Allergic RhinitisNCT00513487
Effects of Multiple Nasal Exposures to House Dust Mite Allergen on Nasal and Body Inflammation and Airway Sensitivity
A study testing Dust mite extract, Fluticasone, Methacholine in people with Allergic Rhinitis, run by Novartis at 1 site in Australia.
Trial summary
This study will evaluate whether multiple nasal antigen challenges with dust mite allergen produces increases in nasal symptoms and local allergic inflammatory cells in the nose and the blood. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Dust mite extract, Fluticasone, Methacholine
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2007to Nov 2007
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy non-smoking subjects with a history of allergic rhinitis consistent with dust mite allergy showing
- A positive skin prick test to dust mite at or within the 12 months before study start
- Demonstrate symptomatic worsening after graded nasal allergen challenge
Who cannot join
- Subjects found to be very sensitive to house dust mites (if the skin prick test produces a wheal of mean with a diameter greater than 11 mm).
- Presence of any respiratory disease other than a history of mild stable asthma not requiring regular treatment.
- Any known contraindications for methacholine challenge testing
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Effects of Multiple Nasal Antigen Challenges With Dust Mite Allergen on Local and Systemic Allergic Inflammation and Bronchoreactivity in Subjects With Allergic Rhinitis Sensitive to House Dust Mite - a Feasibility and Site Evaluation Study
This study will evaluate whether multiple nasal antigen challenges with dust mite allergen produces increases in nasal symptoms and local allergic inflammatory cells in the nose and the blood.
- Conditions
- Allergic Rhinitis
- Being tested
- Dust mite extract, Fluticasone, Methacholine
- Keywords
- Allergic Rhinitis, dust mites, IgE, IL-13, nasal, inflammation
- Medical subject headings
- Rhinitis, Allergic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dust mite extract, Fluticasone, MethacholineDrug
Dust mite extract, Fluticasone, Methacholine
What is being measured
The primary outcome is the main question the study is designed to answer.
Total nasal symptom score recorded at baseline, and at pre-challenge,15 mins, 30 mins,and at 1,2,3,4,8 hours
Measured: throughout the study
Secondary outcomes (1)
Peak nasal inspiratory flow at time points of total nasal symptom score. Mechanistic markers during challenge days. Exhaled nitric oxide,forced expiratory vol in 1 second & airway resistance at baseline, first & last day
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startJul 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Investigative site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513487
- Sponsor's protocol ID
- CPJMR0052107
- Status last verified
- Jul 2008
- First submitted
- 6 Aug 2007
- Last updated
- 15 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Multiple Nasal Antigen Challenges With Dust Mite Allergen on Local and Systemic Allergic Inflammation and Bronchoreactivity in Subjects With Allergic Rhinitis Sensitive to House Dust Mite - a Feasibility and Site Evaluation Study
- ClinicalTrials.gov ID
- NCT00513487
- Acronym / sponsor ID
- CPJMR0052107
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis, dust mites, IgE, IL-13, nasal, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Study completion
- Nov 2007 (actual)
- First posted
- 8 Aug 2007 (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.
This study will evaluate whether multiple nasal antigen challenges with dust mite allergen produces increases in nasal symptoms and local allergic inflammatory cells in the nose and the blood.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy non-smoking subjects with a history of allergic rhinitis consistent with dust mite allergy showing
- A positive skin prick test to dust mite at or within the 12 months before study start
- Demonstrate symptomatic worsening after graded nasal allergen challenge
Key exclusion criteria (4 listed)
- Subjects found to be very sensitive to house dust mites (if the skin prick test produces a wheal of mean with a diameter greater than 11 mm).
- Presence of any respiratory disease other than a history of mild stable asthma not requiring regular treatment.
- Any known contraindications for methacholine challenge testing
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| Dust mite extract, Fluticasone, MethacholineDust mite extract, Fluticasone, Methacholine | Drug | – |
Primary outcome
Total nasal symptom score recorded at baseline, and at pre-challenge,15 mins, 30 mins,and at 1,2,3,4,8 hours
Time frame: throughout the study
1 secondary outcome
Peak nasal inspiratory flow at time points of total nasal symptom score. Mechanistic markers during challenge days. Exhaled nitric oxide,forced expiratory vol in 1 second & airway resistance at baseline, first & last day
Time frame: throughout the study
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 15 Jul 2008.
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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.
Novartis principal investigator
Investigative site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dust mite extract, Fluticasone, Methacholine in people with Allergic Rhinitis, run by Novartis at 1 site in Australia.
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 3 inclusion and 4 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 15 Jul 2008. 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 Australia. 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?
Total nasal symptom score recorded at baseline, and at pre-challenge,15 mins, 30 mins,and at 1,2,3,4,8 hours (time frame: throughout the study). 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 15 Jul 2008.