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Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161)

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ClinicalTrials.gov Identifier: NCT03879772
Recruitment Status : Completed
First Posted : March 19, 2019
Results First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study was to identify the lowest dosage of mometasone furoate nasal spray (MFNS) that provided adequate efficacy with an acceptable safety profile for children (ages 6-11) with seasonal allergic rhinitis (SAR). The MFNS dose levels of 25, 100, and 200 mcg QD were compared with beclomethasone dipropionate (BDP), as an active control, and placebo.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Seasonal Drug: Mometasone furoate nasal spray Drug: Beclomethasone dipropionate nasal spray Drug: Placebo nasal spray Drug: Chlorpheniramine maleate syrup Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 679 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Dose-Ranging Study of Mometasone Furoate Nasal Spray (SCH 32088) in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (Protocol C95-161)
Actual Study Start Date : March 12, 1996
Actual Primary Completion Date : July 1, 1996
Actual Study Completion Date : July 1, 1996

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Experimental: MFNS 25 mcg QD
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Drug: Mometasone furoate nasal spray
intranasal administration
Other Names:
  • Nasonex®
  • MK-0887
  • SCH 032088

Drug: Placebo nasal spray
intranasal administration

Drug: Chlorpheniramine maleate syrup
oral administration
Other Name: ChlorTrimeton Syrup

Experimental: MFNS 100 mcg QD
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Drug: Mometasone furoate nasal spray
intranasal administration
Other Names:
  • Nasonex®
  • MK-0887
  • SCH 032088

Drug: Placebo nasal spray
intranasal administration

Drug: Chlorpheniramine maleate syrup
oral administration
Other Name: ChlorTrimeton Syrup

Experimental: MFNS 200 mcg QD
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Drug: Mometasone furoate nasal spray
intranasal administration
Other Names:
  • Nasonex®
  • MK-0887
  • SCH 032088

Drug: Placebo nasal spray
intranasal administration

Drug: Chlorpheniramine maleate syrup
oral administration
Other Name: ChlorTrimeton Syrup

Active Comparator: BDP 84 mcg BID
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Drug: Beclomethasone dipropionate nasal spray
intranasal administration
Other Name: Vancenase®

Drug: Chlorpheniramine maleate syrup
oral administration
Other Name: ChlorTrimeton Syrup

Placebo Comparator: Placebo
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Drug: Placebo nasal spray
intranasal administration

Drug: Chlorpheniramine maleate syrup
oral administration
Other Name: ChlorTrimeton Syrup




Primary Outcome Measures :
  1. Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator [ Time Frame: Baseline (Day 1) and Day 8 ]
    The mean change from baseline at study day 8 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.


Secondary Outcome Measures :
  1. Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator [ Time Frame: Baseline (Day 1) and Day 4 ]
    The mean change from baseline at study day 4 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.

  2. Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator [ Time Frame: Baseline (Day 1) and Day 15 ]
    The mean change from baseline at study day 15 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.

  3. Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator [ Time Frame: Baseline (Day 1) and Day 29 ]
    The mean change from baseline at study day 29 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.

  4. Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant [ Time Frame: Baseline and Days 1 through 15 (average over 15 days) ]
    Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain 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 were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity.

  5. Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant [ Time Frame: Baseline and Days 16 through 29 (average over 15 days) ]
    Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain 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 were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity.



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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have at least a one-year history of seasonal allergic rhinitis which previously required treatment for tree and/or grass pollen
  • Have a positive skin test response to an appropriate tree and/or grass seasonal allergen within the last year.
  • Must be free of any clinically significant disease other than seasonal allergic rhinitis.
  • Must be pre-menarcheal.

Exclusion Criteria:

  • History of asthma which requires chronic use of inhaled or systemic corticosteroids.
  • Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
  • History of rhinitis medicamentosa.
  • History of clinically significant nasal candidiasis.
  • History of multiple drug allergies or allergy/intolerance to corticosteroids or antihistamines.
  • History of upper respiratory tract or sinus infection that required antibiotic therapy within the previous 2 weeks, or viral upper respiratory infection within 7 days prior to Screening.
  • History of nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow.
  • History of dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines.
  • History of investigational drug use in the last 30 days.
  • History of immunotherapy (desensitizing therapy), unless on a stable maintenance schedule for at least one month prior to Screening.

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): NCT03879772


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03879772     History of Changes
Other Study ID Numbers: C95-161
C95-161 ( Other Identifier: Schering-Plough Protocol Number )
First Posted: March 19, 2019    Key Record Dates
Results First Posted: August 12, 2019
Last Update Posted: August 12, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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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
Chlorpheniramine
Beclomethasone
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Antipruritics
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents