Seasonal Allergic RhinitisPhase 3NCT02125253
Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg With Nasonex Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
A Phase 3 study testing Mometasone Furoate Nasal Spray, 50 mcg and Nasonex Nasal Spray, 50 mcg in people with Seasonal Allergic Rhinitis, run by Amneal Pharmaceuticals, LLC at 10 sites in United States.
Trial summary
To evaluate the therapeutic equivalence of the lest formulation of Mometasone Furoate Nasal Spray, 50 mcg to the marketed formulation NASONEX® (mometasone furoate monohydrate) Nasal Spray, 50 mcg/actuation in patients with seasonal allergic rhinitis Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Mometasone Furoate Nasal Spray, 50 mcg and Nasonex Nasal Spray, 50 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 811 participants
- Where
- 10 sitesUnited States
- Study dates
- Jan 2014to Jun 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- If female and of child-bearing potential, have a negative urine pregnancy test and is prepared to abstain from sexual intercourse or use a reliable method of contraception during the study
- Documented positive allergic skin test, performed within the previous 12 months, to one or more of the allergens in season at the time the study is being conducted.
- A minimum of two consecutive years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
- A score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) and a minimum score of at least 2 for "nasal congestion" and a minimum score of at least 2 for one of the remaining 3 symptoms representing the 12hours prior to the screening visit.
- An average composite score of at least 6 on the rTNSS and a minimum score of at least 2 for "nasal congestion" and a minimum score of at least 2 for one of the remaining 3 symptoms representing the last 3 days of the 7-day placebo lead-in period before the randomization visit and the morning of the first day.
- of the randomization visit.
Who cannot join
- Females who are pregnant, lactating or likely to become pregnant during the study.
- Negative or lack of documented skin allergen test (performed within the previous 12 months) to at least one of the allergens in season at the time the study is being conducted.
- Patients who suffer from chronic signs and symptoms of Perennial Allergic Rhinitis, unless the investigator assesses that the patient's current signs and symptoms are a clear exacerbation of Seasonal Allergic Rhinitis (SAR) rather than chronic PAR.
- Patients who suffer only from perennial allergic rhinitis or seasonal allergic rhinitis to a different allergen than that in season at the time the study is conducted.
- Previous history of less than 2 years of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
- Any patient who meets the minimum rTNSS requirements at the start of the placebo lead-in period but no longer meets the requirements prior to the randomized active treatment period of the study cannot continue in the active treatment period.
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- History of asthma over the previous two years that required chronic therapy. Occasional acute or mild exercise induced asthma will be allowable on the condition that the treatment of the attacks is restricted to beta-agonists only.
- Patients with nasal conditions, including infectious rhinitis, rhinitis medicamentosa or atrophic rhinitis.
- Clinically significant nasal deformity or any recent nasal surgery or trauma that has not completely healed.
- Sinus infection within the previous 30 days or history of reoccurring sinus infections.
- Patient has started immunotherapy or changed their dose of immunotherapy within 30 days of the first placebo lead-in dose or is likely to have to start immunotherapy, or change their current dose during the study.
- Treatment for oral Candidiasis within 30 days of starting the study or a current oral Candidiasis infection.
- Upper respiratory tract infection within the previous 30 days.
- Patients with a history of tuberculosis.
- Patients with the presence of glaucoma, cataracts, ocular herpes simplex, conjunctivitis or other eye infection not related to the diagnosis of SAR within 14 days of enrollment.
- The patient has had recent exposure (30 days) or was at risk of being exposed to chicken pox or measles.
- Patients with any untreated fungal, bacterial, systemic viral infections within the previous 30 days.
- Use of any ophthalmic steroids within 14 days or nasal, inhaled or systemic steroids within 30 days of the study start.
- Use of the reference product, Nasonex® within 3 months of the study start.
- Use of intranasal or systemic second-generation anti-histamines within10 days of enrollment.
- Use of intranasal cromolyn within 14 days of enrollment.
