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Assessment of Intranasal Steroids in Allergic Rhinitis When Used Alone or in Combination With an Oral Antihistamine (Study P03270)

Primary Purpose

Rhinitis, Allergic

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Mometasone furoate
Mometasone furoate
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent form
  • Subjects must be between 18-65 years of age, of either sex and any race
  • Subjects must be diagnosed by the physician to have moderate to severe allergic rhinitis according to ARIA guidelines.
  • Subjects must be mometasone furoate naïve.

Exclusion Criteria:

  • Significant comorbid medical condition.
  • Respiratory tract infection.
  • Any contraindications according to mometasone furoate product monograph.
  • Patients who have received antihistamine treatment within the last 5 days.
  • Patients who have received corticosteroid treatment within the last 30 days.
  • Patients who are likely to require the administration of systemic steroids during the course of this program.
  • Any condition which in the doctor's opinion could interfere with the patient completion of this program.
  • Pregnant or lactating patients.
  • Patients with local infections involving the nasal mucosa.
  • Patients with structural abnormalities or who have undergone nasal surgery or trauma in the past 6 months.
  • Patients with hypersensitivity to mometasone furoate or are allergic to corticosteroids.
  • Patients who are prone to nose bleeding.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Mometasone furoate

    Mometasone furoate plus an oral antihistamine

    Arm Description

    Outcomes

    Primary Outcome Measures

    To assess the mean change in total nasal symptom score from Baseline to the Final Visit of regular intranasal steroid use (mometasone furoate) in allergic rhinitis patients when used alone or in combination with an oral antihistamine.

    Secondary Outcome Measures

    Patient satisfaction with intranasal steroid monotherapy.
    Potential benefit of an oral antihistamine in combination with an intranasal steroid

    Full Information

    First Posted
    October 30, 2008
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00834119
    Brief Title
    Assessment of Intranasal Steroids in Allergic Rhinitis When Used Alone or in Combination With an Oral Antihistamine (Study P03270)
    Official Title
    Assessment of the Effectiveness of Regular Use of Intranasal Steroids in Alleviating Nasal Symptoms in Allergic Rhinitis When Used Alone or in Combination With Oral Antihistamine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2003 (Actual)
    Primary Completion Date
    April 1, 2004 (Actual)
    Study Completion Date
    April 1, 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a Phase 4, non-comparative, open-label, multi-center study. It is designed to determine the effectiveness of regular intranasal steroid use in alleviating allergic rhinitis nasal symptoms, when used alone or in combination with an oral antihistamine. Subjects will receive 200 mcg (2 puffs in each nostril) of mometasone furoate once a day. An oral antihistamine at the discretion of the physician may be added at Day 28 (Visit 2), if patients fail to improve nasal symptoms.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rhinitis, Allergic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mometasone furoate
    Arm Type
    Experimental
    Arm Title
    Mometasone furoate plus an oral antihistamine
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Mometasone furoate
    Other Intervention Name(s)
    Nasonex, SCH 32088
    Intervention Description
    Mometasone furoate 200 mcg (2 puffs in each nostril) once a day for 28 days
    Intervention Type
    Drug
    Intervention Name(s)
    Mometasone furoate
    Other Intervention Name(s)
    Nasonex, SCH 32088
    Intervention Description
    Mometasone furoate 200 mcg (2 puffs in each nostril) once a day plus an oral antihistamine added at Day 28 (Visit 2) at the discretion of the physician
    Primary Outcome Measure Information:
    Title
    To assess the mean change in total nasal symptom score from Baseline to the Final Visit of regular intranasal steroid use (mometasone furoate) in allergic rhinitis patients when used alone or in combination with an oral antihistamine.
    Time Frame
    Day 28 and Day 56
    Secondary Outcome Measure Information:
    Title
    Patient satisfaction with intranasal steroid monotherapy.
    Time Frame
    Day 28
    Title
    Potential benefit of an oral antihistamine in combination with an intranasal steroid
    Time Frame
    Day 56

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent form Subjects must be between 18-65 years of age, of either sex and any race Subjects must be diagnosed by the physician to have moderate to severe allergic rhinitis according to ARIA guidelines. Subjects must be mometasone furoate naïve. Exclusion Criteria: Significant comorbid medical condition. Respiratory tract infection. Any contraindications according to mometasone furoate product monograph. Patients who have received antihistamine treatment within the last 5 days. Patients who have received corticosteroid treatment within the last 30 days. Patients who are likely to require the administration of systemic steroids during the course of this program. Any condition which in the doctor's opinion could interfere with the patient completion of this program. Pregnant or lactating patients. Patients with local infections involving the nasal mucosa. Patients with structural abnormalities or who have undergone nasal surgery or trauma in the past 6 months. Patients with hypersensitivity to mometasone furoate or are allergic to corticosteroids. Patients who are prone to nose bleeding.

    12. IPD Sharing Statement

    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Assessment of Intranasal Steroids in Allergic Rhinitis When Used Alone or in Combination With an Oral Antihistamine (Study P03270)

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