Seasonal Allergic Rhinitis
Conditions
Brief summary
A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Mometasone Nasal Spray (Watson Laboratories, Inc) with NASONEX® Nasal Spray (Schering Corporation) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
Interventions
Sponsors
Watson Laboratories, Inc.
Actavis Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant non-lactating female * 12 years of 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 (e.g., condom with spermicide, IUD, oral, injected, transdermal or implanted hormonal contraceptives). 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 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 (see Appendix A) representing the 12 hours prior to the screening visit. * An average composite 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 (see Appendix A) representing the last 3 days of the 7-day placebo run-in period before the randomization visit and the morning of the first day of the randomization visit.
Exclusion criteria
* 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 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. * 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 of the remaining symptoms (see Appendix A). 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, 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 (e.g. OTC 1% hydrocortisone) will be allowed. The use of hormonal contraceptives or hormone replacement therapy is allowed, on condition the patient has been on a stable dosing regimen 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 (e.g. fexofenadine, loratadine, desloratadine, cetirizine) 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 (montelukast) 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 has a history of non-compliance with medication regimens 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. * The patient currently smokes cigarettes, cigars, and/or pipes and is a heavy smoker (for example, on average more than 10 cigarettes per day).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average AM/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14. | Twice daily from Baseline to 2 weeks | The Total Nasal Symptom Score Scale was used. Patients rated each of the following four symptoms on a scale from 0 to 3 : Nasal Congestion, Runny Nose, Sneezing, and Itchy Nose. Measurements were taken twice daily approximately 12 hours apart. 0= No symptom 1. Mild symptoms (sign/symptom present, minimal awareness, easily tolerated) 2. Moderate symptom (definite awareness of sign/symptom, bothersome but tolerable) 3. Severe symptom (sign/symptom hard to tolerate, causes interference with daily activities and/or sleeping) |
| Superiority of Active Treatment Arms Over Placebo | Twice daily from Baseline to 2 weeks | Superiority analysis of Change From Baseline in rTNSS for both active arms compared to placebo arm. The Total Nasal Symptom Score Scale was used. Patients rated each of the following four symptoms on a scale from 0 to 3: Nasal Congestion, Runny Nose, Sneezing, and Itchy Nose twice daily approximately 12 hours apart. 0= No symptom 1. Mild symptoms (sign/symptom present, minimal awareness, easily tolerated) 2. Moderate symptom (definite awareness of sign/symptom, bothersome but tolerable) 3. Severe symptom (sign/symptom hard to tolerate, causes interference with daily activities and/or sleeping) |
Countries
United States
Participant flow
Recruitment details
Randomized subjects in active treatment.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo vehicle nasal spray (no active ingredients) Dose = 4 total actuations in alternating nostrils | 175 |
| NASONEX® Nasal Spray (Schering Corporation) Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg) | 350 |
| Mometasone Nasal Spray (Watson Laboratories, Inc) Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg) | 355 |
| Total | 880 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Early Visit Window | 0 | 1 | 4 |
| Overall Study | Enrolled in Error | 0 | 1 | 2 |
| Overall Study | Lack of Efficacy | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Restricted Medication | 0 | 0 | 2 |
| Overall Study | Significant worstening of SAR | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | NASONEX® Nasal Spray (Schering Corporation) | Mometasone Nasal Spray (Watson Laboratories, Inc) | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 38.70 years STANDARD_DEVIATION 14.45 | 38.80 years STANDARD_DEVIATION 14.18 | 39.31 years STANDARD_DEVIATION 14.45 | 39.00 years STANDARD_DEVIATION 14.36 |
| Primary Allergen Grass | 2 Participants | 5 Participants | 1 Participants | 8 Participants |
| Primary Allergen Multi-Allergen | 114 Participants | 119 Participants | 64 Participants | 297 Participants |
| Primary Allergen Tree | 234 Participants | 231 Participants | 110 Participants | 575 Participants |
| Race/Ethnicity, Customized Asian | 11 Participants | 9 Participants | 5 Participants | 25 Participants |
| Race/Ethnicity, Customized Black/African American | 75 Participants | 68 Participants | 45 Participants | 188 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 259 Participants | 276 Participants | 123 Participants | 658 Participants |
| Sex: Female, Male Female | 243 Participants | 216 Participants | 126 Participants | 585 Participants |
| Sex: Female, Male Male | 107 Participants | 139 Participants | 49 Participants | 295 Participants |
| Tobacco Use Have not use tobacco | 336 Participants | 342 Participants | 168 Participants | 846 Participants |
| Tobacco Use Have used tobacco | 14 Participants | 13 Participants | 7 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 175 | 0 / 350 | 0 / 355 |
| other Total, other adverse events | 20 / 175 | 23 / 350 | 18 / 355 |
| serious Total, serious adverse events | 0 / 175 | 0 / 350 | 0 / 355 |
Outcome results
Primary
Change From Baseline in Average AM/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14.
