Clinical trial NCT01330017: Effects of Phenylephrine on Nasal Congestion in Participants With Seasonal Allergic Rhinitis (P08156 AM2)(Completed)
Official title: A Randomized, Dose-ranging, Placebo-controlled Trial to Evaluate the Effects of Phenylephrine HCl Immediate Release Tablets on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinitis
Seasonal Rhinitis
Keywords: Seasonal allergies
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-04-06
Enrollment: 539
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial will evaluate the nasal congestion symptom relief of the approved 10 mg phenylephrine (PE) dose and the higher 20 mg, 30 mg, and 40 mg PE doses compared with placebo in participants with histories of seasonal allergic rhinitis, using loratadine as background medication.


Eligibility criteria: Inclusion criteria:

* Female participants of reproductive potential must have a negative pregnancy test and agree to use acceptable methods of birth control throughout the study.
* Participant is willing to stop use of current decongestant and allergy medications during the trial.
* Participant has a documented or self-reported history of seasonal allergy.
* Participant has documented positive skin testing to spring pollen allergens.
* Participant has nasal congestion of at least moderate severity.
* Participant has mean seated (after 5 minutes of rest) systolic/diastolic blood pressure ≤138/88 mmHg.
* Participant has clinically acceptable physical exam and 12-lead electrocardiogram (ECG).
* Participant is without clinically significant disease.
* Participant must agree not to take monoamine oxidase inhibitor (MAOI) from 14 days before trial participation until 14 days after the end of the trial.
* Participant must sign an informed consent form

Exclusion criteria:

* Participants must not have any significant medical condition that is a contraindication to the use of phenylephrine HCl or loratadine, such as thyroid disease, uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, or prostatic hypertrophy.
* Participants with a history or presence of hypertension.
* Participants who have started allergen immunotherapy within a month preceding enrollment or starting allergen immunotherapy or anticipating immunotherapy dose change during the trial. Xolair (omalizumab) may not be used within 4 years prior to trial participation.
* Participants who have a known allergy or intolerance to phenylephrine HCl, any other decongestant, loratadine, desloratadine, or any other antihistamine.
* Participants with persistent asthma, rhinitis medicamentosa, or acute or chronic sinusitis, or a history of significant sinusitis within one month of enrollment.
* Participant with a history of intermittent asthma may be considered for enrollment provided they have no asthma symptoms at the time of enrollment and use only a short acting beta2-agonist less than twice weekly.
* Participants who have used systemic (oral, rectal, injectable), topical, or nasal corticosteroids in the last 30 days (up to 1% topical hydrocortisone is permitted).
* Participants using a leukotriene receptor antagonist for maintenance treatment of asthma.
* Participant with a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
* Participant with a history of immunological disease or malignancy within the past 5 years, with the exception of non-melanoma skin cancer.
* Participant with positive drug screen (participants on prescribed medication resulting in a positive drug screen result may still be enrolled at the discretion of the investigator).
* Participant has had major surgery or participated in another investigational study within 4 weeks prior to the Screening Visit.
* Participants taking any herbal supplements during trial conduct.

Primary outcomes:
measure: Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score
timeFrame: Baseline, Day 7
Secondary outcomes:
measure: Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period
timeFrame: Baseline and Days 2, 3, 4, 5, 6, and 7
measure: Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period
timeFrame: Baseline and Days 1, 2, 3, 4, 5, 6, and 7
measure: Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period
timeFrame: Baseline and Day 2, 3, 4, 5, 6, and 7
measure: Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period
timeFrame: Baseline and Days 1, 2, 3, 4, 5, 6, and 7
measure: Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period
timeFrame: Baseline and Days 1, 2, 3, 4, 5, 6, and 7
measure: Time to Maximal Effect
timeFrame: Baseline up to Day 7
measure: Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7
timeFrame: Baseline, Day 7
Other outcomes:
Locations:
Study officials:
References:
citation: Meltzer EO, Ratner PH, McGraw T. Oral Phenylephrine HCl for Nasal Congestion in Seasonal Allergic Rhinitis: A Randomized, Open-label, Placebo-controlled Study. J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):702-8. doi: 10.1016/j.jaip.2015.05.007. Epub 2015 Jul 2.