Effects of Phenylephrine on Nasal Congestion in Participants With Seasonal Allergic Rhinitis (P08156 AM2)(Completed)

NCT01330017 | Completed Phase 2 Results

• 3 other identifiers: 18123CL2010-06P08156
• Study Type: interventional
• Target: 539
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rhinitis; Seasonal Rhinitis

Keywords

Seasonal allergies

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score

  The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. Participants rated congestion on a 4-point scale of severity from 0 (best) to 3 (worst), with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. Baseline was defined as the average of the daily scores over the 4 consecutive 24-hour periods before randomization.

  Baseline, Day 7

Secondary Outcomes (7)

• Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period

  Baseline and Days 2, 3, 4, 5, 6, and 7

• Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period

  Baseline and Days 1, 2, 3, 4, 5, 6, and 7

• Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period

  Baseline and Day 2, 3, 4, 5, 6, and 7

• Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period

  Baseline and Days 1, 2, 3, 4, 5, 6, and 7

• Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period

  Baseline and Days 1, 2, 3, 4, 5, 6, and 7

Study Arms (5)

PE 10 mg

EXPERIMENTAL

Drug: Phenylephrine HCl; Drug: Placebo; Drug: Loratadine

PE 20 mg

EXPERIMENTAL

Drug: Phenylephrine HCl; Drug: Placebo; Drug: Loratadine

PE 30 mg

EXPERIMENTAL

Drug: Phenylephrine HCl; Drug: Placebo; Drug: Loratadine

PE 40 mg

EXPERIMENTAL

Drug: Phenylephrine HCl; Drug: Placebo; Drug: Loratadine

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Drug: Loratadine

Interventions

Phenylephrine HCl DRUG

10-mg immediate-release tablets, orally, up to 4 tablets per dose every 4 hours, for 7 days

Also known as: SCH 002063

PE 10 mg; PE 20 mg; PE 30 mg; PE 40 mg

Placebo DRUG

Placebo tablets, orally, up to five tablets per dose every 4 hours, for 7 days

PE 10 mg; PE 20 mg; PE 30 mg; PE 40 mg; Placebo

Loratadine DRUG

10-mg tablets, orally, once per day at a dose not to exceed 10 mg in a 24-hour period.

Also known as: Claritin®

PE 10 mg; PE 20 mg; PE 30 mg; PE 40 mg; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Related Publications (1)

• 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.

  PMID: 26143019 DERIVED

MeSH Terms

Conditions

Rhinitis; Rhinitis, Allergic, Seasonal

Interventions

Oxymetazoline; Loratadine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Rhinitis, Allergic; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Polycyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 6, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 11, 2015
• Results First Posted: November 7, 2012

Record last verified: 2015-02