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A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512)

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT00783224
Collaborator
(none)
351
Enrollment
4
Arms
3
Duration (Months)

Study Details

Study Description

Brief Summary

This study was conducted to see if mometasone nasal spray is efficaceous for the treatment of perennial allergic rhinitis. Patients will be randomized to active mometasone, placebo mometasone, active fluticasone, or placebo fluticasone.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
351 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis
Study Start Date :
Sep 1, 2005
Actual Primary Completion Date :
Nov 1, 2005
Actual Study Completion Date :
Dec 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Mometasone Furoate Placebo (PLAMF)

Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray

Drug: Placebo for MF
Placebo to mometasone furoate nasal spray, indistinguishable from mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks
Placebo Comparator: Fluticasone Propionate Placebo (PLAFP)

Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray

Drug: Placebo for FP
Placebo to fluticasone nasal spray, indistinguishable from fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks
Experimental: Mometasone Furoate (MF)

Mometasone furoate nasal spray 200 μg/day(QD)

Drug: Mometasone
Mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks
Other Names:
  • SCH 032088
  • Nasonex

    		•
    Active Comparator: Fluticasone Propionate (FP)

    Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)

    Drug: Fluticasone
    Fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks
    Other Names:
  • Flonase

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks [Baseline to 2 weeks of treatment]

      The nasal symptoms (sneezing attacks, rhinorrhea, nasal congestion and itching) were rated in 4 grades (+++: 3 points, ++: 2 points, +: 1 point, -: 0 point) based on the evaluation criteria for nasal symptoms. Total possible best score is 0 points, total possible worst score is 12 points.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Patients with perennial allergic rhinitis meeting all of the followings.

    • Patients with symptoms of perennial allergic rhinitis, the severity of which is moderate or severer according to the severity grading provided in the "Guidelines for the Management of Allergic Rhinitis in Japan" (partly modified) with the 4-nasal symptom score of 4 or over at informed consent and during the pre-treatment observation period

    • Patients with positive reaction to the eosinophil count in nasal discharge or nasal challenge test in addition to the skin test or specific IgE antibody test

    • Outpatients aged 16 years or over at informed consent

    • Patients in either sex

    • Patients (or their legal representatives in case of patients aged under 20 years) capable of giving written informed consent

    • Patients capable of recording nasal allergy diary every day

    Exclusion Criteria:

    • Patients with a complication of tuberculous diseases or lower respiratory tract infections, and those with a complication of otorhinolaryngeal infections(acute upper respiratory tract inflammation, acute laryngopharyngitis, acute tonsillitis, etc.) requiring treatments judged by the investigator (subinvestigator) at the time of enrollment to randomization

    • Patients with a complication of infection or systemic mycosis for which no effective antibiotics are available

    • Patients with a complication of recurrent epistaxis

    • Patients with uncured nasal septal ulcer, operated nose or nasal trauma.

    • Patients with a history of hypersensitivity to steroids and any ingredients of the study drugs

    • Pregnant, lactating or possibly pregnant patients or the patients who themselves or whose partners wish to become pregnant during the study

    • Patients with severe hepatic or renal disorder, heart or blood disease, diabetes mellitus, hypertension, or other serious complication, suffering from problems with systemic condition

    • Patients who have pollens as multiple allergens and the period from 7 days before enrollment to randomization to completion of the treatment period coincides with the period of scattering of relevant pollens

    • Patients with a complication of vasomotor rhinitis or eosinophilic rhinitis

    • Patients with a complication of a nasal disease (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, or septal deviation) which may interfere with efficacy evaluation of the study drugs

    • Patients with a complication of a disease (acute upper respiratory tract inflammation, acute laryngitis or acute tonsillitis, etc.) of severity affecting nasal symptoms within 7 days before enrollment

    • Patients who have previously received MF nasal spray

    • Patients who used FP nasal spray within 28 days before initiation of the pre-treatment observation period (7 days before enrollment to randomization)

    • Patients who have participated in clinical trials of other investigational product(s) within 120 days (4 months) before obtaining informed consent or participating at present

    • Patients in whom prior medication expected to be effective for allergic rhinitis was not drawn long enough before initiation of treatment with the investigational product or the preceding medication cannot be withdrawn

    • Patients who are being treated with specific desensitization therapy or nonspecific allassotherapy or in whom such the therapy was withdrawn within 90 days (3 months) before obtaining informed consent (except for patients receiving the maintenance therapy at present in whom the therapy began more than 180 days (6 months) before obtaining the informed consent)

    • Other patients whom the investigator or the subinvestigator judged to be inappropriate for participation in the present study

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT00783224
    Other Study ID Numbers:
    • P04512
    First Posted:
    Oct 31, 2008
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Rhinitis
    Rhinitis, Allergic
    Rhinitis, Allergic, Perennial
    Fluticasone
    Mometasone Furoate

