Allergic RhinitisPhase 3NCT02953379
Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis
A Phase 3 study testing EMS Mometasone gel and Mometasone spray nasal in people with Allergic Rhinitis, run by EMS.
Trial summary
The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the mometasone nasal gel in the treatment of allergic rhinitis. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- EMS Mometasone gel and Mometasone spray nasal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Mar 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed Consent of the patient;
- Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma);
Who cannot join
- Patients with any clinically significant disease that in the investigator is opinion can
- ´t participate in the study;
- Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
- Patients with history of hypersensitivity to any of the formula compounds;
- Participation in clinical trial in the year prior to this study;
- Pregnancy or risk of pregnancy and lactating patients;
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- Patients who were in use of drugs that can interfere with evaluation;
- Decongestants dependent patients or patients receiving allergen specific immunotherapy;
- Patients on treatment with monoamine oxidase inhibitors (MAOIs);
- History of hypertension, coronary artery disease, cardiac arrhythmias, glaucoma, hyperthyroidism and / or prostatic hypertrophy.
About this study
Official title: Phase III, National, Multicenter, Randomized, Single-blind, Non-inferiority to Compare the Efficacy of Mometasone Nasal Gel Compared to Mometasone Nasal Spray in the Treatment of Persistent or Intermittent Allergic Rhinitis in Adults
The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the mometasone nasal gel in the treatment of allergic rhinitis.
- Conditions
- Allergic Rhinitis
- Being tested
- EMS Mometasone gel, Mometasone spray nasal
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMS Mometasone gelDrug
The patient should administer 2 spray in each nostril, once daily.
Mometasone spray nasalDrug
Also called Nasonex
The patient should administer 2 spray in each nostril, once daily.
| Study group | Role | What they receive |
|---|---|---|
| EMS Mometasone gel | Experimental | The patient should administer 2 spray in each nostril, once daily. Receives: Drug: EMS Mometasone gel |
| Mometasone spray nasal | Active comparator | The patient should administer 2 spray in each nostril, once daily. Receives: Drug: Mometasone spray nasal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief
Measured: 14 days
Secondary outcomes (1)
Safety will be evaluated by the adverse events occurrences
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startMay 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionMar 2020 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953379
- Sponsor's protocol ID
- EMS1315
- Status last verified
- Nov 2020
- First submitted
- 1 Nov 2016
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, National, Multicenter, Randomized, Single-blind, Non-inferiority to Compare the Efficacy of Mometasone Nasal Gel Compared to Mometasone Nasal Spray in the Treatment of Persistent or Intermittent Allergic Rhinitis in Adults
- ClinicalTrials.gov ID
- NCT02953379
- Acronym / sponsor ID
- EMS1315
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- May 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
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 non-inferiority of the clinical efficacy of the mometasone nasal gel in the treatment of allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMS Mometasone gel | Experimental | Drug: EMS Mometasone gelThe patient should administer 2 spray in each nostril, once daily. |
| Mometasone spray nasal | Active comparator | Drug: Mometasone spray nasalThe patient should administer 2 spray in each nostril, once daily. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Signed Consent of the patient;
- Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma);
Key exclusion criteria (10 listed)
- Patients with any clinically significant disease that in the investigator is opinion can
- ´t participate in the study;
- Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
- Patients with history of hypersensitivity to any of the formula compounds;
- Participation in clinical trial in the year prior to this study;
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 |
|---|---|---|
| EMS Mometasone gelThe patient should administer 2 spray in each nostril, once daily. | Drug | EMS Mometasone gel |
| Mometasone spray nasalAlso: NasonexThe patient should administer 2 spray in each nostril, once daily. | Drug | Mometasone spray nasal |
Primary outcome
Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief
Time frame: 14 days
1 secondary outcome
Safety will be evaluated by the adverse events occurrences
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EMS Mometasone gel and Mometasone spray nasal in people with Allergic Rhinitis, run by EMS.
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 2 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: withdrawn, as of the sponsor's last update on 4 Nov 2020. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief (time frame: 14 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 4 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.