Seasonal Allergic RhinitisPhase 2NCT01260753
Proof of Activity Study of UR-63325 in Allergic Rhinitis Induced by Nasal Challenge
A Phase 2 study testing UR-63325 and Fluticasone propionate nasal spray in people with Seasonal Allergic Rhinitis, run by Palau Pharma S.L.U. at 1 site in Germany.
Trial summary
The purpose of this study is to explore the activity of UR-63325 in a model of allergic rhinitis induced by nasal allergen challenge to known allergic rhinitis patients otherwise healthy. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- UR-63325 and Fluticasone propionate nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2010to Mar 2011
- Phase
- Phase 2
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of written informed consent to participate (prior to any study-related procedures being performed) as shown by a signature on the volunteer consent form and to be able to adhere to the study restrictions and examination schedule
- Subjects with confirmed history of seasonal allergic rhinitis to grass pollen (by direct questioning of presence of positive skin prick test to pollen and History of Symptoms of allergic rhinitis) within the previous two years
- Positive skin prick test to timothy grass pollen (wheal difference with negative control ≥ 3 mm) at screening
- Subjects with positive response to screening nasal challenge with increasing doses of timothy grass pollen (Symptoms worsening with respect to the response to the diluent challenge of ≥4 points in the total nasal symptom score [TNSS]) within one hour after last nasal allergen challenge
- Screening and baseline FEV1 >80% predicted and FEV1/FVC > 70% predicted
Who cannot join
- Symptoms of allergic rhinitis within 2 weeks prior to screening
- Upper respiratory infection or sinusitis within 14 days of screening and also within 14 days of study start in each of the two periods
- Structural nasal abnormalities or nasal polyps on examination, a history of nose bleeding or recent nasal surgery
- History of asthma or asthmatic symptoms or other respiratory disease other than rhinitis within the last 2 years or FEV1<80% of predicted at screening or baseline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind Randomised Placebo and Active Controlled, Proof of Activity Study of UR-63325 in Allergic Rhinitis Induced by Nasal Challenge to Allergic Patients Otherwise Healthy
The purpose of this study is to explore the activity of UR-63325 in a model of allergic rhinitis induced by nasal allergen challenge to known allergic rhinitis patients otherwise healthy.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- UR-63325, Fluticasone propionate nasal spray, Placebo
- 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.
UR-63325Drug
UR-63325
Fluticasone propionate nasal sprayDrug
Fluticasone propionate nasal spray
PlaceboDrug
Placebo to UR 63325 and fluticasone propionate nasal spray
| Study group | Role | What they receive |
|---|---|---|
| UR-63325 | Experimental | Not described Receives: Drug: UR-63325 |
| Fluticasone propionate nasal spray | Active comparator | Not described Receives: Drug: Fluticasone propionate nasal spray |
| 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 and ocular symptoms scores after nasal allergen challenge
Measured: 24 hours
Secondary outcomes (1)
Inflammatory parameters measured from nasal exudate
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2011
- Study completionMar 2011
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palau Pharma S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rainard Fuhr, MD, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260753
- Sponsor's protocol ID
- PPh/00071/10
- Other IDs
- 2010-021858-20
- Status last verified
- Apr 2011
- First submitted
- 13 Dec 2010
- Last updated
- 15 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomised Placebo and Active Controlled, Proof of Activity Study of UR-63325 in Allergic Rhinitis Induced by Nasal Challenge to Allergic Patients Otherwise Healthy
- ClinicalTrials.gov ID
- NCT01260753
- Acronym / sponsor ID
- PPh/00071/10
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Palau Pharma S.L.U.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 Dec 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.
The purpose of this study is to explore the activity of UR-63325 in a model of allergic rhinitis induced by nasal allergen challenge to known allergic rhinitis patients otherwise healthy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UR-63325 | Experimental | Drug: UR-63325 |
| Fluticasone propionate nasal spray | Active comparator | Drug: Fluticasone propionate nasal spray |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provision of written informed consent to participate (prior to any study-related procedures being performed) as shown by a signature on the volunteer consent form and to be able to adhere to the study restrictions and examination schedule
- Subjects with confirmed history of seasonal allergic rhinitis to grass pollen (by direct questioning of presence of positive skin prick test to pollen and History of Symptoms of allergic rhinitis) within the previous two years
- Positive skin prick test to timothy grass pollen (wheal difference with negative control ≥ 3 mm) at screening
- Subjects with positive response to screening nasal challenge with increasing doses of timothy grass pollen (Symptoms worsening with respect to the response to the diluent challenge of ≥4 points in the total nasal symptom score [TNSS]) within one hour after last nasal allergen challenge
- Screening and baseline FEV1 >80% predicted and FEV1/FVC > 70% predicted
Key exclusion criteria (4 listed)
- Symptoms of allergic rhinitis within 2 weeks prior to screening
- Upper respiratory infection or sinusitis within 14 days of screening and also within 14 days of study start in each of the two periods
- Structural nasal abnormalities or nasal polyps on examination, a history of nose bleeding or recent nasal surgery
- History of asthma or asthmatic symptoms or other respiratory disease other than rhinitis within the last 2 years or FEV1<80% of predicted at screening or baseline
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 |
|---|---|---|
| UR-63325UR-63325 | Drug | UR-63325 |
| Fluticasone propionate nasal sprayFluticasone propionate nasal spray | Drug | Fluticasone propionate nasal spray |
| PlaceboPlacebo to UR 63325 and fluticasone propionate nasal spray | Drug | Placebo |
Primary outcome
Nasal and ocular symptoms scores after nasal allergen challenge
Time frame: 24 hours
1 secondary outcome
Inflammatory parameters measured from nasal exudate
Time frame: 24 hours
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 Apr 2011.
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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.
Rainard Fuhr, MD principal investigator
Parexel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UR-63325 and Fluticasone propionate nasal spray in people with Seasonal Allergic Rhinitis, run by Palau Pharma S.L.U. at 1 site in Germany.
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 5 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 Apr 2011. 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 and ocular symptoms scores after nasal allergen challenge (time frame: 24 hours). 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 Apr 2011; AzTrials last refreshed its copy on 8 Nov 2026.