Clinical trial NCT01413958: Effects of Phenylephrine Extended-Release Tablets on Allergy-Related Nasal Congestion (P08498 AM1)
Official title: A Randomized, Placebo-Controlled Trial to Evaluate the Effects of Phenylephrine HCl 30 mg Extended-Release Tablets on Nasal Congestion in Subjects With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Keywords: Nasal Decongestants
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Conditions
Respiratory Tract Diseases
Phenylephrine
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-08-10
Enrollment: 575
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: This study will compare the nasal congestion symptom relief of phenylephrine extended release tablets and placebo in participants with allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Understands study procedures and agrees to participate by giving signed consent form
* Male or female, aged 18 years or older, at the Screening Visit.
* Female participants must demonstrate a negative urine pregnancy test, at Screening (Visit 1) and Visit 2 (prior to randomization) and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the Screening visit and throughout the study and until 2 weeks after the last dose of study drug in the last treatment period. Acceptable methods of birth control are abstinence, or two of the following:

  * hormonal contraceptives (with documented use for at least 30 days prior to Screening )
  * intrauterine device (IUD)
  * diaphragm with spermicide
  * contraceptive sponge
  * condom
  * vasectomy
* Willing to stop use of current decongestant and allergy medications during the trial
* Documented or self-reported history of allergic rhinitis caused by fall pollen within the last 4 years

and documented or self-reported symptoms over at least the last 2 fall allergy seasons

* Documented skin testing (prick with wheal ≥3 mm larger than the diluent or intradermal with wheal ≥7 mm larger than the diluent control) within the last 4 years to fall pollen allergens present and prevalent in his/her geographic region.
* Signs and symptoms of nasal congestion (defined as stuffy or blocked nose) of at least mild severity (sign/symptom clearly present, but minimal awareness; easily tolerated) following the washout period (if applicable). Participant's diary evaluation must document at least mild symptoms for reflective and instantaneous scores on 4 consecutive days prior to randomization.
* Mean seated (after 5 minutes of rest) systolic/diastolic blood pressure ≤ 138/88 mmHg.
* Clinically acceptable physical exam and 12-lead ECG (recorded at 25 mm/s) that is clinically acceptable to the investigator.
* Free of any clinically significant disease that requires a physician's care and/or would interfere with trial evaluations, procedures, or participation.
* Agrees not to take monoamine oxidase inhibitors (MAOIs) from 14 days before trial participation until 14 days after the last dose of study drug.
* Capable of reading English.

Exclusion Criteria:

- Significant medical condition that is a contraindication to the use of phenylephrine, might

interfere with the trial, or requires treatment expected to affect blood pressure

* History or presence of hypertension
* Started allergen immunotherapy within 1 month of enrollment, will start immunotherapy during

the trial, or anticipates immunotherapy dose change during the trial

* Used Xolair (omalizumab) within 4 years prior to trial participation
* Known allergy or intolerance to phenylephrine, loratadine, or desloratadine
* History of rhinitis medicamentosa
* Documented evidence of acute or significant chronic sinusitis
* Clinically significant nasal disorders such as deviated septum and nasal polyposis
* Asthma, with the exception of mild intermittent asthma
* Have used systemic (oral, rectal, injectable), topical (up to 1% topical hydrocortisone

permitted), or nasal corticosteroids in the last 30 days

* Mentally or legally incapacitated, has significant emotional problems at the time of the Screening Visit or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder over the last 5 years. Those who have had situational depression may be enrolled in the study at the discretion of the investigator.
* 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.
* History of immunological disease or cancer within the past 5 years, with the exception of nonmelanoma skin cancer
* Positive drug screen (participants on prescribed medication resulting in a positive drug screen result may still be enrolled at the discretion of the investigator).
* Major surgery or participation in another investigational study within 30 days prior to the Screening Visit.
* Body mass index (BMI) ≥ 40

Primary outcomes:
measure: Mean Change From Baseline in Daily Reflective Nasal Congestion Score
timeFrame: Baseline and Days 1-7
Secondary outcomes:
measure: Mean Change From Baseline in the Morning Reflective Symptom Assessment Score
timeFrame: Baseline and Days 1-7
measure: Mean Change From Baseline in the Evening Reflective Symptom Assessment Score
timeFrame: Baseline and Days 1-7
measure: Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score
timeFrame: Baseline and Days 1-7
measure: Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day
timeFrame: Baseline and Day 1, 2, 3, 4, 5, 6, and 7
measure: Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day
timeFrame: Baseline and Day 1, 2, 3, 4, 5, 6, 7
measure: Time to Maximal Phenylephrine Effect
timeFrame: Baseline up to Day 7
measure: Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score
timeFrame: Baseline and Day 7
measure: Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score
timeFrame: Baseline and Days 1-7
measure: Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period.
timeFrame: Baseline and Day 2, 3, 4, 5, 6, and 7
measure: Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period
timeFrame: Baseline and Day 1, 2, 3, 4, 5, 6, and 7
measure: Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period
timeFrame: Baseline and Day 2, 3, 4, 5, 6, and 7
measure: Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period.
timeFrame: Baseline and Day 1, 2, 3, 4, 5, 6, and 7
measure: Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ)
timeFrame: Up to Day 8
Other outcomes:
Locations:
Study officials:
References:
citation: Meltzer EO, Ratner PH, McGraw T. Phenylephrine hydrochloride modified-release tablets for nasal congestion: a randomized, placebo-controlled trial in allergic rhinitis patients. Ann Allergy Asthma Immunol. 2016 Jan;116(1):66-71. doi: 10.1016/j.anai.2015.10.022. Epub 2015 Nov 7.