Your session is about to expire
← Back to Search
Azelastine + Fluticasone Nasal Spray for Hay Fever
Phase 3
Waitlist Available
Led By Darin Brimhall, DO, FACP
Research Sponsored by Teva Pharmaceuticals USA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1 to 14
Awards & highlights
Study Summary
This trial is testing whether a new nasal spray is as effective as the current standard in treating seasonal allergies.
Who is the study for?
This trial is for individuals aged 12 or older with a documented positive skin test to seasonal allergens and at least two years of history with Seasonal Allergic Rhinitis. They must have specific minimum symptom scores for nasal congestion and ocular issues. Excluded are pregnant women, those on certain medications, patients with recent infections or surgeries, heavy smokers, and anyone with chronic conditions that could interfere.Check my eligibility
What is being tested?
The study aims to compare the effectiveness of a new combination nasal spray (Azelastine hydrochloride and Fluticasone propionate) against Dymista™ in treating symptoms of Seasonal Allergic Rhinitis. Participants will also be compared to a placebo group to measure the treatment's impact on nasal congestion and related symptoms.See study design
What are the potential side effects?
Potential side effects may include local irritation in the nose, headache, nosebleeds, taste disturbances or unpleasant taste sensation after use (dysgeusia), drowsiness or fatigue. More serious but less common side effects might involve changes in vision or increased intraocular pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe nasal and eye symptoms, scoring at least 6 for nose issues and 4 for eye issues.
Select...
My allergy symptoms score is high enough to qualify after a test period.
Select...
I am a male or a female not pregnant or breastfeeding, aged 12 or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1 to 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1 to 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS).
Secondary outcome measures
Change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS).
Change from baseline in average instantaneous Total Ocular Symptom Score (iTOSS).
Change from baseline in average reflective Total Ocular Symptom Score (iTOSS).
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Investigational Test ProductExperimental Treatment1 Intervention
Azelastine hydrochloride and Fluticasone propionate Nasal Spray, 137/50 mcg
Group II: Reference Listed DrugActive Control1 Intervention
Dymista™ (azelastine hydrochloride/fluticasone propionate) Nasal Spray, 137/50 mcg
Group III: PlaceboPlacebo Group1 Intervention
Placebo Nasal Spray
Find a Location
Who is running the clinical trial?
Teva Pharmaceuticals USALead Sponsor
230 Previous Clinical Trials
186,665 Total Patients Enrolled
Darin Brimhall, DO, FACPPrincipal InvestigatorNovum Pharmaceutical Research Services
1 Previous Clinical Trials
48 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have not had allergies to pollen or other allergens for at least 2 years before the study starts.I am younger than 12 years old.I have seasonal allergies, not year-round allergies.You are allergic to azelastine hydrochloride, fluticasone propionate, or any ingredients in the nasal spray being studied.I have undergone therapy to reduce my allergy symptoms in the last 6 months.I (or my guardian if I'm under 18) have signed the informed consent form.I have a significant nasal shape issue or recent, unhealed nasal surgery or injury.I haven't used any first-gen anti-histamines or nasal decongestants in the last 3 days.I have had a sinus infection in the last 30 days or often get them.My nasal symptoms are mild before starting the placebo phase.You have had a positive allergy skin test to the allergens that are in season during the study.I have had seasonal allergies for at least two years.I started or changed my immunotherapy dose within the last 30 days or might need to during the study.I have severe nasal and eye symptoms, scoring at least 6 for nose issues and 4 for eye issues.My allergy symptoms score is high enough to qualify after a test period.I am not pregnant, breastfeeding, or planning to become pregnant during the study.I have not used intranasal cromolyn in the last 14 days.I have been exposed to chicken pox or measles in the last 30 days.I have ADHD and haven't been on a stable dose of medication for the last 30 days.I haven't taken any tricyclic antidepressants in the last 30 days.I am a heavy smoker, smoking more than 10 cigarettes a day.I haven't had serious infections like fungal, bacterial, or viral in the last month.You have not had an allergy test for common seasonal allergens in the past year, or the results of your allergy test were negative. If you had a positive allergy test, those results should be reported.I will not travel outside my local area for more than 2 days in a row or 3 days in total during the study.I have had asthma needing regular treatment in the last 2 years, but only use beta-agonists for sudden attacks.I have a nasal condition such as a chronic nose infection or medication-induced nasal issue.I haven't used eye steroids in 14 days or any steroids in 30 days.My average scores for nasal and eye symptoms are below 6 and 4 respectively.I haven't used any second-generation anti-histamines in the last 10 days.My allergies or asthma did not improve with steroid treatment.You have allergies to different things than what is in season during the study.I have been treated for oral yeast infection within the last month or have it now.I have had tuberculosis in the past.I am a male or a female not pregnant or breastfeeding, aged 12 or older.I am taking medication that affects the CYP3A4 enzyme.I have not had a cold or similar infection in the last month.I don't have eye conditions like glaucoma or infections unrelated to SAR within the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Reference Listed Drug
- Group 3: Investigational Test Product
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared Azelastine hydrochloride and Fluticasone propionate for use?
"Azelastine hydrochloride and Fluticasone propionate's safety is estimated to be a 3. This is due to the fact that it is a phase 3 trial, and thus there is some data to support efficacy as well as safety."
Answered by AI
What medical condition do Azelastine hydrochloride and Fluticasone propionate help alleviate?
"The usual course of treatment for blepharitis allergic is through the use of Azelastine hydrochloride and Fluticasone propionate. This combination of drugs is also effective in managing vasomotor rhinitis, rhinorrhoea, and seasonal allergic rhinitis."
Answered by AI
What is the efficacy of Azelastine hydrochloride and Fluticasone propionate in other medical trials?
"11 clinical trials testing Azelastine hydrochloride and Fluticasone propionate are ongoing, 3 of which are in Phase 3. Most of the research surrounding this treatment is based in London and Colorado, though there are also trials taking place in 13 other locations."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger