Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03855228
Recruitment Status : Completed
First Posted : February 26, 2019
Results First Posted : July 26, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of mometasone furoate nasal spray (MFNS) with the addition of loratadine vs MFNS alone, loratadine alone, or placebo, in the treatment of patients with seasonal allergic rhinitis.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic Drug: Mometasone furoate nasal spray (MFNS) Drug: Loratadine Drug: Placebo nasal spray Drug: Placebo tablet Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 704 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in the Treatment of Seasonal Allergic Rhinitis (Study No. C94-145)
Actual Study Start Date : March 1, 1995
Actual Primary Completion Date : August 7, 1995
Actual Study Completion Date : August 7, 1995

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Experimental: MFNS 200 µg + Loratadine 10 mg
Daily administration of 200 µg of MFNS plus oral dose of 10 mg loratadine tablet.
Drug: Mometasone furoate nasal spray (MFNS)
Daily dose of 200 µg of mometasone furoate administered as a nasal spray for 15 days.
Other Names:
  • SCH 32088
  • MK-0887
  • NASONEX®

Drug: Loratadine
Daily dose of 10 mg of loratadine administered as an oral tablet for 15 days.
Other Name: Claritin®

Active Comparator: MFNS 200 µg
Daily administration of 200 µg of MFNS plus oral placebo tablet.
Drug: Mometasone furoate nasal spray (MFNS)
Daily dose of 200 µg of mometasone furoate administered as a nasal spray for 15 days.
Other Names:
  • SCH 32088
  • MK-0887
  • NASONEX®

Drug: Placebo tablet
Daily dose of placebo administered as an oral tablet for 15 days.

Active Comparator: Loratadine 10 mg
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
Drug: Loratadine
Daily dose of 10 mg of loratadine administered as an oral tablet for 15 days.
Other Name: Claritin®

Drug: Placebo nasal spray
Daily dose of placebo administered as a nasal spray for 15 days.

Placebo Comparator: Placebo
Daily administration of placebo nasal spray plus oral placebo tablet.
Drug: Placebo nasal spray
Daily dose of placebo administered as a nasal spray for 15 days.

Drug: Placebo tablet
Daily dose of placebo administered as an oral tablet for 15 days.




Primary Outcome Measures :
  1. Change From Baseline in Total Nasal Symptom Score (Assessed by Participant) [ Time Frame: Baseline and days 1 through 15 (average of 15 days of treatment) ]

    Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total nasal symptom scores assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total nasal symptom score (range: 0-12); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB.

    CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.


  2. Change From Baseline in Total Symptom Score (Assessed by Participant) [ Time Frame: Baseline and days 1 through 15 (average of 15 days of treatment) ]

    Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total symptom scores assessed by participants. Participants scored 8 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing; itching/burning eyes; tearing/watering eyes; eye redness; and ear/palate itching) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total symptom score (range: 0-24); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB.

    CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.



Secondary Outcome Measures :
  1. Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician) [ Time Frame: Baseline and study day 15 ]

    The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity.

    A negative change from baseline indicates a decrease in symptom severity.


  2. Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician) [ Time Frame: Baseline and study day 15 ]

    The mean change from baseline on study day 15 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity.

    A negative change from baseline indicates a decrease in symptom severity.


  3. Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician) [ Time Frame: Baseline and study day 8 ]

    The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity.

    A negative change from baseline indicates a decrease in symptom severity.


  4. Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician) [ Time Frame: Baseline and study day 8 ]

    The mean change from baseline on study day 8 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity.

    A negative change from baseline indicates a decrease in symptom severity.


  5. Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician) [ Time Frame: Baseline and study day 15 ]

    The mean change from baseline on study day 15 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity.

    A negative change from baseline indicates a decrease in symptom severity.


  6. Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 8 (Assessed by Physician) [ Time Frame: Baseline and study day 8 ]

    The mean change from baseline on study day 8 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity.

    A negative change from baseline indicates a decrease in symptom severity.


  7. Response to Therapy on Day 15 (Assessed by Physician) [ Time Frame: Study day 15 ]
    Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 15. A higher value indicates weaker response.

  8. Response to Therapy on Day 8 (Assessed by Physician) [ Time Frame: Study day 8 ]
    Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 8. A higher value indicates weaker response.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 2-year history of seasonal allergic rhinitis
  • Positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
  • Good health and free of any unstable, clinically significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Women of childbearing potential who are not using an acceptable form of birth control
  • Significant history of metabolic, cardiovascular, neurologic, hematologic, hepatic, gastrointestinal, cerebrovascular, respiratory, or renal disease, or any other disorder which, in the judgment of the investigator, could interfere with the study, or require treatment which might interfere with the study
  • Use of any chronic medication which could affect the course of seasonal allergic rhinitis
  • Asthma requiring chronic use of inhaled or systemic corticosteroids (inhaled bronchodilators are permitted for asthma treatment)
  • Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip
  • Upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks, or a viral upper respiratory infection (URI) within the 7 days prior to Screening
  • Dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
  • Has rhinitis medicamentosa
  • Evidence of clinically significant nasal candidiasis
  • Investigational drug use within the previous 30 days
  • Nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow
  • Immunotherapy (desensitization therapy), unless on a stable maintenance schedule for at least one month prior to the Screening visit
  • History of multiple drug allergies, allergy to antihistamines or corticoids
  • History of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855228


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.

Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03855228     History of Changes
Other Study ID Numbers: C94-145
C94-145 ( Other Identifier: Schering-Plough Corporation Protocol Number )
First Posted: February 26, 2019    Key Record Dates
Results First Posted: July 26, 2019
Last Update Posted: August 14, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone Furoate
Loratadine
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs