Seasonal Allergic RhinitisPhase 3NCT02249663
Clinical Equivalence of Azelastine Hydrochloride and Fluticasone Propionate, 137/50 mcg Nasal Spray to Dymista™
A Phase 3 study testing Azelastine hydrochloride and Fluticasone propionate and Dymista™ in people with Seasonal Allergic Rhinitis, run by Teva Pharmaceuticals USA at 1 site in United States.
Trial summary
To evaluate the therapeutic equivalence of a test formulation of Azelastine hydrochloride and Fluticasone propionate Nasal Spray to the reference listed drug, Dymista™ Nasal Spray in the relief of the signs and symptoms of 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?
- Azelastine hydrochloride and Fluticasone propionate and Dymista™
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,535 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Feb 2015
- 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
- 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 to be understandable to a child.
- 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 (SAR) to the pollen/allergen in season at the time the study is being conducted.
- Eligibility requirements for placebo lead-in period: A total (composite) score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) with a minimum of at least 2 for "nasal congestion" and a minimum score of at least 2 for one of the remaining 3 symptoms and total (composite) score of at least 4 on the reflective Total Ocular Symptom Score (rTOSS). These scores represent the 12 hours before the screening visit.
- In addition to requirements above, patients should have the following at the end of the placebo lead-in period and before randomization: 1) average composite score of at least 6 on the rTNSS with a minimum average score of at least 2 for "nasal congestion" and a minimum average score of at least 2 for one of the remaining 3 symptoms, and 2) average composite score of at least 4 on the rTOSS. These scores represent the 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.
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 the chronic PAR.
- Patients who suffer only from PAR or SAR to a different allergen than that in season at the time the study is conducted.
- Previous history of less than 2 years of SAR to the pollen/allergen in season at the time the study is conducted.
Show all 36Show fewer
- Before the placebo lead-in period, the patient has a total score of less than 6 on the rTNSS or a score less than 2 for "nasal congestion". Any patient who meets the minimum individual nasal symptom score 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.
- At the end of the placebo lead-in period and before randomization, the patient has an average composite score of less than 6 on the rTNSS and an average composite score of less than 4 on the rTOSS.
- History of asthma over the previous 2 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 or re-occurring 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 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.
- Use of medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4.
- Use of intranasal or systemic second-generation anti-histamines within 10 days or enrollment.
- Use of intranasal cromolyn within 14 days of enrollment.
- Use of intranasal or systemic first-generation anti-histamines, leukotriene receptor antagonsits 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 regimen for at least the 30 previous days and who cannot remain of the same dose 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 azelastine hydrochloride, fluticasone propionate, other steroids, or any 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 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Novum Pharmaceutical Research Services
Pittsburgh, Pennsylvania, 15206
Gail Gongas, 412-363-3300
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Site Study to Evaluate the Therapeutic Equivalence of Azelastine Hydrochloride and Fluticasone Propionate, 137/50 mcg Nasal Spray, to Dymista™ Nasal Spray
To evaluate the therapeutic equivalence of a test formulation of Azelastine hydrochloride and Fluticasone propionate Nasal Spray to the reference listed drug, Dymista™ Nasal Spray in the relief of the signs and symptoms of Seasonal Allergic Rhinitis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Azelastine hydrochloride and Fluticasone propionate, Dymista™, Placebo
- Keywords
- Bioequivalence
- 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.
Azelastine hydrochloride and Fluticasone propionateDrug
137/50 mcg Nasal Spray
Dymista™Drug
Also called Azelastine hydrochloride and Fluticasone propionate (generic name)
137/50 mcg Nasal Spray
PlaceboOther
Nasal spray with no pharmaceutically active content
| Study group | Role | What they receive |
|---|---|---|
| Investigational Test Product | Experimental | Azelastine hydrochloride and Fluticasone propionate Nasal Spray, 137/50 mcg Receives: Drug: Azelastine hydrochloride and Fluticasone propionate |
| Reference Listed Drug | Active comparator | Dymista™ (azelastine hydrochloride/fluticasone propionate) Nasal Spray, 137/50 mcg Receives: Drug: Dymista™ |
| Placebo | Placebo comparator | Placebo Nasal Spray Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS).
