Seasonal Allergic RhinitisPhase 1NCT00483353
Effect of a Nasal Bolus Allergen Challenge on Inflammatory Markers
A Phase 1 study testing Intra-nasal allergen challenge with Phleum pratense., Collection of nasal effluent using filter paper. and Measurement of nasal congestion using acoustic rhinometry. in people with Seasonal Allergic Rhinitis, run by Pfizer at 1 site in United Kingdom.
Trial summary
The current study will investigate nasal inflammatory markers obtained by filter paper collection techniques, in subjects with allergic rhinitis, determining the most appropriate time points and handling conditions, prior to running a larger study with subjects with allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Intra-nasal allergen challenge with Phleum pratense., Collection of nasal effluent using filter paper. and Measurement of nasal congestion using acoustic rhinometry.
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2007to not given
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects with allergic rhinitis, that have a positive skin prick response to Phleum pratense.
Who cannot join
- Subjects with a history of asthma. Current smokers, or recent ex-smokers and subjects that have had a respiratory tract infection in the previous 4 weeks.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Pfizer Investigational Site
London, England, SW3 6HP
About this study
Official title: A Pilot Study to Explore the Effect of a Nasal Bolus Allergen Challenge on Inflammatory Markers in Subjects With Seasonal Allergic Rhinitis
The current study will investigate nasal inflammatory markers obtained by filter paper collection techniques, in subjects with allergic rhinitis, determining the most appropriate time points and handling conditions, prior to running a larger study with subjects with allergic rhinitis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Intra-nasal allergen challenge with Phleum pratense., Collection of nasal effluent using filter paper., Measurement of nasal congestion using acoustic rhinometry.
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-nasal allergen challenge with Phleum pratense.Procedure or surgery
Collection of nasal effluent using filter paper.Procedure or surgery
Measurement of nasal congestion using acoustic rhinometry.Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Post allergen challenge nasal inflammatory markers at 1, 5, 15, 30, 45 min, 1, 2, 3, 4, 5, 6, 7, 8 hours post allergen challenge.
Secondary outcomes (1)
Post allergen challenge effects on acoustic rhinometry and symptoms at 16, 31, 45 min, 1, 2, 3, 4, 5, 6, 7, 8 hours post allergen challenge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study startJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483353
- Sponsor's protocol ID
- A9011058
- Status last verified
- Jun 2008
- First submitted
- 5 Jun 2007
- Last updated
- 17 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Explore the Effect of a Nasal Bolus Allergen Challenge on Inflammatory Markers in Subjects With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00483353
- Acronym / sponsor ID
- A9011058
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- First posted
- 7 Jun 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.
The current study will investigate nasal inflammatory markers obtained by filter paper collection techniques, in subjects with allergic rhinitis, determining the most appropriate time points and handling conditions, prior to running a larger study with subjects with allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female subjects with allergic rhinitis, that have a positive skin prick response to Phleum pratense.
Key exclusion criteria (1 listed)
- Subjects with a history of asthma. Current smokers, or recent ex-smokers and subjects that have had a respiratory tract infection in the previous 4 weeks.
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 |
|---|---|---|
| Intra-nasal allergen challenge with Phleum pratense. | Procedure or surgery | – |
| Collection of nasal effluent using filter paper. | Procedure or surgery | – |
| Measurement of nasal congestion using acoustic rhinometry. | Procedure or surgery | – |
Primary outcome
Post allergen challenge nasal inflammatory markers at 1, 5, 15, 30, 45 min, 1, 2, 3, 4, 5, 6, 7, 8 hours post allergen challenge.
1 secondary outcome
Post allergen challenge effects on acoustic rhinometry and symptoms at 16, 31, 45 min, 1, 2, 3, 4, 5, 6, 7, 8 hours post allergen challenge.
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 17 Jun 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intra-nasal allergen challenge with Phleum pratense., Collection of nasal effluent using filter paper. and Measurement of nasal congestion using acoustic rhinometry. in people with Seasonal Allergic Rhinitis, run by Pfizer at 1 site in United Kingdom.
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 1 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 17 Jun 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 United Kingdom. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Post allergen challenge nasal inflammatory markers at 1, 5, 15, 30, 45 min, 1, 2, 3, 4, 5, 6, 7, 8 hours post allergen challenge.. 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 17 Jun 2008.