Seasonal Allergic RhinitisPhase 3NCT02246920
Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients
A Phase 3 study testing Fluticasone propionate and Flonase® in people with Seasonal Allergic Rhinitis, run by Teva Pharmaceuticals USA at 1 site in United States.
Trial summary
This double-blind, randomized, placebo-controlled, parallel group, multi-site study has been designed to compare the safety and efficacy of a generic Fluticasone propionate Nasal Spray, 50 mcg (Teva Pharmaceuticals USA) to the FDA Reference Listed Drug, Flonase® (fluticasone propionate) 50 mcg nasal spray… 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?
- Fluticasone propionate and Flonase®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,474 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2014to 14 Jul 2014
- 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 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 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 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 representing the last 3 days of the 7-day lead-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 of the study is being conducted. The results of all positive shin allergen tests 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 that 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.
Show all 35Show fewer
- A total score of less that 6 on the reflective Total Nasal Symptom Score (rTNSS) or a score of less than 2 for "nasal congestion" or a score of less than 2 for all 3 of the remaining symptoms.
- 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 (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-occuring sinus infections.
- Patient has started immunotherapy (including topical or desensitization therapy) or changed their dose of immunotherapy within 30 days of the first 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 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.
- Use of medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4.
- 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 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 fluticasone, other steroids, or any of the components of the study nasal sprays.
- 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 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 medical 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
Novum Pharmaceutical Research Services
Pittsburgh, Pennsylvania, 15206
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Nasal Spray, 50 mcg With Flonase® Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
This double-blind, randomized, placebo-controlled, parallel group, multi-site study has been designed to compare the safety and efficacy of a generic Fluticasone propionate Nasal Spray, 50 mcg (Teva Pharmaceuticals USA) to the FDA Reference Listed Drug, Flonase® (fluticasone propionate) 50 mcg nasal spray (GlaxoSmithKline), in the relief of the signs and symptoms of Seasonal Allergic Rhinitis. Additionally, both the test and reference formulations will be tested for superiority against a placebo nasal spray.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Fluticasone propionate, Flonase®, Placebo
- Keywords
- Bioequivalence, Allergic Rhinitis
- 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.
Fluticasone propionateDrug
50 mcg/actuation Nasal Spray
Flonase®Drug
Also called Fluticasone propionate (generic name)
50 mcg/actuation Nasal Spray
PlaceboDrug
Inactive Nasal Spray
| Study group | Role | What they receive |
|---|---|---|
| Investigational Test Product | Experimental | Fluticasone propionate Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days Receives: Drug: Fluticasone propionate |
| Reference Listed Drug | Active comparator | Flonase® (fluticasone propionate) Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days Receives: Drug: Flonase® |
| Placebo | Placebo comparator | Saline Placebo Nasal Spray; 4 total sprays/day for 14 days Receives: Drug: 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) Over Days 1 to 14.
Total Nasal Symptom Score (TNSS) is defined as the sum of the patient-rated nasal symptom severity scores for the following four allergy symptoms: Runny Nose, Nasal Congestion, Itchy Nose, and Sneezing. The severity score for each symptom will be based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The higher the score, the worse the symptoms of the 4 allergy categories are (runny nose, nasal congestions, itchy nose, and sneezing.
The primary analysis for determining the therapeutic equivalence of the Test and Reference treatments will be based on each treatment's mean change from baseline for average rTNSS over the 2 week randomization treatment period.
The Per-Protocol Population (PPP) will be used for the primary analysis of bioequivalence.
The Modified Intent to Treat Population (mITT) will be used for Superiority Analysis.
Measured: 2 week treatment period: Day 0-14
Secondary outcomes (1)
Change From Baseline in Average Instantaneous Total Nasal Symptom Score (iTNSS) Over Days 1 to 14.
Secondary efficacy analysis will evaluate the mean change from baseline in average iTNSS over the 2 week randomization treatment period.
The Per-Protocol Population (PPP) will be used for the analysis of bioequivalence.
Total Nasal Symptom Score (TNSS) is defined as the sum of the patient-rated nasal symptom severity scores for the following four allergy symptoms: Runny Nose, Nasal Congestion, Itchy Nose, and Sneezing. The severity score for each symptom will be based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The higher the score, the worse the symptoms of the 4 allergy categories are (runny nose, nasal congestions, itchy nose, and sneezing.
Measured: 2 week treatment period: Day 0 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study start1 Mar 2014
- Primary completion14 Jul 2014
- Study completion14 Jul 2014
Why it stopped: Development Halted
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,474 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
- NCT02246920
- Sponsor's protocol ID
- 71336007
- Status last verified
- May 2023
- First submitted
- 18 Sep 2014
- Last updated
- 8 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. 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 Therapeutic Equivalence of Fluticasone Propionate Nasal Spray, 50 mcg With Flonase® Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02246920
- Acronym / sponsor ID
- 71336007
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Bioequivalence, Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development Halted
- Enrolment
- 1,474 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 14 Jul 2014 (actual)
- Study completion
- 14 Jul 2014 (actual)
- First posted
- 23 Sep 2014 (estimated)
- Results
- Posted 8 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This double-blind, randomized, placebo-controlled, parallel group, multi-site study has been designed to compare the safety and efficacy of a generic Fluticasone propionate Nasal Spray, 50 mcg (Teva Pharmaceuticals USA) to the FDA Reference Listed Drug, Flonase® (fluticasone propionate) 50 mcg nasal spray (GlaxoSmithKline), in the relief of the signs and symptoms of Seasonal Allergic Rhinitis. Additionally, both the test and reference formulations will be tested for superiority against a placebo nasal spray.
Study design
- Primary purpose
- Other
- 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: Fluticasone propionateFluticasone propionate Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days |
| Reference Listed Drug | Active comparator | Drug: Flonase®Flonase® (fluticasone propionate) Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days |
| Placebo | Placebo comparator | Drug: PlaceboSaline Placebo Nasal Spray; 4 total sprays/day for 14 days |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 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 consecutive 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 (35 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 of the study is being conducted. The results of all positive shin allergen tests 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 that 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 |
|---|---|---|
| Fluticasone propionate50 mcg/actuation Nasal Spray | Drug | Investigational Test Product |
| Flonase®Also: Fluticasone propionate (generic name)50 mcg/actuation Nasal Spray | Drug | Reference Listed Drug |
| PlaceboInactive Nasal Spray | Drug | Placebo |
Primary outcome
Change From Baseline in Average AM/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14.
Time frame: 2 week treatment period: Day 0-14
Total Nasal Symptom Score (TNSS) is defined as the sum of the patient-rated nasal symptom severity scores for the following four allergy symptoms: Runny Nose, Nasal Congestion, Itchy Nose, and Sneezing. The severity score for each symptom will be based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The higher the score, the worse the symptoms of the 4 allergy categories are (runny nose, nasal congestions, itchy nose, and sneezing. The primary analysis for determining the therapeutic equivalence of the Test and Reference treatments will be based on each treatment's mean change from baseline for average rTNSS over the 2 week randomization treatment period. The Per-Protocol Population (PPP) will be used for the primary analysis of bioequivalence. The Modified Intent to Treat Population (mITT) will be used for Superiority Analysis.
1 secondary outcome
Change From Baseline in Average Instantaneous Total Nasal Symptom Score (iTNSS) Over Days 1 to 14.
Time frame: 2 week treatment period: Day 0 to Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- 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.
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 Fluticasone propionate and Flonase® 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 7 inclusion and 35 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: stopped early, as of the sponsor's last update on 8 Jun 2023. 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?
Yes. Results are posted in the registry (first posted 8 Jun 2023). 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?
Change From Baseline in Average AM/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14. (time frame: 2 week treatment period: Day 0-14). 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 8 Jun 2023.