Seasonal Allergic RhinitisPhase 3NCT01673659
A Safety and Bioequivalence of a Mometasone Nasal Spray, 50 mcg/Actuation Compared With Nasonex® Nasal Spray 50 mcg/Actuation in the Relief of the Symptoms of Seasonal Allergic Rhinitis (SAR)
A Phase 3 study testing Mometasone furoate and Nasonex Nasal Spray in people with Seasonal Allergic Rhinitis, run by Padagis LLC at 1 site in United States.
Trial summary
The objectives of this study is to demonstrate bioequivalence (comparable safety and efficacy) of the Test product to the Reference in the treatment of subjects seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Mometasone furoate and Nasonex Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,220 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Oct 2012
- 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
- Complete the informed consent/assent process.
- Male or female between 12-65 years of age.
- Female subjects of child-bearing potential must not be pregnant or nursing, must have a negative urine pregnancy test and abstain from sexual intercourse or use a reliable method of contraception during the study.
- Subjects will be eligible to participate if: a) Their total rTNSS is at least 6; b) Reflective rating for "nasal congestion/stuffy nose" is a score of >2 at Visit 1; c) Reflective score of >2 for at least one (1) of the remaining three (3) allergic rhinitis symptoms.
- A history (2 or more seasons) of seasonal allergy to at least one allergen known to be present during the study season, confirmed by a skin prick test. (A documented positive skin test within the previous 12 months is acceptable.)
Who cannot join
- Female who is pregnant or nursing, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study.
- Subject has a history of hypersensitivity or allergy to Mometasone, any other corticosteroids or any of the other study medication ingredients.
- Patients who suffer from chronic signs and symptoms of Perennial Allergic Rhinitis (PAR) should be excluded from the study, 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.
- A total score of less than 6 on the rTNSS or a score less than 2 for "nasal congestion" or a score less than 2 for all of the remaining 3 symptoms.
- Subject has any condition or abnormality of the upper airway (ex: nasal polyps, obstruction, recent nasal surgery, structural abnormality, rhinitis medicamentosa, etc.) that, in the opinion of the Investigator, could interfere with administration of the product, evaluation of the subject's condition, or other aspect of the trial.
- Subject has experienced any upper respiratory tract infection or has experienced a sinus infection within the 30 days, or has a history of recurrent sinus infections i.e. acute or significant chronic sinusitis, preceding Visit 1.
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- Subject has a history of asthma requiring chronic treatment within two years of study start.
- Subject lacks history of seasonal allergy to at least one allergen known to be present during the study season for at least the two preceding seasons.
- Subject has a negative skin test for all appropriate allergens known to be present during the study season.
- Treatment for oral Candidiasis within 30 days of starting the study, or a current oral Candidiasis infection.
- The subject has had recent exposure (30 days) or is at risk of being exposed to chicken pox or measles.
- Patients with any untreated fungal, bacterial, systemic viral infections within the previous 30 days.
- Subject requires treatment with systemic corticosteroids for any condition, or has received systemic or nasal steroids within the 30 days preceding Visit 1. Hormone replacement therapy is allowed, on condition that the subject has been on a stable dosing regimen for at least 90 days and remains on the same dosing regimen during the study.
- Subject used systemic anti-inflammatory agents* including aspirin and non-steroidal anti-inflammatory (NSAIDs) within 3 days prior to Visit 1. (*Subjects may use Acetaminophen for pain relief, as needed, throughout the study. Use of low-dose aspirin for cardiac prophylaxis is allowed).
- Subject had immunotherapy (including desensitization therapy to perennial allergens or seasonal allergens not found in the current season) initiated or the subject's dosage or frequency of immunotherapy has been adjusted within the 30 days preceding Visit 1.
- Subject had desensitization therapy to the seasonal allergen that is causing their allergic rhinitis within the previous 6 months.
- Subject presented with conjunctivitis or any other eye signs/symptoms that are not related to the diagnosis of SAR.
- Subject has used a topical (>1%) or ophthalmic steroid preparation within 14 days preceding Visit 1. (Topical steroid preparations used for dermatological indications are permitted in concentrations of ≤1%.)
- Use of intranasal or systemic first generation anti-histamines, leukotriene receptor antagonists (montelukast) or other nasal decongestants within 3 days of Visit 1.
- Use of intranasal cromolyn within 14 days of Visit 1.
- Use of intranasal or systemic second-generation antihistamines (e.g. fexofenadine, loratadine, desloratadine, cetirizine) within 10 days of Visit 1.
- Subject has received immune-system therapy with AIC (an investigational vaccine created using immunostimulatory sequences derived from DNA), SLIT, Oral peptide sequence at any time.
- Subject has clinically significant acute or chronic hepatic disease.
- Subject has a history of alcoholism, drug abuse, or problems which would likely make him/her unreliable for the study.
- Subject has any condition or uses any medication which, in the opinion of the Investigator, might interfere with the conduct or results of the study or place the prospective subject at increased risk.
- Subject has received tricyclic antidepressants within the 30 days preceding Visit 1.
- Subject has been treated for attention-deficit hyperactivity disorder with an unstable dose of a methylphenidate-containing products during the 30 days preceding Visit 1, or a dose adjustment is anticipated during the study.
