Rhinitis, Allergic, SeasonalPhase 3NCT03879772
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)
A Phase 3 study testing Mometasone furoate nasal spray, Beclomethasone dipropionate nasal spray and Chlorpheniramine maleate syrup in people with Rhinitis, Allergic, Seasonal, run by Organon and Co.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- Mometasone furoate nasal spray, Beclomethasone dipropionate nasal spray and Chlorpheniramine maleate syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 679 participants
- Where
- No sites listed yet
- Study dates
- 12 Mar 1996to 1 Jul 1996
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
About this study
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)
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.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- Mometasone furoate nasal spray, Beclomethasone dipropionate nasal spray, Placebo nasal spray, Chlorpheniramine maleate syrup
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone furoate nasal sprayDrug
Also called Nasonex®, MK-0887, SCH 032088
intranasal administration
Beclomethasone dipropionate nasal sprayDrug
Also called Vancenase®
intranasal administration
Placebo nasal sprayDrug
intranasal administration
Chlorpheniramine maleate syrupDrug
Also called ChlorTrimeton Syrup
oral administration
| Study group | Role | What they receive |
|---|---|---|
| MFNS 25 mcg QD | Experimental | 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. Receives: Drug: Mometasone furoate nasal spray; Drug: Placebo nasal spray; Drug: Chlorpheniramine maleate syrup |
| MFNS 100 mcg QD | Experimental | 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. Receives: Drug: Mometasone furoate nasal spray; Drug: Placebo nasal spray; Drug: Chlorpheniramine maleate syrup |
| MFNS 200 mcg QD | Experimental | 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. Receives: Drug: Mometasone furoate nasal spray; Drug: Placebo nasal spray; Drug: Chlorpheniramine maleate syrup |
| BDP 84 mcg BID | Active comparator | 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. Receives: Drug: Beclomethasone dipropionate nasal spray; Drug: Chlorpheniramine maleate syrup |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo nasal spray; Drug: Chlorpheniramine maleate syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator
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.
Measured: Baseline (Day 1) and Day 8
Secondary outcomes (5)
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator
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.
Measured: Baseline (Day 1) and Day 4
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator
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.
Measured: Baseline (Day 1) and Day 15
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator
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.
Measured: Baseline (Day 1) and Day 29
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
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.
Measured: Baseline and Days 1 through 15 (average over 15 days)
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
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.
Measured: Baseline and Days 16 through 29 (average over 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start12 Mar 1996
- Primary completion1 Jul 1996
- Study completion1 Jul 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 679 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879772
- Sponsor's protocol ID
- C95-161
- Other IDs
- C95-161
- Status last verified
- Feb 2022
- First submitted
- 15 Mar 2019
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03879772
- Acronym / sponsor ID
- C95-161
- Conditions
- Rhinitis, Allergic, Seasonal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 679 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 1996 (actual)
- Primary completion
- 1 Jul 1996 (actual)
- Study completion
- 1 Jul 1996 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Posted 12 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MFNS 25 mcg QD | Experimental | Drug: Mometasone furoate nasal spray, Drug: Placebo nasal spray, Drug: Chlorpheniramine maleate syrupMometasone 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. |
| MFNS 100 mcg QD | Experimental | Drug: Mometasone furoate nasal spray, Drug: Placebo nasal spray, Drug: Chlorpheniramine maleate syrupMometasone 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. |
| MFNS 200 mcg QD | Experimental | Drug: Mometasone furoate nasal spray, Drug: Placebo nasal spray, Drug: Chlorpheniramine maleate syrupMometasone 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. |
| BDP 84 mcg BID | Active comparator | Drug: Beclomethasone dipropionate nasal spray, Drug: Chlorpheniramine maleate syrupBeclomethasone 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. |
| Placebo | Placebo comparator | Drug: Placebo nasal spray, Drug: Chlorpheniramine maleate syrupMatching 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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mometasone furoate nasal sprayAlso: Nasonex®, MK-0887, SCH 032088intranasal administration | Drug | MFNS 100 mcg QD, MFNS 200 mcg QD, MFNS 25 mcg QD |
| Beclomethasone dipropionate nasal sprayAlso: Vancenase®intranasal administration | Drug | BDP 84 mcg BID |
| Placebo nasal sprayintranasal administration | Drug | MFNS 100 mcg QD, MFNS 200 mcg QD, MFNS 25 mcg QD, Placebo |
| Chlorpheniramine maleate syrupAlso: ChlorTrimeton Syruporal administration | Drug | BDP 84 mcg BID, MFNS 100 mcg QD, MFNS 200 mcg QD, MFNS 25 mcg QD, Placebo |
Primary outcome
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.
5 secondary outcomes
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
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
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
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mometasone furoate nasal spray, Beclomethasone dipropionate nasal spray and Chlorpheniramine maleate syrup in people with Rhinitis, Allergic, Seasonal, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.