Rhinitis, Allergic, SeasonalPhase 3NCT03882047
Mometasone Furoate Aqueous (MK-0887/SCH 032088) Nasal Spray vs Placebo and FLONASE® in Seasonal Allergic Rhinitis Patients (I94-001)
A Phase 3 study testing Mometasone furoate and Fluticasone propionate in people with Rhinitis, Allergic, Seasonal, run by Organon and Co.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of mometasone furoate (SCH 32088) aqueous nasal spray 200 mcg once daily compared to placebo once daily in the treatment of participants with seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- Mometasone furoate and Fluticasone propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 313 participants
- Where
- No sites listed yet
- Study dates
- 11 Aug 1994to 16 Sep 1994
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
- 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
About this study
Official title: Efficacy and Safety of Mometasone Furoate Aqueous Nasal Spray vs Placebo and Flonase® (Fluticasone Propionate) in Seasonal Allergic Rhinitis Patients (I94-001)
The purpose of this study is to evaluate the efficacy and safety of mometasone furoate (SCH 32088) aqueous nasal spray 200 mcg once daily compared to placebo once daily in the treatment of participants with seasonal allergic rhinitis. Flonase (fluticasone propionate) nasal spray 200 mcg once daily has been chosen as the active control for this study.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- Mometasone furoate, Fluticasone propionate, Mometasone furoate placebo, Fluticasone propionate placebo
- 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 furoateDrug
Also called NASONEX®, MK-0887, SCH 032088
Mometasone furoate nasal spray, 200 mg once daily
Fluticasone propionateDrug
Also called FLONASE®
Fluticasone propionate nasal spray, 200 mg once daily
Mometasone furoate placeboDrug
Mometasone furoate placebo matching nasal spray, once daily
Fluticasone propionate placeboDrug
Fluticasone propionate placebo matching nasal spray, once daily
| Study group | Role | What they receive |
|---|---|---|
| Mometasone furoate nasal spray | Experimental | Participants receive 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily. Receives: Drug: Mometasone furoate; Drug: Fluticasone propionate placebo |
| Fluticasone propionate nasal spray | Active comparator | Participants receive 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily. Receives: Drug: Fluticasone propionate; Drug: Mometasone furoate placebo |
| Placebo nasal spray | Placebo comparator | Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily. Receives: Drug: Mometasone furoate placebo; Drug: Fluticasone propionate placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries)
Change from baseline averaged over study Day 1 through study Day 15 was calculated for Total Nasal Symptom Score, based on participant diaries. Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in their diaries using the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The Total Nasal Symptom Score was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) Change from baseline was the 15-day average score minus the baseline score. Scores were recorded twice daily, in the morning (AM) and night (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. Baseline score was an average of the 3 AM scores and 3 PM scores preceding treatment. Negative changes indicated a decrease in symptom severity.
Measured: Baseline and Day 1 through Day 15 (averaged over 15 days)
Secondary outcomes (10)
Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation)
Change from baseline at Day 4 was calculated for the Total Nasal Symptom Score, as assessed by the physician. The Total Nasal Symptom Score was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The physician scored each symptom during the study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Measured: Baseline (Day 1) and Day 4
Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation)
Change from baseline at Day 15 was calculated for the Total Nasal Symptom Score, as assessed by the physician. The Total Nasal Symptom Score was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The physician scored each symptom during the study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Measured: Baseline (Day 1) and Day 15
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation)
Change from baseline at Day 4 was calculated for the Overall Condition of Seasonal Allergic Rhinitis, as assessed by the physician. The physician scored their overall condition on study Day 4 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Measured: Baseline (Day 1) and Day 4
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation)
Change from baseline at Day 15 was calculated for the overall condition of seasonal allergic rhinitis, as assessed by the physician. The physician scored their overall condition on study Day 15 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Measured: Baseline (Day 1) and Day 15
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation)
The overall condition of seasonal allergic rhinitis was evaluated by the participant on Day 4, based on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Measured: Baseline (Day 1) and Day 4
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation)
The overall condition of seasonal allergic rhinitis was evaluated by the participant on Day 15, based on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Measured: Baseline (Day 1) and Day 15
Response to Therapy at Day 4 (Physician Evaluation)
Response to therapy was assessed by evaluating the participant's relief of nasal symptoms at Day 4. The physician evaluated the participant's response using the following 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.