- Subject or the subject's parent/legal guardian is unwilling to sign the informed consent form.
- Subject is concurrently participating in another investigational study or using any investigational drug (or biologic) or device within the 30 days prior to Visit 1.
- Subject plans or anticipates travel outside the allergen-rich area for more than one day during the Run-In phase (Visit 1-Visit 2), or for more than two consecutive and three total days during the Treatment Period (Visit 2-Visit 3). (Whenever possible, subjects should remain in the allergen-rich area for the 3 days preceding Visit 2 and Visit 3.)
- Subject has a history or presence of cataracts, ocular herpes, or glaucoma.
- Subject has a history of tuberculosis.
- Subject has previously enrolled in this study.
- Subject has used the Reference Product (Nasonex) within 3 months prior to Visit 1.
- History of unresponsiveness to Mometasone Nasal Spray.
- Members of the Investigational study staff, or family members of the Investigational study staff.
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this study is to demonstrate bioequivalence (comparable safety and efficacy) of the Test product to the Reference in the treatment of subjects seasonal allergic rhinitis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Mometasone furoate, Nasonex Nasal Spray, 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 furoateDrug
Nasonex Nasal SprayDrug
Placebo nasal sprayDrug
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Mometasone furoate 50 mcg/actuation Nasal Spray Receives: Drug: Mometasone furoate |
| Reference product | Active comparator | Nasonex Nasal Spray Receives: Drug: Nasonex Nasal Spray |
| Placebo Nasal Spray | Placebo comparator | vehicle of the test product Receives: Drug: Placebo nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline for mean reflective Total Nasal Symptom Score (rTNSS)
Measured: 2 week treatment period
Secondary outcomes (1)
Mean Change from Baseline in the mean Instantaneous Total Nasal Symptom Score (iTNSS)
Measured: 2 weeks treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2012
- Study completionOct 2012
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Padagis LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673659
- Sponsor's protocol ID
- PRG-NY-12-008
- Status last verified
- Oct 2021
- First submitted
- 23 Aug 2012
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Bioequivalence of a Mometasone Nasal Spray, 50 mcg/Actuation Compared With Nasonex® Nasal Spray 50 mcg/Actuation in the Relief of the Symptoms of Seasonal Allergic Rhinitis (SAR)
- ClinicalTrials.gov ID
- NCT01673659
- Acronym / sponsor ID
- PRG-NY-12-008
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,220 participants (actual)
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Aug 2012 (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 objectives of this study is to demonstrate bioequivalence (comparable safety and efficacy) of the Test product to the Reference in the treatment of subjects seasonal allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Drug: Mometasone furoateMometasone furoate 50 mcg/actuation Nasal Spray |
| Reference product | Active comparator | Drug: Nasonex Nasal SprayNasonex Nasal Spray |
| Placebo Nasal Spray | Placebo comparator | Drug: Placebo nasal sprayvehicle of the test product |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Complete the informed consent/assent process.
- Male or female between 12-65 years of age.
- Female subjects of child-bearing potential must not be pregnant or nursing, must have a negative urine pregnancy test and abstain from sexual intercourse or use a reliable method of contraception during the study.
- Subjects will be eligible to participate if: a) Their total rTNSS is at least 6; b) Reflective rating for "nasal congestion/stuffy nose" is a score of >2 at Visit 1; c) Reflective score of >2 for at least one (1) of the remaining three (3) allergic rhinitis symptoms.
- A history (2 or more seasons) of seasonal allergy to at least one allergen known to be present during the study season, confirmed by a skin prick test. (A documented positive skin test within the previous 12 months is acceptable.)
Key exclusion criteria (36 listed)
- Female who is pregnant or nursing, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study.
- Subject has a history of hypersensitivity or allergy to Mometasone, any other corticosteroids or any of the other study medication ingredients.
- Patients who suffer from chronic signs and symptoms of Perennial Allergic Rhinitis (PAR) should be excluded from the study, 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.
- A total score of less than 6 on the rTNSS or a score less than 2 for "nasal congestion" or a score less than 2 for all of the remaining 3 symptoms.
- Subject has any condition or abnormality of the upper airway (ex: nasal polyps, obstruction, recent nasal surgery, structural abnormality, rhinitis medicamentosa, etc.) that, in the opinion of the Investigator, could interfere with administration of the product, evaluation of the subject's condition, or other aspect of the trial.
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 | Drug | Test product |
| Nasonex Nasal Spray | Drug | Reference product |
| Placebo nasal spray | Drug | Placebo Nasal Spray |
Primary outcome
Mean Change from Baseline for mean reflective Total Nasal Symptom Score (rTNSS)
Time frame: 2 week treatment period
1 secondary outcome
Mean Change from Baseline in the mean Instantaneous Total Nasal Symptom Score (iTNSS)
Time frame: 2 weeks treatment period
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 22 Oct 2021.
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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.
1 site 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 and Nasonex Nasal Spray in people with Seasonal Allergic Rhinitis, run by Padagis LLC at 1 site 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 5 inclusion and 36 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 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Mean Change from Baseline for mean reflective Total Nasal Symptom Score (rTNSS) (time frame: 2 week treatment period). 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 22 Oct 2021.