Seasonal Allergic RhinitisPhase 3NCT02230696
Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis
A Phase 3 study testing Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray in people with Seasonal Allergic Rhinitis, run by Padagis LLC at 30 sites in United States.
Trial summary
To compare safety and efficacy of Perrigo's steroid drug product compared with an FDA approved steroid drug product in the treatment of subjects with 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?
- Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 951 participants
- Where
- 30 sitesUnited States
- Study dates
- Aug 2014to Feb 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years of age, inclusive.
- Females of childbearing potential willing to use an acceptable form of birth control during the study.
- Moderate-to-severe allergic rhinitis.
- At Visits 1 and 2 have instantaneous and reflective symptom scores sufficient enough to qualify for continued participation in the study
- Subject must have a history (for 2 or more seasons) of seasonal allergy to at least one allergen known to be present during the study season.
- Subject must be in general good health with no clinically significant disease or medical procedure other than allergic rhinitis within various time periods prior to Visit 1.
- Subject must be willing and able to understand and comply with the requirements of the study
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 any ingredient in the drug products.
- Subject has any condition or abnormality of the upper airway 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.
- The presence of any nasal mucosal crusting, erosion, ulceration, nasal septum perforation, or any kind of blockage of the nasal passages at screening or randomization.
- Subject has asthma or a history of asthma requiring chronic treatment within two years of Visit 1.
- Treatment for oral Candidiasis within 30 days of starting the study, or a current oral Candidiasis infection.
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- Subject has had recent exposure (30 days) or is at risk of being exposed to chicken pox or measles.
- Subjects with any untreated fungal, bacterial, systemic viral infections within the previous 30 days.
- Use of various therapies within the given time period prior to Visit 1 and throughout the study.
- Initiation of hormone replacement therapy during the study.
- Initiation of immunotherapy during the study, or changes in dosage or frequency of immunotherapy within the 30 days preceding Visit 1.
- Subject has received immune-system therapy or peptide immunotherapy of any form.
- 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.
- Clinically relevant abnormal physical findings or medication use within 1 week of randomization, 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.
- Subjects being treated with a product containing a sympathomimetic agent.
- Subject has previously enrolled in this study or is enrolled in this study with another participating investigator site.
- Subject is concurrently participating in another investigational study or using any investigational drug (or biologic) or device.
- Subject plans or anticipates travel outside the local allergen area at any point in the study.
- History of unresponsiveness to steroid nasal sprays for SAR symptoms.
- Employee (or employee's family member) of the research center or private practice.
- If the subject has a smoking history of greater than 10 pack years or has recently started or re-started smoking within the past 2 years
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
ISIS Clinical Research, LLC
Austin, Texas, 78731
Sirius Clinical Research LLC
Austin, Texas, 78759
Chesapeake Clinical Research, Inc.
Baltimore, Maryland, 21236
The Asthma & Allergy Center - Bellevue
Bellevue, Washington, 68123
Clinical Research of the Ozarks, Inc.
Columbia, Missouri, 65203
AARA Research Center
Dallas, Texas, 75231
Pharmaceutical Research & Consulting Inc.
Dallas, Texas, 75231
Western Sky Medical Research
El Paso, Texas, 79904
Allergy and Asthma Center of NC
High Point, North Carolina, 27262
New Phase Research and Development
Knoxville, Tennessee, 37919
Family Allergy and Asthma Research Institute
Louisville, Kentucky, 40215
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402
Clinical Research Institute LLC
Minneapolis, Minnesota, 63141
Central Texas Health Research
New Braunfels, Texas, 78130
National Allergy, Asthma & Urticaria Centers of Charleston
North Charleston, South Carolina, 29420
NEMRA Northeast Medical Research Associates, Inc
North Dartmouth, Massachusetts, 02747
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Island Medical Research, P.C.
Rockville Centre, New York, 11570
Clinical Research of the Ozarks, Inc.
Rolla, Missouri, 65401
Quality Research Inc.
