Phase 2
N=21
A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge
Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00562120 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Minimum Cross-Sectional Area (Amin) Proportion Measured Using Acoustic Rhinometry — 0.760; 0.742; 0.717; 0.795 ratio — p=0.302
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Allegra (Drug); Allegra-D (Drug); PF-03654746 (Drug)
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minimum Cross-Sectional Area (Amin) Proportion Measured Using Acoustic Rhinometry |
0.760; 0.742; 0.717; 0.795 | 0.302 |
| PRIMARY Nasal Volume Proportion Measured Using Acoustic Rhinometry |
0.800; 0.796; 0.744; 0.856 | 0.269 |
| SECONDARY Minimum Cross-Sectional Area (Amin) Maximum Fall Measured Using Acoustic Rhinometry |
0.155; 0.157; 0.204; 0.190 | 0.130 |
| SECONDARY Nasal Volume Maximum Fall Measured Using Acoustic Rhinometry |
3.132; 3.244; 4.443; 3.275 | 0.357 |
| SECONDARY Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea |
0.2; 0.4; 0.4; 0.4; 1.5; 1.8 | 0.011 sig |
| SECONDARY Nasal Symptom Scores: Sneezing |
0.0; 0.1; 0.1; 0.1; 0.7; 0.6 | 0.000 sig |
Summary
An H3 receptor antagonist should reduce the congestion associated with allergic rhinitis. A nasal allergen challenge will be given to patients to induce rhinitis symptoms and acoustic rhinometry will be used to measure the congestion.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects 19-55 years with allergic rhinitis requiring treatment within the previous 2 years.
- Subjects that respond to a ragweed nasal allergen challenge at screening.
Exclusion Criteria
- History of asthma or FEV1 < 80% predicted.
- Significant concomitant disease or medications.
- Symptoms of allergic rhinitis within 2 weeks prior to screening.
Data sourced from ClinicalTrials.gov (NCT00562120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.