Effects at the Bronchial Mucosa Level Among Adults With Atopic Diseases?
The purpose of this study is to evaluate the immunomodulatory effect of treatment of allergic rhinitis symptoms with specific immunotherapy by measurement of pulmonary inflammatory markers, and among others, exhaled nitric oxide.
- Being tested
- Specific immunotherapy
- Keywords
- Asthma, Allergic rhinitis, Atopy, Exhaled nitric oxide, Specific immunotherapy, Atopic diseases
- Medical subject headings
- Asthma, Rhinitis, Allergic, Hypersensitivity, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific immunotherapyBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin prick test
Spirometry
Methacholine provocation of the pulmonary system
Exhaled nitric oxide
Immunoglobulin E (IgE) status
Sputum examination
Condensation of exhaled air
Secondary outcomes (1)
Questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startMar 2006
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, BronchialStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Vibeke Backer, M.D., M.D.Sci, Principal investigator, Lungeforskningsenheden v/Bispebjerg hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312312
- Sponsor's protocol ID
- SITNO
- Status last verified
- Sep 2006
- First submitted
- 5 Apr 2006
- Last updated
- 12 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Specific Immunotherapy Possess Immunomodulative Effects at the Bronchial Mucosa Level Among Adults With Atopic Diseases?
- ClinicalTrials.gov ID
- NCT00312312
- Acronym / sponsor ID
- SITNO
- Keywords
- Asthma, Allergic rhinitis, Atopy, Exhaled nitric oxide, Specific immunotherapy, Atopic diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Dec 2008 (estimated)
- First posted
- 10 Apr 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.
The purpose of this study is to evaluate the immunomodulatory effect of treatment of allergic rhinitis symptoms with specific immunotherapy by measurement of pulmonary inflammatory markers, and among others, exhaled nitric oxide.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-45 years old
- Skin prick test or RAS test and physical examination conclude that the patient will have a beneficial effect from specific immunotherapy
Key exclusion criteria (2 listed)
- Other diseases except atopic disease
- Pregnancy
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 |
|---|---|---|
| Specific immunotherapy | Biological | – |
Primary outcome
Skin prick test
Spirometry
Methacholine provocation of the pulmonary system
Exhaled nitric oxide
Immunoglobulin E (IgE) status
Sputum examination
Condensation of exhaled air
1 secondary outcome
Questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2007.
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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.
Vibeke Backer, M.D., M.D.Sci principal investigator
Lungeforskningsenheden v/Bispebjerg hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific immunotherapy in people with Asthma, Bronchial and Allergic Rhinitis, run by Bispebjerg Hospital at 1 site in Denmark.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Jun 2007. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas B Knudsen, Medical student (+45 61 70 96 99, thomas@uknet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin prick test. The study lists 7 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 12 Jun 2007.