- Use of intranasal or systemic first-generation anti-histamines, leukotriene receptor antagonists or other nasal decongestants within 3 days of enrollment.
- Use of any tricyclic anti-depressant within 30 days of enrollment
- Patients with attention-deficit disorder being treated with methylphenidate containing products that have not been on a stable dosing regimen for at least the 30 previous days and who cannot remain on the same dosing regimen throughout the study.
- Desensitization therapy to the seasonal allergen that is causing the patients allergic rhinitis within the previous 6 months.
- Previous SAR and/or PAR that has proven unresponsive to steroid therapy.
- Any known hypersensitivity to mometasone, other steroids or any of the components of the study nasal spray.
- Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participating or could jeopardize the integrity of the study evaluations.
- Receipt of any drug as part of a research study within 30 days prior to the first placebo lead-in dose.
- Planned travel outside of the local area for more than 2 consecutive days or 3 days in total, during the patient's participation in the study.
- Previous participation in this study.
- The patient currently smokes cigarettes, cigars, and/or pipes and is a heavy smoker
- The patient shares a household with another patient currently enrolled in this study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Isis Clinical Research
Austin, Texas, 78731
Austin Clinical Research
Austin, Texas, 78750
Sirius Clinical Research
Austin, Texas, 78759
Kerrville Research Associates
Kerrville, Texas, 78028
Central Texas Health Research
New Braunfels, Texas, 78130
Allergy & Asthma Research Center
San Antonio, Texas, 78229
Biogenics Research Institute
San Antonio, Texas, 78229
Diagnostics Research Group
San Antonio, Texas, 78229
Sylvania Research
San Antonio, Texas, 78229
Allergy & Asthma Care of Waco
Waco, Texas, 76708
About this study
Official title: A Blinded, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg (Amneal Pharmaceuticals LLC) With NASONEX® Nasal Spray (Schering Corporation) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
To evaluate the therapeutic equivalence of the lest formulation of Mometasone Furoate Nasal Spray, 50 mcg to the marketed formulation NASONEX® (mometasone furoate monohydrate) Nasal Spray, 50 mcg/actuation in patients with seasonal allergic rhinitis
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Mometasone Furoate Nasal Spray, 50 mcg, Nasonex Nasal Spray, 50 mcg, Placebo Nasal Spray
- 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 Spray, 50 mcgDrug
a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate
Nasonex Nasal Spray, 50 mcgDrug
a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate
Placebo Nasal SprayDrug
a metered-dose, manual pump spray unit containing an aqueous suspension
| Study group | Role | What they receive |
|---|---|---|
| Mometasone Furoate Nasal Spray, 50 mcg | Experimental | Mometasone Furoate Nasal Spray, 50 mcg. 4 actuations per day for 14 days. Receives: Drug: Mometasone Furoate Nasal Spray, 50 mcg |
| Nasonex Nasal Spray, 50 mcg | Active comparator | Nasonex (mometasone furoate monohydrate) Nasal Spray, 50 mcg. 4 actuations per day for 14 days. Receives: Drug: Nasonex Nasal Spray, 50 mcg |
| Placebo Nasal Spray | Placebo comparator | Placebo of Mometasone Furoate Nasal Spray. 4 actuations per day for 14 days. Receives: Drug: Placebo Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline rTNSS
Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS) over Days 1 to 14
Measured: Days 1 - 14
Total Nasal Symptom Score (TNSS)
The sum of patient-rated severity scores for four allergy symptoms : runny nose, nasal congestion, itchy nose, and sneezing based on a 4-point scale.
Measured: Days 1 - 14
Secondary outcomes (1)
Change in Baseline iTNSS
Change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS) over Days 1 to 14.