The Total Nasal Symptom Score Scale was used. Patients rated each of the following four symptoms on a scale from 0 to 3 : Nasal Congestion, Runny Nose, Sneezing, and Itchy Nose. Measurements were taken twice daily approximately 12 hours apart. 0= No symptom 1. Mild symptoms (sign/symptom present, minimal awareness, easily tolerated) 2. Moderate symptom (definite awareness of sign/symptom, bothersome but tolerable) 3. Severe symptom (sign/symptom hard to tolerate, causes interference with daily activities and/or sleeping)
Time frame: Twice daily from Baseline to 2 weeks
Population: Per Protocol Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NASONEX® Nasal Spray (Schering Corporation) | Change From Baseline in Average AM/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14. | 1.861 score on a scale | Standard Deviation 2.186 |
| Mometasone Nasal Spray (Watson Laboratories, Inc) | Change From Baseline in Average AM/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14. | 1.600 score on a scale | Standard Deviation 2.223 |
Comparison: Conducted on Per Protocol Population90% CI: [99.077, 134.286]
Primary
Superiority of Active Treatment Arms Over Placebo
Superiority analysis of Change From Baseline in rTNSS for both active arms compared to placebo arm. The Total Nasal Symptom Score Scale was used. Patients rated each of the following four symptoms on a scale from 0 to 3: Nasal Congestion, Runny Nose, Sneezing, and Itchy Nose twice daily approximately 12 hours apart. 0= No symptom 1. Mild symptoms (sign/symptom present, minimal awareness, easily tolerated) 2. Moderate symptom (definite awareness of sign/symptom, bothersome but tolerable) 3. Severe symptom (sign/symptom hard to tolerate, causes interference with daily activities and/or sleeping)
Time frame: Twice daily from Baseline to 2 weeks
Population: Intent to treat.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NASONEX® Nasal Spray (Schering Corporation) | Superiority of Active Treatment Arms Over Placebo | 0.898 score on a scale | Standard Deviation 1.762 |
| Mometasone Nasal Spray (Watson Laboratories, Inc) | Superiority of Active Treatment Arms Over Placebo | 1.609 score on a scale | Standard Deviation 2.225 |
| Mometasone Nasal Spray (Watson Laboratories, Inc) | Superiority of Active Treatment Arms Over Placebo | 1.863 score on a scale | Standard Deviation 2.191 |
Comparison: The superiority of treatment over the placebo will be concluded if the treatment's mean change from baseline is statistically significantly greater (p\<0.05, 2-sided) than that of the placebo in the ANCOVA based on the treatment and placebo results. The superiority of Test and Reference treatments over the placebo will be evaluated identically in a separate ANCOVA.p-value: <0.0001ANCOVA
Comparison: The superiority of treatment over the placebo will be concluded if the treatment's mean change from baseline is statistically significantly greater (p\<0.05, 2-sided) than that of the placebo in the ANCOVA based on the treatment and placebo results. The superiority of Test and Reference treatments over the placebo will be evaluated identically in a separate ANCOVA.p-value: 0.0002ANCOVA