Allergic RhinitisPhase 1NCT01064726
A Study To Explore The Effect On Inflammatory Markers After Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis And The Effect Of A Single Dose Of Ibuprofen Or Fluticasone Propionate On The Allergen Response.
A Phase 1 study testing Ibuprofen and Fluticasone propionate in people with Allergic Rhinitis, run by Pfizer at 1 site in United States.
Trial summary
After a nasal allergen challenge it should be possible to measure markers of inflammation that may be useful to assess the properties of future drugs. If these markers are reproducible and impacted by the study drugs they could be useful for future drug development. Read more about this study
- Who is it for?
- Ages 19 to 55 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Ibuprofen and Fluticasone propionate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Apr 2010
- 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 19 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects with seasonal allergic rhinitis (out of season).
- Sensitive to ragweed skin prick test and screening nasal allergen challenge.
Who cannot join
- Subjects with significant concomitant diseases.
- Subjects with symptoms of allergic rhinitis in 2 weeks prior to screening.
- Female subjects that are pregnant or nursing. Subjects with hypersensitivity to study drugs or allergen challenge.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind (3rd Party Open), 3-Way Crossover Study To Explore The Reproducibility Of Inflammatory Markers After Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis (Out Of Season) And The Effect Of A Single Dose Of Ibuprofen Or Fluticasone Propionate On The Allergen Response.
After a nasal allergen challenge it should be possible to measure markers of inflammation that may be useful to assess the properties of future drugs. If these markers are reproducible and impacted by the study drugs they could be useful for future drug development.
- Conditions
- Allergic Rhinitis
- Being tested
- Ibuprofen, Fluticasone propionate, Placebo
- Keywords
- Allergic Rhinitis Nasal Allergen Challenge Inflammatory Markers
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
800 mg oral
Fluticasone propionateDrug
200 mcg intra-nasal
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | Not described Receives: Drug: Ibuprofen |
| Fluticasone propionate | Experimental | Not described Receives: Drug: Fluticasone propionate |
| 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.
Nasal inflammatory markers
Measured: 8h 45 min post dose
Acoustic rhinometry
Measured: 8h 45 min post dose
Nasal symptom scores
Measured: 8h 45 min post dose
Secondary outcomes (1)
Spirometry
Measured: 8h 45 min post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionApr 2010
- Study completionApr 2010
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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
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
- NCT01064726
- Sponsor's protocol ID
- A9011065
- Status last verified
- Jun 2010
- First submitted
- 21 Sep 2009
- Last updated
- 2 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind (3rd Party Open), 3-Way Crossover Study To Explore The Reproducibility Of Inflammatory Markers After Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis (Out Of Season) And The Effect Of A Single Dose Of Ibuprofen Or Fluticasone Propionate On The Allergen Response.
- ClinicalTrials.gov ID
- NCT01064726
- Acronym / sponsor ID
- A9011065
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis Nasal Allergen Challenge Inflammatory Markers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 8 Feb 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.
After a nasal allergen challenge it should be possible to measure markers of inflammation that may be useful to assess the properties of future drugs. If these markers are reproducible and impacted by the study drugs they could be useful for future drug development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: Ibuprofen |
| Fluticasone propionate | Experimental | Drug: Fluticasone propionate |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female subjects with seasonal allergic rhinitis (out of season).
- Sensitive to ragweed skin prick test and screening nasal allergen challenge.
Key exclusion criteria (3 listed)
- Subjects with significant concomitant diseases.
- Subjects with symptoms of allergic rhinitis in 2 weeks prior to screening.
- Female subjects that are pregnant or nursing. Subjects with hypersensitivity to study drugs or allergen challenge.
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 |
|---|---|---|
| Ibuprofen800 mg oral | Drug | Ibuprofen |
| Fluticasone propionate200 mcg intra-nasal | Drug | Fluticasone propionate |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Nasal inflammatory markers
Time frame: 8h 45 min post dose
Acoustic rhinometry
Time frame: 8h 45 min post dose
Nasal symptom scores
Time frame: 8h 45 min post dose
1 secondary outcome
Spirometry
Time frame: 8h 45 min post dose
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 2 Jun 2010.
- 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 Ibuprofen and Fluticasone propionate in people with Allergic Rhinitis, run by Pfizer at 1 site in United States.
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 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 2 Jun 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 United States. 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 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?
Nasal inflammatory markers (time frame: 8h 45 min post dose). The study lists 3 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 2 Jun 2010.