A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge

Pfizer

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis

Treatments: Drug: Allegra-D; Drug: Allegra; Drug: PF-03654746; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00562120

A8801003

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

21 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Allegra

Active Comparator group

Treatment:

Drug: Allegra

Allegra-D

Active Comparator group

Treatment:

Drug: Allegra-D

PF-03654746

Experimental group

Treatment:

Drug: PF-03654746