San Antonio, Texas, 78209
Diagnostics Research Group
San Antonio, Texas, 78229
Sylvana Research Associates
San Antonio, Texas, 78257
Princeton Center for Clinical Research
Skillman, New Jersey, 08558
The Clinical Research Center, LLC
St Louis, Missouri, 63141
Atlanta Allergy & Asthma Clinic, PA
Stockbridge, Georgia, 30281
Clinical Research Atlanta (CRA)
Stockbridge, Georgia, 30281
Toledo Center for Clinical Research
Sylvania, Ohio, 43560
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136
Allergy Asthma Research Institute
Waco, Texas, 76712
About this study
To compare safety and efficacy of Perrigo's steroid drug product compared with an FDA approved steroid drug product in the treatment of subjects with seasonal allergic rhinitis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Azelastine Hydrochloride/Fluticasone Propionate 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.
Azelastine Hydrochloride/Fluticasone Propionate Nasal SprayDrug
Also called Perrigo Product
137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate
Azelastine Hydrochloride/Fluticasone Propionate Nasal SprayDrug
Also called Reference Listed Drug Product
137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate
Placebo nasal sprayDrug
Placebo nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo Receives: Drug: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray |
| Reference Product | Active comparator | Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Meda Receives: Drug: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray |
| Placebo Product | Placebo comparator | Placebo nasal spray 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)
The symptoms included in the reflective Total Nasal Symptom Score (rTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.
Measured: Day 1 through Day 14
Secondary outcomes (2)
Mean Change From Baseline in the Mean Instantaneous Total Nasal Symptom Score (iTNSS)
The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.
Measured: Day 1 through Day 14
Change From Baseline iTNSS Scores on Day 1 Post First Randomized Dose
This outcome measured the time to statistical significance of the reduction of signs/symptoms over a 4 hour period on Day 1 only by measuring the reduction in iTNSS scores. When the change from baseline was statistically significant, it was associated with a time to onset of the anti-histamine component of the formulation.
Subjects will record iTNSS scores for 4 hours post first randomized dose. The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.
Measured: Day 1, up to four hours post the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 951 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
- NCT02230696
- Sponsor's protocol ID
- PRG-NY-14-018
- Status last verified
- Oct 2021
- First submitted
- 29 Aug 2014
- Last updated
- 22 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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
- Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02230696
- Acronym / sponsor ID
- PRG-NY-14-018
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 951 participants (actual)
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Posted 15 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare safety and efficacy of Perrigo's steroid drug product compared with an FDA approved steroid drug product in the treatment of subjects with seasonal allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: Azelastine Hydrochloride/Fluticasone Propionate Nasal SprayAzelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo |
| Reference Product | Active comparator | Drug: Azelastine Hydrochloride/Fluticasone Propionate Nasal SprayAzelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Meda |
| Placebo Product | Placebo comparator | Drug: Placebo nasal sprayPlacebo nasal spray |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Complete the informed consent/assent process.
- Male or female between 12 to 65 years of age, inclusive.
- Females of childbearing potential willing to use an acceptable form of birth control during the study.
- Moderate-to-severe allergic rhinitis.
- At Visits 1 and 2 have instantaneous and reflective symptom scores sufficient enough to qualify for continued participation in the study
Key exclusion criteria (22 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 any ingredient in the drug products.
- Subject has any condition or abnormality of the upper airway 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.
- The presence of any nasal mucosal crusting, erosion, ulceration, nasal septum perforation, or any kind of blockage of the nasal passages at screening or randomization.
- Subject has asthma or a history of asthma requiring chronic treatment within two years of Visit 1.
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/Fluticasone Propionate Nasal SprayAlso: Perrigo Product137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate | Drug | Test Product |
| Azelastine Hydrochloride/Fluticasone Propionate Nasal SprayAlso: Reference Listed Drug Product137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate | Drug | Reference Product |
| Placebo nasal sprayPlacebo nasal spray | Drug | Placebo Product |
Primary outcome
Mean Change From Baseline for Mean Reflective Total Nasal Symptom Score (rTNSS)
Time frame: Day 1 through Day 14
The symptoms included in the reflective Total Nasal Symptom Score (rTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.
2 secondary outcomes
Mean Change From Baseline in the Mean Instantaneous Total Nasal Symptom Score (iTNSS)
Time frame: Day 1 through Day 14
Change From Baseline iTNSS Scores on Day 1 Post First Randomized Dose
Time frame: Day 1, up to four hours post the first dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
30 sites 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/Fluticasone Propionate Nasal Spray in people with Seasonal Allergic Rhinitis, run by Padagis LLC at 30 sites 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 8 inclusion and 22 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 30 sites 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?
Yes. Results are posted in the registry (first posted 15 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Day 1 through Day 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 22 Oct 2021.