Measured: Day 4
Response to Therapy at Day 15 (Physician Evaluation)
Response to therapy was assessed by evaluating the participant's relief of nasal symptoms at Day 15. The physician evaluated the participant's response using the following 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.
Measured: Day 15
Response to Therapy at Day 4 (Participant Evaluation)
Response to therapy was evaluated by participants and based upon their status scored at Day 4. Participants evaluated their response to therapy using the following 5-point scale: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.
Measured: Day 4
Response to Therapy at Day 15 (Participant Evaluation)
Response to therapy was evaluated by participants and based upon their status scored at Day 15. Participants evaluated their response to therapy using the following 5-point scale: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start11 Aug 1994
- Primary completion16 Sep 1994
- Study completion16 Sep 1994
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 313 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
- NCT03882047
- Sponsor's protocol ID
- I94-001
- Other IDs
- I94-001
- Status last verified
- Feb 2022
- First submitted
- 18 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
- Efficacy and Safety of Mometasone Furoate Aqueous Nasal Spray vs Placebo and Flonase® (Fluticasone Propionate) in Seasonal Allergic Rhinitis Patients (I94-001)
- ClinicalTrials.gov ID
- NCT03882047
- Acronym / sponsor ID
- I94-001
- Conditions
- Rhinitis, Allergic, Seasonal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 1994 (actual)
- Primary completion
- 16 Sep 1994 (actual)
- Study completion
- 16 Sep 1994 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Posted 6 Sep 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 is to evaluate the efficacy and safety of mometasone furoate (SCH 32088) aqueous nasal spray 200 mcg once daily compared to placebo once daily in the treatment of participants with seasonal allergic rhinitis. Flonase (fluticasone propionate) nasal spray 200 mcg once daily has been chosen as the active control for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mometasone furoate nasal spray | Experimental | Drug: Mometasone furoate, Drug: Fluticasone propionate placeboParticipants receive 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily. |
| Fluticasone propionate nasal spray | Active comparator | Drug: Fluticasone propionate, Drug: Mometasone furoate placeboParticipants receive 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily. |
| Placebo nasal spray | Placebo comparator | Drug: Mometasone furoate placebo, Drug: Fluticasone propionate placeboParticipants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
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 furoateAlso: NASONEX®, MK-0887, SCH 032088Mometasone furoate nasal spray, 200 mg once daily | Drug | Mometasone furoate nasal spray |
| Fluticasone propionateAlso: FLONASE®Fluticasone propionate nasal spray, 200 mg once daily | Drug | Fluticasone propionate nasal spray |
| Mometasone furoate placeboMometasone furoate placebo matching nasal spray, once daily | Drug | Fluticasone propionate nasal spray, Placebo nasal spray |
| Fluticasone propionate placeboFluticasone propionate placebo matching nasal spray, once daily | Drug | Mometasone furoate nasal spray, Placebo nasal spray |
Primary outcome
Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries)
Time frame: Baseline and Day 1 through Day 15 (averaged over 15 days)
Change from baseline averaged over study Day 1 through study Day 15 was calculated for Total Nasal Symptom Score, based on participant diaries. Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in their diaries using the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The Total Nasal Symptom Score was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) Change from baseline was the 15-day average score minus the baseline score. Scores were recorded twice daily, in the morning (AM) and night (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. Baseline score was an average of the 3 AM scores and 3 PM scores preceding treatment. Negative changes indicated a decrease in symptom severity.
10 secondary outcomes
Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation)
Time frame: Baseline (Day 1) and Day 4
Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation)
Time frame: Baseline (Day 1) and Day 15
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation)
Time frame: Baseline (Day 1) and Day 4
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation)
Time frame: Baseline (Day 1) and Day 15
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation)
Time frame: Baseline (Day 1) and Day 4
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation)
Time frame: Baseline (Day 1) and Day 15
Response to Therapy at Day 4 (Physician Evaluation)
Time frame: Day 4
Response to Therapy at Day 15 (Physician Evaluation)
Time frame: Day 15
Response to Therapy at Day 4 (Participant Evaluation)
Time frame: Day 4
Response to Therapy at Day 15 (Participant Evaluation)
Time frame: Day 15
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 and Fluticasone propionate 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 3 inclusion and 14 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 6 Sep 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 Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries) (time frame: Baseline and Day 1 through Day 15 (averaged over 15 days)). 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.