Allergic RhinitisPhase 2NCT01033396
The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis
A Phase 2 study testing PF-03654764, Allegra and Allegra-D in people with Allergic Rhinitis, run by Pfizer at 1 site in Canada.
Trial summary
PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be exposed to pollen and their symptoms observed. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- PF-03654764, Allegra and Allegra-D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to May 2010
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects 18-60 years allergic to ragweed pollen.
- Subjects with appropriate symptom scores following exposure to ragweed in the environmental exposure unit.
Who cannot join
- Subjects with significant diseases other than allergic rhinitis that may interfere with the safety or efficacy of PF-03654764.
- Subjects with significant symptoms of allergic rhinitis within the 2 weeks prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Four Way Crossover Study To Determine The Effects Of PF-03654764 +/- Allegra (Fexofenadine) On Symptoms Of Allergic Rhinitis In Subjects Exposed To Ragweed Pollen In An Environmental Exposure Unit.
PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be exposed to pollen and their symptoms observed.
- Conditions
- Allergic Rhinitis
- Being tested
- PF-03654764, Allegra, Allegra-D, Placebo
- Keywords
- Allergic rhinitis Environmental exposure unit
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-03654764Drug
PF-03654764 single dose 5 mg
AllegraDrug
Fexofenadine single dose 60 mg
PF-03654764Drug
PF-03654764 single dose 5 mg
Allegra-DDrug
Fexofenadine 60 mg combined with pseudoephedrine 120 mg single dose
PlaceboDrug
Placebo single dose
| Study group | Role | What they receive |
|---|---|---|
| PF-03654764 + Allegra | Experimental | Not described Receives: Drug: PF-03654764; Drug: Allegra |
| PF-03654764 | Experimental | Not described Receives: Drug: PF-03654764 |
| Allegra-D | Active comparator | Not described Receives: Drug: Allegra-D |
| 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.
Congestion scores
Measured: 6 hours
Other allergic rhinitis symptoms
Measured: 6 hours
Secondary outcomes (3)
Pharmacokinetics
Measured: 6 hours
Blood pressure/pulse rate
Measured: 6 hours
Adverse event reporting
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 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
- NCT01033396
- Sponsor's protocol ID
- B0711005
- Status last verified
- Aug 2010
- First submitted
- 14 Dec 2009
- Last updated
- 17 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
North ML, Walker TJ, Steacy LM, Hobsbawn BG, Allan RJ, Hackman F, Sun X, Day AG, Ellis AK. Add-on histamine receptor-3 antagonist for allergic rhinitis: a double blind randomized crossover trial using the environmental exposure unit. Allergy Asthma Clin Immunol. 2014 Jul 3;10(1):33. doi: 10.1186/1710-1492-10-33. eCollection 2014.
PubMed 25024716
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Four Way Crossover Study To Determine The Effects Of PF-03654764 +/- Allegra (Fexofenadine) On Symptoms Of Allergic Rhinitis In Subjects Exposed To Ragweed Pollen In An Environmental Exposure Unit.
- ClinicalTrials.gov ID
- NCT01033396
- Acronym / sponsor ID
- B0711005
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis Environmental exposure unit
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 16 Dec 2009 (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.
PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be exposed to pollen and their symptoms observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PF-03654764 + Allegra | Experimental | Drug: PF-03654764, Drug: Allegra |
| PF-03654764 | Experimental | Drug: PF-03654764 |
| Allegra-D | Active comparator | Drug: Allegra-D |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female subjects 18-60 years allergic to ragweed pollen.
- Subjects with appropriate symptom scores following exposure to ragweed in the environmental exposure unit.
Key exclusion criteria (2 listed)
- Subjects with significant diseases other than allergic rhinitis that may interfere with the safety or efficacy of PF-03654764.
- Subjects with significant symptoms of allergic rhinitis within the 2 weeks prior to screening.
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 |
|---|---|---|
| PF-03654764PF-03654764 single dose 5 mg | Drug | PF-03654764 + Allegra |
| AllegraFexofenadine single dose 60 mg | Drug | PF-03654764 + Allegra |
| PF-03654764PF-03654764 single dose 5 mg | Drug | PF-03654764 |
| Allegra-DFexofenadine 60 mg combined with pseudoephedrine 120 mg single dose | Drug | Allegra-D |
| PlaceboPlacebo single dose | Drug | Placebo |
Primary outcome
Congestion scores
Time frame: 6 hours
Other allergic rhinitis symptoms
Time frame: 6 hours
3 secondary outcomes
Pharmacokinetics
Time frame: 6 hours
Blood pressure/pulse rate
Time frame: 6 hours
Adverse event reporting
Time frame: 2 months
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 Aug 2010.
- Derived from this study: PubMed 25024716North ML, Walker TJ, Steacy LM, Hobsbawn BG, Allan RJ, Hackman F, Sun X, Day AG, Ellis AK. Add-on histamine receptor-3 antagonist for allergic rhinitis: a double blind randomized crossover trial using the environmental exposure unit. Allergy Asthma Clin Immunol. 2014 Jul 3;10(1):33. doi: 10.1186/1710-1492-10-33. eCollection 2014.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Allergic Rhinitis
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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 2 study testing PF-03654764, Allegra and Allegra-D in people with Allergic Rhinitis, run by Pfizer at 1 site in Canada.
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: finished, as of the sponsor's last update on 17 Aug 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 Canada. 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?
Congestion scores (time frame: 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01033396, which also lists 1 linked publication.
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 Aug 2010.