Seasonal Allergic RhinitisPhase 1/2NCT01523236
Clinical Equivalence Study of Mometasone Nasal Spray, 50 Mcg/Actuation
A Phase 1/2 study testing Mometasone furoate and Nasonex® in people with Seasonal Allergic Rhinitis, run by Teva Pharmaceuticals USA.
Trial summary
The objective of this study is to evaluate the clinical equivalence of the test formulation of mometasone furoate anhydrous 50 mcg/actuation nasal spray (manufactured by Teva Pharmaceutical Industries, Ltd. 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 and Nasonex®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Jan 2012
- Phase
- Phase 1/2
- 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
- Male or non-pregnant, non-lactating female 12 years or age or older.
- Signed informed consent form, which meets all criteria of current FDA regulations. For patients under the age of majority in the state the study is being conducted (18 years in most states) the parent or legal guardian should sign the consent form and the child will be required to sign a patient "assent" form that will be written in such a way as to be understandable to a child.
- 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. In order for hormonal birth control to be considered a reliable method the patient must have been on their regimen for at least 28 days.
- 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 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. The patient must meet these minimum requirements prior to being entered into the placebo lead-in period and also prior to being enrolled in the randomized, active treatment period of the study.
Who cannot join
- Under 12 years of age.
- 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. The results of all positive skin allergen test results should be reported.
- 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.
- Patients who suffer only from perennial allergic rhinitis of seasonal allergic rhinitis to a different allergen than that in season at the time the study in conducted.
- Previous history of less that 2 years of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
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- A total score of less than 6 on the reflective Total Nasal Symptom Score (rTNSS) or a score less than 2 for "nasal congestion" or a score less than 2 for all 3 remaining symptoms. 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.
- 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 (e.g. significantly deformed septum, nasal polyps or ulcers) or any recent nasal surgery or trauma that has not completely healed.
- Sinus infection within the previous 30 days or history of re-occurring sinus infections.
- Patient has started immunotherapy (including topical or desensitization therapy) 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, or 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. Super or high potency topical steroids should not be used during the study. The use of low potency topical corticosteroids will be allowed. The use of hormonal contraceptives or hormone replacement therapy is allowed, on the condition that the patient has been on a stable dosing regime for at least 28 days prior to the start of the study and remains on the same dosing regimen during the study.
- Use of intranasal or systemic second-generation anti-histamines within 10 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 30 previous days and who cannot remain on the same dosing regime throughout the study.
- Desensitization therapy to the seasonal allergen that is causing the patient's 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 of 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 has a history or non-compliance with medication regiments or treatment protocols in previous clinical studies.
- The patient is a member of the investigational study staff or a member of the family of the investigational study staff.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Mometasone Furoate Anhydrous, 50 Mcg/Actuation Nasal Spray (Teva Pharmaceuticals USA) Compared to Nasonex® (Mometasone Furoate Monohydrate) 50 Mcg/Actuation Nasal Spray (Schering) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
The objective of this study is to evaluate the clinical equivalence of the test formulation of mometasone furoate anhydrous 50 mcg/actuation nasal spray (manufactured by Teva Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) to the marketed formulation Nasonex® (mometasone furoate monohydrate) nasal spray, 50 mcg/actuation (Schering) in patients with seasonal allergic rhinitis.
In addition, the efficacy of both the test and reference nasal sprays will be compared to a placebo nasal spray and safety will be compared.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Mometasone furoate, Nasonex®, Placebo
- Keywords
- Allergic Rhinitis, Bioequivalence
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone furoateDrug
50 mcg/actuation Nasal Spray
Nasonex®Drug
Also called Mometasone furoate (generic name)
50 mcg/actuation Nasal Spray
PlaceboDrug
Nasal Spray
| Study group | Role | What they receive |
|---|---|---|
| Investigational Test Product | Experimental | Mometasone furoate anhydrous 50 mcg/actuation Nasal Spray (Teva) Receives: Drug: Mometasone furoate |
| Reference Listed Drug | Active comparator | Nasonex® (mometasone furoate monohydrate) 50 mcg/actuation Nasal Spray (Schering) Receives: Drug: Nasonex® |
| Placebo | Placebo comparator | Saline Placebo Nasal Spray Receives: Drug: Placebo |
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)
The statistical analysis for both clinical equivalence and superiority of the active treatments over placebo will involve Analysis of Covariance (ANCOVA).