Measured: Days 1 to 14
Secondary outcomes (4)
Change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS).
Measured: Days 1 to 14
Change from baseline in average reflective Total Ocular Symptom Score (iTOSS).
Measured: Days 1 to 14
Change from baseline in average instantaneous Total Ocular Symptom Score (iTOSS).
Measured: Days 1 to 14
Onset of Action
Measured: 4 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2015 (estimated)
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,535 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darin Brimhall, DO, FACP, Principal investigator, Novum Pharmaceutical Research Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249663
- Sponsor's protocol ID
- 71336006
- Status last verified
- Sep 2014
- First submitted
- 18 Sep 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. 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 Evaluate the Therapeutic Equivalence of Azelastine Hydrochloride and Fluticasone Propionate, 137/50 mcg Nasal Spray, to Dymista™ Nasal Spray
- ClinicalTrials.gov ID
- NCT02249663
- Acronym / sponsor ID
- 71336006
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Bioequivalence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,535 participants (estimated)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (estimated)
- First posted
- 25 Sep 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 a test formulation of Azelastine hydrochloride and Fluticasone propionate Nasal Spray to the reference listed drug, Dymista™ Nasal Spray in the relief of the signs and symptoms of Seasonal Allergic Rhinitis.
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: Azelastine hydrochloride and Fluticasone propionateAzelastine hydrochloride and Fluticasone propionate Nasal Spray, 137/50 mcg |
| Reference Listed Drug | Active comparator | Drug: Dymista™Dymista™ (azelastine hydrochloride/fluticasone propionate) Nasal Spray, 137/50 mcg |
| Placebo | Placebo comparator | Other: PlaceboPlacebo 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 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 to be understandable to a child.
- 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 (SAR) to the pollen/allergen in season at the time the study is being conducted.
- Eligibility requirements for placebo lead-in period: A total (composite) score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) with a minimum of at least 2 for "nasal congestion" and a minimum score of at least 2 for one of the remaining 3 symptoms and total (composite) score of at least 4 on the reflective Total Ocular Symptom Score (rTOSS). These scores represent the 12 hours before the screening visit.
Key exclusion criteria (36 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 the chronic PAR.
- Patients who suffer only from PAR or SAR to a different allergen than that in season at the time the study is 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 |
|---|---|---|
| Azelastine hydrochloride and Fluticasone propionate137/50 mcg Nasal Spray | Drug | Investigational Test Product |
| Dymista™Also: Azelastine hydrochloride and Fluticasone propionate (generic name)137/50 mcg Nasal Spray | Drug | Reference Listed Drug |
| PlaceboNasal spray with no pharmaceutically active content | Other | Placebo |
Primary outcome
Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS).
Time frame: Days 1 to 14
4 secondary outcomes
Change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS).
Time frame: Days 1 to 14
Change from baseline in average reflective Total Ocular Symptom Score (iTOSS).
Time frame: Days 1 to 14
Change from baseline in average instantaneous Total Ocular Symptom Score (iTOSS).
Time frame: Days 1 to 14
Onset of Action
Time frame: 4 hours post dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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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.
Darin Brimhall, DO, FACP principal investigator
Novum Pharmaceutical Research Services
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 Azelastine hydrochloride and Fluticasone propionate and Dymista™ in people with Seasonal Allergic Rhinitis, run by Teva Pharmaceuticals USA 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 6 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: status not confirmed, as of the sponsor's last update on 25 Sep 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Darin Brimhall, DO, FACP ((702) 435-3739 ext. 370, dbrimhall@novumprs.som), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS). (time frame: Days 1 to 14). 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 25 Sep 2014.