Measured: Days 1 - 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 811 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amneal Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Responsible party
- Sponsor
- Investigators
- Keith Gallicano, PhD, Study chair, Novum Pharmaceutical Reserach Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125253
- Sponsor's protocol ID
- AM-MMS-001
- Status last verified
- Oct 2015
- First submitted
- 25 Apr 2014
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg (Amneal Pharmaceuticals LLC) With NASONEX® Nasal Spray (Schering Corporation) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02125253
- Acronym / sponsor ID
- AM-MMS-001
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 811 participants (actual)
- Lead sponsor
- Amneal Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 Apr 2014 (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.
To evaluate the therapeutic equivalence of the lest formulation of Mometasone Furoate Nasal Spray, 50 mcg to the marketed formulation NASONEX® (mometasone furoate monohydrate) Nasal Spray, 50 mcg/actuation in patients with seasonal allergic rhinitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mometasone Furoate Nasal Spray, 50 mcg | Experimental | Drug: Mometasone Furoate Nasal Spray, 50 mcgMometasone Furoate Nasal Spray, 50 mcg. 4 actuations per day for 14 days. |
| Nasonex Nasal Spray, 50 mcg | Active comparator | Drug: Nasonex Nasal Spray, 50 mcgNasonex (mometasone furoate monohydrate) Nasal Spray, 50 mcg. 4 actuations per day for 14 days. |
| Placebo Nasal Spray | Placebo comparator | Drug: Placebo Nasal SprayPlacebo of Mometasone Furoate Nasal Spray. 4 actuations per day for 14 days. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- If female and of child-bearing potential, have a negative urine pregnancy test and is prepared to abstain from sexual intercourse or use a reliable method of contraception during the study
- Documented positive allergic skin test, performed within the previous 12 months, to one or more of the allergens in season at the time the study is being conducted.
- A minimum of two consecutive years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
- A score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) and a minimum score of at least 2 for "nasal congestion" and a minimum score of at least 2 for one of the remaining 3 symptoms representing the 12hours prior to the screening visit.
- An average composite score of at least 6 on the rTNSS and a minimum score of at least 2 for "nasal congestion" and a minimum score of at least 2 for one of the remaining 3 symptoms representing the last 3 days of the 7-day placebo lead-in period before the randomization visit and the morning of the first day.
Key exclusion criteria (33 listed)
- Females who are pregnant, lactating or likely to become pregnant during the study.
- Negative or lack of documented skin allergen test (performed within the previous 12 months) to at least one of the allergens in season at the time the study is being conducted.
- Patients who suffer from chronic signs and symptoms of Perennial Allergic Rhinitis, unless the investigator assesses that the patient's current signs and symptoms are a clear exacerbation of Seasonal Allergic Rhinitis (SAR) rather than chronic PAR.
- Patients who suffer only from perennial allergic rhinitis or seasonal allergic rhinitis to a different allergen than that in season at the time the study is conducted.
- Previous history of less than 2 years of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
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 Spray, 50 mcga metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate | Drug | Mometasone Furoate Nasal Spray, 50 mcg |
| Nasonex Nasal Spray, 50 mcga metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate | Drug | Nasonex Nasal Spray, 50 mcg |
| Placebo Nasal Spraya metered-dose, manual pump spray unit containing an aqueous suspension | Drug | Placebo Nasal Spray |
Primary outcome
Change from Baseline rTNSS
Time frame: Days 1 - 14
Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS) over Days 1 to 14
Total Nasal Symptom Score (TNSS)
Time frame: Days 1 - 14
The sum of patient-rated severity scores for four allergy symptoms : runny nose, nasal congestion, itchy nose, and sneezing based on a 4-point scale.
1 secondary outcome
Change in Baseline iTNSS
Time frame: Days 1 - 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
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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.
Keith Gallicano, PhD study chair
Novum Pharmaceutical Reserach Services
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mometasone Furoate Nasal Spray, 50 mcg and Nasonex Nasal Spray, 50 mcg in people with Seasonal Allergic Rhinitis, run by Amneal Pharmaceuticals, LLC at 10 sites in United States.
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 6 inclusion and 33 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 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 rTNSS (time frame: Days 1 - 14). The study lists 2 primary outcomes in all. 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 2 Nov 2015.