The Per-Protocol Population (PPP) will be used for the primary analysis of bioequivalence.
The Intent-to-Treat Population (ITT) will be used for the primary analysis of superiority.
Measured: 2 week treatment period
Secondary outcomes (1)
Mean Change from Baseline in the mean Instantaneous Total Nasal Symptom Score (iTNSS)
Mean values will be presented for the secondary efficacy variable. Statistical analysis will be performed by ANCOVA.
Measured: 2 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionJan 2012
- Study completionJan 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 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523236
- Sponsor's protocol ID
- 70936005
- Status last verified
- Jan 2012
- First submitted
- 27 Jan 2012
- Last updated
- 1 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Mometasone Furoate Anhydrous, 50 Mcg/Actuation Nasal Spray (Teva Pharmaceuticals USA) Compared to Nasonex® (Mometasone Furoate Monohydrate) 50 Mcg/Actuation Nasal Spray (Schering) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01523236
- Acronym / sponsor ID
- 70936005
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Allergic Rhinitis, Bioequivalence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 1 Feb 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 objective of this study is to evaluate the clinical equivalence of the test formulation of mometasone furoate anhydrous 50 mcg/actuation nasal spray (manufactured by Teva Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) to the marketed formulation Nasonex® (mometasone furoate monohydrate) nasal spray, 50 mcg/actuation (Schering) in patients with seasonal allergic rhinitis.
In addition, the efficacy of both the test and reference nasal sprays will be compared to a placebo nasal spray and safety will be compared.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational Test Product | Experimental | Drug: Mometasone furoateMometasone furoate anhydrous 50 mcg/actuation Nasal Spray (Teva) |
| Reference Listed Drug | Active comparator | Drug: Nasonex®Nasonex® (mometasone furoate monohydrate) 50 mcg/actuation Nasal Spray (Schering) |
| Placebo | Placebo comparator | Drug: PlaceboSaline Placebo Nasal Spray |
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)
- Male or non-pregnant, non-lactating female 12 years or age or older.
- Signed informed consent form, which meets all criteria of current FDA regulations. For patients under the age of majority in the state the study is being conducted (18 years in most states) the parent or legal guardian should sign the consent form and the child will be required to sign a patient "assent" form that will be written in such a way as to be understandable to a child.
- 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. In order for hormonal birth control to be considered a reliable method the patient must have been on their regimen for at least 28 days.
- 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 years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
Key exclusion criteria (33 listed)
- Under 12 years of age.
- 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. The results of all positive skin allergen test results should be reported.
- 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.
- Patients who suffer only from perennial allergic rhinitis of seasonal allergic rhinitis to a different allergen than that in season at the time the study in 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 furoate50 mcg/actuation Nasal Spray | Drug | Investigational Test Product |
| Nasonex®Also: Mometasone furoate (generic name)50 mcg/actuation Nasal Spray | Drug | Reference Listed Drug |
| PlaceboNasal Spray | Drug | Placebo |
Primary outcome
Mean Change from Baseline for mean reflective Total Nasal Symptom Score (rTNSS)
Time frame: 2 week treatment period
The statistical analysis for both clinical equivalence and superiority of the active treatments over placebo will involve Analysis of Covariance (ANCOVA). The Per-Protocol Population (PPP) will be used for the primary analysis of bioequivalence. The Intent-to-Treat Population (ITT) will be used for the primary analysis of superiority.
1 secondary outcome
Mean Change from Baseline in the mean Instantaneous Total Nasal Symptom Score (iTNSS)
Time frame: 2 week 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 1 Feb 2012.
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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 1/2 study testing Mometasone furoate and Nasonex® in people with Seasonal Allergic Rhinitis, run by Teva Pharmaceuticals USA.
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 1 Feb 2012. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 1 Feb 2012.