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Mometasone Furoate Placebo (PLAMF) Fluticasone Propionate Placebo (PLAFP) Mometasone Furoate (MF) Fluticasone Propionate (FP)
    Arm/Group Description Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray Mometasone furoate nasal spray 200 μg/day(QD) Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
    Period Title: Overall Study
    STARTED 32 34 143 142
    COMPLETED 32 34 142 140
    NOT COMPLETED 0 0 1 2

    Baseline Characteristics

    Arm/Group Title Mometasone Furoate Placebo (PLAMF) Fluticasone Propionate Placebo (PLAFP) Mometasone Furoate (MF) Fluticasone Propionate (FP) Total
    Arm/Group Description Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray Mometasone furoate nasal spray 200 μg/day(QD) Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID) Total of all reporting groups
    Overall Participants 32 34 143 142 351
    Age, Customized (participants) [Number]
    <20 years old
    1
    3.1%
    0
    0%
    7
    4.9%
    11
    7.7%
    19
    5.4%
    20-29 years old
    20
    62.5%
    13
    38.2%
    59
    41.3%
    76
    53.5%
    168
    47.9%
    30-39 years old
    11
    34.4%
    16
    47.1%
    54
    37.8%
    33
    23.2%
    114
    32.5%
    40-59 years old
    0
    0%
    5
    14.7%
    19
    13.3%
    21
    14.8%
    45
    12.8%
    >=60 years old
    0
    0%
    0
    0%
    4
    2.8%
    1
    0.7%
    5
    1.4%
    Sex: Female, Male (Count of Participants)
    Female
    20
    62.5%
    24
    70.6%
    99
    69.2%
    87
    61.3%
    230
    65.5%
    Male
    12
    37.5%
    10
    29.4%
    44
    30.8%
    55
    38.7%
    121
    34.5%

    Outcome Measures

    1. Primary Outcome
    Title Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks
    Description The nasal symptoms (sneezing attacks, rhinorrhea, nasal congestion and itching) were rated in 4 grades (+++: 3 points, ++: 2 points, +: 1 point, -: 0 point) based on the evaluation criteria for nasal symptoms. Total possible best score is 0 points, total possible worst score is 12 points.
    Time Frame Baseline to 2 weeks of treatment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Mometasone Furoate Placebo (PLAMF) Fluticasone Propionate Placebo (PLAFP) Mometasone Furoate (MF) Fluticasone Propionate (FP)
    Arm/Group Description Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray Mometasone furoate nasal spray 200 μg/day(QD) Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
    Measure Participants 32 34 143 142
    Baseline
    7.84
    (0.25)
    8.41
    (0.29)
    8.27
    (0.15)
    8.29
    (0.16)
    Two Weeks
    1.63
    (0.37)
    1.74
    (0.35)
    3.90
    (0.17)
    3.69
    (0.17)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Placebo (PLAMF), Mometasone Furoate (MF)
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate Placebo (PLAFP), Fluticasone Propionate (FP)
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments
    Method ANCOVA
    Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Mometasone Furoate Placebo and Fluticasone Propionate Placebo Mometasone Furoate (MF) Fluticasone Propionate (FP)
    Arm/Group Description Both placebo groups (arms) were combined to report adverse events Mometasone furoate nasal spray 200 μg/day(QD) Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
    All Cause Mortality
    Mometasone Furoate Placebo and Fluticasone Propionate Placebo Mometasone Furoate (MF) Fluticasone Propionate (FP)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Mometasone Furoate Placebo and Fluticasone Propionate Placebo Mometasone Furoate (MF) Fluticasone Propionate (FP)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/66 (0%) 0/143 (0%) 1/142 (0.7%)
    Surgical and medical procedures
    Wisdom Teeth Removal 0/66 (0%) 0 0/143 (0%) 0 1/142 (0.7%) 1
    Other (Not Including Serious) Adverse Events
    Mometasone Furoate Placebo and Fluticasone Propionate Placebo Mometasone Furoate (MF) Fluticasone Propionate (FP)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/66 (6.1%) 11/143 (7.7%) 4/142 (2.8%)
    Respiratory, thoracic and mediastinal disorders
    Upper Respiratory Tract Inflammation 4/66 (6.1%) 4 11/143 (7.7%) 11 4/142 (2.8%) 4

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only restriction on the PI is that the PI needs to get approval from the sponsor for publication of the trial results prior to public release.

    Results Point of Contact

    Name/Title Senior Vice President, Global Clinical Development
    Organization Merck, Sharp & Dohme Corp.
    Phone
    Email ClinicalTrialsDisclosure@merck.com
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT00783224
    Other Study ID Numbers:
    • P04512
    First Posted:
    Oct 31, 2008
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Feb 1, 2022