Clinical trial NCT00562120: A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge
Official title: A Randomized, Double Blind, Double Dummy, Placebo Controlled, Four Way Crossover Study To Determine The Effects Of An H3 Receptor Antagonist (PF-03654746) On Congestion Following A Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-21
Enrollment: 21
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Minimum Cross-Sectional Area (Amin) Proportion Measured Using Acoustic Rhinometry
timeFrame: 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period
measure: Nasal Volume Proportion Measured Using Acoustic Rhinometry
timeFrame: 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period
Secondary outcomes:
measure: Minimum Cross-Sectional Area (Amin) Maximum Fall Measured Using Acoustic Rhinometry
timeFrame: 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period
measure: Nasal Volume Maximum Fall Measured Using Acoustic Rhinometry
timeFrame: 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period
measure: Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea
timeFrame: 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Pre-allergen challenge); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose (Post-allergen challenge); 3 hrs 40 min post dose (Post-oxymetazoline) on Day 1 of each intervention period
measure: Nasal Symptom Scores: Sneezing
timeFrame: 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period
Other outcomes:
measure: Serum PF-03654746 Concentration
timeFrame: 1 hr 30 min post dose on Day 1 of each intervention period
Locations:
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: